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RULE PROPOSALS
VOLUME 42, ISSUE 2
ISSUE DATE: JANUARY 19, 2010
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF PHARMACY

Proposed Readoption with Amendments: N.J.A.C. 13:39
Proposed Repeals: N.J.A.C. 13:39-5.9, 5.10, 9.7 and 9.9
Proposed New Rules: N.J.A.C. 13:39-1.7, 4.8, 7.20 and 7.21
Proposed Repeals and New Rules: N.J.A.C. 13:39-4.7 and 7.2
Proposed Recodification with Amendments: N.J.A.C. 13:39-4.12 as 4.9

Board of Pharmacy Rules

Authorized By: Joanne Boyer, Executive Director, Board of Pharmacy.

Authority: N.J.S.A. 45:14-47 and 45:1-15.1.

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2010-025.

Submit comments by March 20, 2010 to:
Joanne Boyer, Executive Director
Board of Pharmacy
P.O. Box 45013
Newark , NJ 07101

The agency proposal follows:

Summary

The Board of Pharmacy (the Board) is proposing to readopt N.J.A.C. 13:39 with amendments and new rules. These rules are scheduled to expire on December 10, 2009, pursuant to Executive Order No. 66 (1978) and N.J.S.A. 52:14B-5.1. Because this notice of readoption has been filed prior to December 10, 2009, the expiration date of the rules in Chapter 39 is extended by 180 days, to June 8, 2010, pursuant to N.J.S.A. 52:14B-5.1c.

In compliance with the Executive Order, the Board undertook a thorough review of the existing provisions of N.J.A.C. 13:39 in order to delete unnecessary rules and to clarify existing provisions. The Board believes that the rules proposed for readoption, as amended, are necessary, reasonable, understandable and responsive to the purposes for which they were promulgated.

The following is a summary of the existing rules of Chapter 39 that the Board proposes to readopt with amendments, as well as a summary of proposed new rules.

Subchapter 1 sets forth rules of general applicability. The Board is proposing a technical amendment to N.J.A.C. 13:39-1.1, which sets forth the purpose and scope of the subchapter, to provide the correct reference to the Board's enabling statute. The New Jersey Pharmacy Practice Act, N.J.S.A. 45:14-40 et seq. became effective in 2004. Reference to the prior pharmacy act, N.J.S.A. 45:14-1 et seq., in N.J.A.C. 13:39-1.1 and in all other rules throughout Chapter 39, are proposed to be deleted and replaced with a reference to the new Pharmacy Practice Act.

The Board is also proposing amendments to N.J.A.C. 13:39-1.1 to clarify that the rules in Chapter 39 apply to all applicants for permits, licensure or registration by the Board. The Board notes that it is also proposing to delete the reference to "registered" pharmacist in N.J.A.C. [page=133] 13:39-1.1 and throughout the rules in Chapter 39 to ensure consistency with the terminology utilized in the new Pharmacy Practice Act. Under the prior pharmacy act, and in the majority of the Board's current rules, pharmacist and pharmacies are referred to as "registered." Under the Pharmacy Practice Act, however, pharmacists are licensed and pharmacies are permitted by the Board. All references to "registered" pharmacist and "registered" pharmacy are proposed to be deleted and replaced with "pharmacist" and "pharmacy" where applicable. Consistent with these changes, the Board is proposing to amend the definitions of "pharmacist" and "pharmacy" in N.J.A.C. 13:39-1.2 to reflect the statutory definitions for these terms under the Pharmacy Practice Act. In addition, the Board is proposing to delete the definitions of "authorized prescriber" and "licensed practitioner" in N.J.A.C. 13:39-1.2 and is proposing a single definition for the term "practitioner" to ensure consistency with the terminology utilized in the Pharmacy Practice Act. All references to "authorized prescriber" or "licensed practitioner" in N.J.A.C. 13:39 are being amended to refer to "practitioner."

The Board is also proposing amendments to the current definitions of "compounding," "dispense or dispensing" and "drug or medicine" to make the definitions consistent with the definition of these terms in the Pharmacy Practice Act. As amended, "compounding" means the preparation, mixing, assembling, packaging and labeling of a drug or device as the result of a practitioner's prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching or chemical analysis and not for sale or dispensing. The definition also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. The definition of "dispense or dispensing" is being amended to include a reference to both medication orders and biologicals. The definition is also being amended to include the compounding and packaging of medications for the subsequent administration to, or use by a patient. The definition of "drug or medicine" is being amended to refer to "drug or medication."

The Board is proposing to amend the definition of "immediate personal supervision" to clarify that such supervision entails the pharmacist being responsible for checking the accuracy and appropriateness of the actions of pharmacy technicians, interns and externs. The Board is proposing amendments to the definition of "pharmaceutical services" to correct typographical errors, and to the definition of "pharmacy technician" to reflect the fact that such individuals are now registered with the Board and must work under the immediate personal supervision of a pharmacist.

N.J.A.C. 13:39-1.3 sets forth the Board's fee schedule. The Board is proposing to amend N.J.A.C. 13:39-1.3(a)1 to delete the $ 60.00 yearly fee for the distribution of minutes and agenda. The Board no longer provides these documents for a fee. Board minutes and agenda are available free of charge on the Board's website at http://www.njconsumeraffairs.gov/pharm/.

N.J.A.C. 13:39-1.4 concerns the payment of penalties and currently provides that any fines imposed by the Board must be paid within 10 calendar days of receipt of a penalty letter or final order. The Board is proposing to amend N.J.A.C. 13:39-1.4 to provide licensees, registrants and permit holders with additional time to remit payment. The proposed amendments provide that payment must be received within 15 business days of the finalization of any penalty letter or order. N.J.A.C. 13:39-1.5, concerning opportunities to appear before the Board, and N.J.A.C. 13:39-1.6, which sets forth requirements for obtaining a waiver of Board rules, are proposed to be readopted without change. The Board is proposing a new rule at N.J.A.C. 13:39-1.7 providing that if an applicant for a permit, license or registration fails to complete the application process within two years of the date of initial application, the Board will administratively close the application. If this occurs, an applicant making reapplication to the Board will be required to resubmit all necessary documentation and fees.

The rules in Subchapter 2 set forth requirements for initial licensure. The Board is proposing that all the rules in Subchapter 2 be readopted without change, except for the deletion of "registered" pharmacist in N.J.A.C. 13:39-2.6. N.J.A.C. 13:39-2.1 requires applicants for initial licensure as pharmacists to satisfy education, internship and examination requirements. N.J.A.C. 13:39-2.2 establishes passing examinations scores. N.J.A.C. 13:39-2.3 concerns proof of good moral character. N.J.A.C. 13:39-2.4 imposes criminal history background check requirements. N.J.A.C. 13:39-2.5 provides that an applicant's violation of N.J.S.A. 45:1-21 or any law related to the practice of pharmacy may result in the Board's refusal to issue a license. N.J.A.C. 13:39-2.6 imposes internship and externship practical experience requirements. N.J.A.C. 13:39-2.7 establishes pharmacy intern registration requirements.

Subchapter 2A concerns requirements for reciprocal licensure. N.J.A.C. 13:39-2A.1 sets forth requirements for obtaining a reciprocal license in New Jersey for those pharmacists who have been duly licensed in reciprocating states. N.J.A.C. 13:39-2A.2 establishes proof of good moral character requirements. N.J.A.C. 13:39-2A.3 provides that any violation of any law related to the practice of pharmacy by an applicant for reciprocal licensure may result in the Board's refusal to issue a license. N.J.A.C. 13:39-2A.4 requires an applicant for reciprocal licensure to undergo a criminal history background check. N.J.A.C. 13:39-2A.5 requires such applicants to pass the Multistate Jurisprudence Examination. The Board is proposing that all of the rules in subchapter 2A be readopted without change.

Subchapter 3 sets forth requirements for pharmacists. N.J.A.C. 13:39-3.1 concerns the authorization to practice and requires the display of the license when issued. N.J.A.C. 13:39-3.2 concerns the issuance of replacement licenses. N.J.A.C. 13:39-3.3 and 3.4 impose requirements for notice of change of name and change of address. N.J.A.C. 13:39-3.5 imposes requirements for obtaining a verification of licensure. N.J.A.C. 13:39-3.6 prohibits the reproduction of licenses. N.J.A.C. 13:39-3.7 sets forth requirements for biennial license renewal. N.J.A.C. 13:39-3.8 establishes requirements for reinstatement from a license suspension. N.J.A.C. 13:39-3.9 concerns the election of inactive licensure status. N.J.A.C. 13:39-3.10 prohibits steering arrangements between pharmacists and practitioners. N.J.A.C. 13:39-3.11 sets forth general responsibilities of pharmacists. The Board is proposing that the rules in Subchapter 3 be readopted without change, except for the deletion of the references to "registered" pharmacist in N.J.A.C. 13:39-3.1, 3.3, 3.4 and 3.5 and in the subchapter heading.

The rules in Subchapter 3A concern continuing education requirements. N.J.A.C. 13:39-3A.1 requires licensees to complete 30 credits of continuing education per biennial renewal period. The rule also provides that beginning with the renewal period that commenced in May 2005, the 30 credits must include three credits in New Jersey pharmacy law. The Board is proposing to delete the reference to the May 2005 biennial renewal period because this phrase in language is no longer necessary.

N.J.A.C. 13:39-3A.2 establishes criteria for continuing education credits. The rule provides, in part, that licensees may take courses or programs offered by providers approved by the American Council on Pharmaceutical Education (ACPE), or courses or programs that have been pre-approved by the Board. The Board is proposing to amend the rule to include a new subsection (b) to establish a process by which licensees may apply to the Board for continuing education credit for attending programs or courses that have not been approved by ACPE or by the Board. Under the proposed amendments, a licensee seeking credit for attendance at a program or course that is not offered by an ACPE-approved provider, or that has not been pre-approved by the Board, must submit to the Board the same information about the course that a sponsor seeking course pre-approval would be required to submit. A licensee must also submit the $ 10.00 continuing education review fee provided for in the Board's fee schedule, and must submit a verification of attendance.

N.J.A.C. 13:39-3A.3 concerns credit hour calculations. N.J.A.C. 13:39-3A.5 concerns the waiver of continuing education requirements. N.J.A.C. 13:39-3A.6 establishes the responsibilities of continuing education sponsors. N.J.A.C. 13:39-3A.7 provides that the Board may monitor continuing education courses. The Board proposes that these rules be readopted without change. The Board is proposing an amendment to N.J.A.C. 13:39-3A.4, concerning credit hour reporting procedures. Currently, subsection (a) of the rule provides that a licensee must specify on his or her license renewal application the number of continuing education credits completed. Because completion of 30 continuing education credits is required for license renewal, the Board is [page=134] amending the subsection to clarify that a licensee must specify on his or her renewal application that the required number of continuing education credits has been completed.

Subchapter 4 contains the rules applicable to pharmacy permit holders. N.J.A.C. 13:39-4.1 establishes eligibility and application requirements for pharmacies and pharmacy departments. The Board is proposing to readopt the rule with minor amendments for clarification purposes and with deletion of the reference to "registered" pharmacist. N.J.A.C. 13:39-4.2 and 4.3 concern the issuance and display of permits. Both rules refer to pharmacies and "other licensed establishments" regulated by the Board. The Board is proposing to delete the reference to "other licensed establishment" in both rules because the Board licenses pharmacies only. The Board is proposing to further amend N.J.A.C. 13:39-4.3 to clarify that the permit holder must display in the pharmacy the "current" permit issued by the Board.

N.J.A.C. 13:39-4.4, which establishes requirements for the continued operation of a pharmacy upon the death of an owner, is proposed to be readopted without change. N.J.A.C. 13:39-4.5 establishes requirements for change of ownership and asset acquisition. The Board is proposing to replace existing subsection (a) of the rule because the provision fails to address the various changes in ownership that may occur. The proposed new subsection imposes requirements for changes of ownership in three distinct situations. When a complete change in ownership occurs and none of the current owners retains any ownership interest, the proposed amendments provide that the new owner must submit to the Board, within 10 business days of the change, a new permit application with the requisite fee, and an inventory of the pharmacy's controlled substances. The new owner may request a new pharmacy permit number when this type of change occurs. When a reallocation of ownership interests occurs among existing owners, the proposed amendments provide that the owners must submit to the Board, within 10 business days of the change, an affidavit explaining the asset reallocation. A new pharmacy permit number will not be issued when this type of change occurs. When the existing ownership is changed through the addition of a new owner or the subtraction of an existing owner, the owners must submit to the Board, within 10 business days of the change, a new permit application and the new permit application fee. The new owner may request a new pharmacy permit number when this type of change occurs. Existing subsections (b) and (c) are proposed to be readopted without change.

N.J.A.C. 13:39-4.6, concerning changes to corporate officers or stockholders, is proposed to be readopted without change. The Board is proposing to repeal existing rule N.J.A.C. 13:39-4.7 that concerns change of pharmacy location. In its place, the Board is proposing a new rule that establishes requirements for change of location and change of address of a licensed premise. The proposed new rule provides that when a permit holder intends to change the physical location and address of the permitted premises, the permit holder must apply to the Board at least 30 days in advance for a new pharmacy permit. If the change in location and address will result in the temporary closing of the pharmacy, the permit holder must comply with Board's requirements for discontinued pharmacies. The permit holder must submit a new permit application and fee, and the Board will issue an amended pharmacy permit reflecting the new location and address of the pharmacy. Before an amended permit may be issued to the permit holder for the new location, however, the Board shall have inspected and approved the premises, fixtures, equipment and inventory of the new location. The permit holder must ensure that the prescription and profile records from the pharmacy's previous location and address are maintained consistent with the Board's existing record retention requirements after the location and address change. The new rule also provides that whenever there is a change in a pharmacy's address but no change in the physical location of the licensed premises, the permit holder must, within 10 business days of the address change, submit an affidavit to the Board explaining the change.

The Board is also proposing a new rule at N.J.A.C. 13:39-4.8 concerning pharmacy remodeling. The new rule provides that prior to the remodeling of a pharmacy or pharmacy department that will entail a change of the location or size of the prescription area, or a change in the dimensions of the licensed premises, the permit holder must notify the Board at least 30 days in advance of the remodel. The permit holder must submit plans for the continuation of pharmacy operations during the remodeling process, and the anticipated completion date. If the remodeling will result in the temporary closing of the pharmacy, the permit holder must comply with the Board's discontinued pharmacy rule. The permit holder must notify the Board upon completion of the remodeling process. Within 60 days of completion, the Board will inspect the premises, fixtures, equipment and inventory of the remodeled pharmacy.

In order to better organize the remaining rules in Subchapter 4, the Board is proposing that existing rule N.J.A.C. 13:39-4.12, concerning change of name, be recodified as N.J.A.C. 13:39-4.9. The Board is proposing to further amend the rule to require a permit holder to apply for an amended permit at least 30 days before changing a pharmacy name. The permit holder must submit a new permit application and fee. Existing rule N.J.A.C. 13:39-4.8, concerning discontinued pharmacies, is proposed to be recodified as N.J.A.C. 13:39-4.10, with an amendment to correct a reference to "licensed" pharmacy. Existing rule N.J.A.C. 13:39-4.9, which concerns availability of records upon the closing of a pharmacy, is proposed to be recodified as N.J.A.C. 13:39-4.11 with amendments. The Board is proposing to amend subsection (a) of the rule, which provides, in part, that when a pharmacy ceases operation, the licensee must make every effort to notify patrons of their right to obtain copies of currently valid prescriptions. The proposed amendments to the rule provide that this obligation belongs to the permit holder. In addition, the proposed amendments clarify that consumers must be advised of their right to obtain copies of their patient profile record, and that a notice to consumers regarding the pharmacy's closing must be published in a newspaper whose circulation encompasses the geographic area in which the pharmacy is located.

Existing rule N.J.A.C. 13:39-4.10, concerning a pharmacy's business hours and unauthorized closings, is proposed to be recodified as N.J.A.C. 13:39-4.12, with minor amendments to correct internal cross-references and to delete references to "other Board licensed establishments." Existing rule N.J.A.C. 13:39-4.11, which concerns replacement permits, is proposed to be recodified as N.J.A.C. 13:39-4.13, without change. Existing rule N.J.A.C. 13:39-4.13, which concerns reproduction of permits, is proposed to be recodified as N.J.A.C. 13:39-4.14 with minor changes for clarification purposes.

Existing rule N.J.A.C. 13:39-4.14, which imposes security requirements for pharmacies and pharmacy departments, is proposed to be recodified as N.J.A.C. 13:39-4.15 with technical amendments and with deletions of the references to "registered" pharmacist. N.J.A.C. 13:39-4.15, concerning specialized permits, is proposed to be recodified as N.J.A.C. 13:39-4.16 without change. N.J.A.C. 13:39-4.16, which prohibits a permit holder from entering into an arrangement with a practitioner for the purpose of directing or diverting patients to or from a specified pharmacy, is proposed to be recodified as N.J.A.C. 13:39-4.17 with an amendment to clarify that permit holders may not enter into such arrange

arrangements for the purpose of directing or diverting patients to or from a specific pharmacy for the purpose of filling of their prescriptions.

Existing rule N.J.A.C. 13:39-4.17, which sets forth the responsibilities of permit holders, is proposed to be recodified as N.J.A.C. 13:39-4.18 with amendments to correct references to the Pharmacy Practice Act. Existing rule N.J.A.C. 13:39-4.18, which establishes requirements for pharmacies engaged in central prescription handling, is proposed to be recodified as N.J.A.C. 13:39-4.19. In addition to deletions of references to "licensed" pharmacies throughout the rule, the Board is proposing amendments to the labeling requirements set forth in paragraph (d)4 of the rule, consistent with the provisions of P.L. 2009, c. 91, codified as N.J.S.A. 24:6E-9, which was enacted on July 31, 2009. P.L. 2009, c. 91 provides that if a non-brand drug product is dispensed, the pharmacist must include on the label of the dispensed product the brand name drug and the name of the generic. Currently, the Board's rule requires the dispensed product label to include the brand name or the generic name of the medication, and if a generic medication, the name of the manufacturer. The Board is proposing to amend this requirement to provide that if a generic is dispensed, the brand name and the name of the generic must appear on the label, consistent with the provisions of P.L. 2009, c. 91, in the following form: "------- Generic for --------."

Existing rule N.J.A.C. 13:39-4.19, concerning the registration of out-of-State pharmacies, is proposed to be recodified at N.J.A.C. 13:39-4.20 [page=135] with deletion of references to "registered" pharmacist and with clarifying amendments to paragraph (c)5. Paragraph (c)5 provides that an out-of-State pharmacy seeking to register with the Board must submit a completed application for registration that must include a letter of good standing from the licensing authority in the state in which the out-of-State pharmacy is licensed, permitted or registered. The proposed amendments clarify that the letter of good standing must be submitted from the state licensing authority in the state in which the out-of-State pharmacy is located. Existing rule N.J.A.C. 13:39-4.20, which sets forth procedures for pharmacist-administered immunizations, is proposed to be recodified as N.J.A.C. 13:39-4.21 without change.

Subchapter 5 contains rules relating to retail pharmacy facilities. The Board is proposing amendments to N.J.A.C. 13:39-5.1, which sets forth the purpose and scope of the subchapter, to clarify that the requirements in the subchapter also apply to institutional pharmacies filling prescriptions for outpatient use. The proposed amendment will make the rule consistent with the provisions of N.J.A.C. 13:39-9.1(b), which requires an institutional pharmacy filling prescriptions for outpatient use to comply with all retail pharmacy requirements in Chapter 39. N.J.A.C. 13:39-5.2, concerning pharmacy access and egress, is proposed to be readopted without change. N.J.A.C. 13:39-5.3, concerning the display of signs, is proposed to be readopted with amendments to delete the reference to "registered" pharmacist.

N.J.A.C. 13:39-5.4 sets forth the spatial requirements of the prescription area. N.J.A.C. 13:39-5.5 sets forth prescription counter requirements. N.J.A.C. 13:39-5.6 establishes requirements for the prescription area sink. The Board is proposing that these rules be readopted without change. The Board is proposing an amendment to N.J.A.C. 13:39-5.7, concerning storage and adequate stock, to provide that all prescription drugs and chemicals must be stored under proper lighting, ventilation and temperature control conditions. The Board is also proposing to amend the section heading for clarification purposes to remove "storage".

N.J.A.C. 13:39-5.8 establishes a list of minimum equipment and supplies that must be maintained in the prescription area. N.J.A.C. 13:39-5.8(a)1 currently provides, in part, that a pharmacy must possess an up-to-date pharmaceutical reference text encompassing the general practice of pharmacy. The Board is proposing to delete this requirement, and to instead require the pharmacy to possess a reference text that encompasses the particular pharmaceutical services provided by the pharmacy. In addition, N.J.A.C. 13:39-5.8(a)2 requires a pharmacy to maintain an over-the-counter Schedule V Record Book. The Board is proposing to amend this requirement to clarify that this record book must contain all required information for Schedule V medications consistent with the requirements for controlled drugs provided for in N.J.A.C. 8:65-7.19(a)5. The proposed amendments also provide that a pharmacy may utilize an electronic recording system to maintain Record Book information if permitted by Federal law pursuant to 21 CFR 1306.26 and 1304.04.

The Board is also proposing to delete certain equipment and supplies from the list in subsection (a) of the rule and move these items into a new subsection (b) that will delineate minimum equipment and supplies that must be maintained by pharmacies that engage in non-sterile compounding. Subsection (b) provides that all prescription areas where non-sterile compounding is performed must contain: a Class A prescription balance with a complete set of metric weights or an equivalent electronic weighing device; a glass mortar and pestle; glass funnels; stirring rods; ointment tile or parchment paper; and suppository molds. The remaining requirements in subsection (a) are proposed to be recodified, with additional amendments. The Board is proposing to amend the requirement for auxiliary labels in order to delete the reference to poison labels, which are no longer necessary under the new Pharmacy Practice Act.

In addition, the Board is proposing amendments to the requirement that pharmacies possess the current Drug Utilization Review Council Formulary. The proposed amendments instead require pharmacies to possess the 29th edition of the list of "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book," consistent with Department of Health and Senior Services rules set forth at N.J.A.C. 8:71-1. The Board is proposing to incorporate by reference, as amended and supplemented, the 29th edition of the Orange Book. The proposed amendments also provide information with respect to obtaining copies of the Orange Book. The current requirement that pharmacies possess assorted stock of prescription containers and child safety closures or caps, is proposed to be amended to require such equipment to meet United States Pharmacopoeia/National Formulary standards on light resistance and tightness. The Board is also proposing to require all pharmacies to maintain copies of, or have access to, current State statutes and rules relating to the practice of pharmacy. Proposed new subsection (c) of the rule requires the prescription area and all related equipment and supplies to be kept in a clean, orderly and sanitary condition at all times. Lastly, the Board is proposing to amend the heading of the rule for clarification purposes.

The Board is proposing to repeal existing rule N.J.A.C. 13:39-5.9, requiring the prescription area to be maintained in a clean and orderly condition, because this requirement is now captured under proposed new N.J.A.C. 13:39-5.8(c). Existing rule N.J.A.C. 13:39-5.11, concerning prescription balances, scales, weights and automatic counting devices, is proposed to be recodified as N.J.A.C. 13:39-5.9 for organizational purposes. The Board is also proposing a new subsection (b) in the rule to require that counting trays or counting devices be used to count all oral, solid drugs or medications. Existing rule N.J.A.C. 13:39-5.10, limiting a pharmacy's use of commercial televisions, is proposed to be repealed. The Board believes that decisions concerning the use of televisions and other electronic devices in the pharmacy should be left to the discretion of the pharmacist-in-charge.

Existing rule N.J.A.C. 13:39-5.12, which imposes restrictions on the storage of prescription legend drugs and controlled dangerous substances, is proposed to be recodified as N.J.A.C. 13:39-5.10, with technical amendments, and with an amendment to subsection (b) to clarify that storage of drugs in a health care facility must comport with the Board's drug storage requirements for such facilities in N.J.A.C. 13:39-9.23. The Board is also proposing a new subsection (c) in the rule to provide that prescription legend drugs, devices and controlled dangerous substances that are received during hours the pharmacy or pharmacy department is closed, must be stored consistent with the security requirements of N.J.A.C. 13:39-4.15(b)3.

Subchapter 6 includes rules relevant to the duties of the pharmacist-in-charge and other pharmacy personnel. N.J.A.C. 13:39-6.1, which establishes the purpose and scope of the subchapter, is proposed to be readopted without change. N.J.A.C. 13:39-6.2, which sets forth the duties of the registered pharmacist-in-charge, is proposed to be readopted with several amendments. In addition to deleting the references to "registered" pharmacist and "other Board-licensed establishments," the Board is proposing amendments to subsection (c), which currently provides that a pharmacist shall not assume the responsibilities of pharmacist-in-charge for more than one pharmacy or pharmacy department simultaneously. Proposed amendments to this subsection provide an exception to this prohibition. Under the proposed amendments, if an area within a health care facility is permitted as both an institutional pharmacy and a retail pharmacy, the health care facility may employ one individual to act as the pharmacist-in-charge for both the institutional pharmacy and the retail pharmacy. The Board believes that this amendment will allow a pharmacy that holds both retail and institutional permits to eliminate administrative redundancies caused by the retention of two pharmacists-in-charge.

The Board is also proposing clarifying amendments to N.J.A.C. 13:39-6.2(f), which currently provides, in part, that the pharmacist-in-charge must ensure that adequate staffing is present in the pharmacy. The proposed replacement of paragraph (f)1 provides that the pharmacist-in-charge must ensure that the pharmacy is staffed by sufficient, competent personnel in keeping with the size, scope and complexity of the pharmaceutical services provided by the pharmacy. The Board is proposing amendments to paragraph (f)9, to clarify that the pharmacist-in-charge must ensure that the pharmacy and its personnel provide pharmaceutical services in accordance with acceptable professional standards.

N.J.A.C. 13:39-6.3 requires identification tags to be worn by all personnel working in the pharmacy. The Board is proposing to amend the rule to exclude from this requirement personnel engaged in the compounding of sterile preparations. The proposed amendment will [page=136] ensure consistency with the requirements of Subchapter 11. In addition, the Board is proposing to amend the rule to require the name tag to include the first initial of the person's last name, in addition to the currently required first name and job title, consistent with the requirements of N.J.S.A. 45:14-80(h) of the Pharmacy Practice Act. N.J.A.C. 13:39-6.4, which authorizes pharmacists to take meal and restroom breaks, is proposed to be readopted without change. The Board is proposing to amend N.J.A.C. 13:39-6.5, which authorizes prescription handling by pharmacy externs, interns and pharmacy technicians provided audit trail documentation is maintained, to provide a cross-reference to the Board's audit trail rule in N.J.A.C. 13:39-7.6. The provisions in N.J.A.C. 13:39-6.5 that duplicate the audit trail requirements in N.J.A.C. 13:39-7.6 are proposed to be deleted. N.J.A.C. 13:39-6.6, which establishes requirements for pharmacy technician registration, is proposed to be readopted without change, except for an amendment to subsection (e) to provide the correct reference to Pharmacy Practice Act. N.J.A.C. 13:39-6.7, concerning authorization to practice as a pharmacy technician and display of registration, is proposed to be readopted with minor amendments to correct the reference to "licensed" pharmacy in subsection (c).

N.J.A.C. 13:39-6.8 establishes procedures that a pharmacy technician must comply with in order to replace a lost or destroyed registration. N.J.A.C. 13:39-6.9 establishes procedures that pharmacy technicians must comply with when they change the name under which they have been practicing. N.J.A.C. 13:39-6.10 sets forth procedures for a pharmacy technician to change his or her address of record. N.J.A.C. 13:39-6.11 permits a pharmacy technician to seek a written verification of good standing from the Board. N.J.A.C. 13:39-6.12 prohibits the reproduction of a pharmacy technician's initial, biennial or wallet-sized registration. N.J.A.C. 13:39-6.13 imposes requirements for pharmacy technician registration renewal. N.J.A.C. 13:39-6.14 sets forth requirements for pharmacy technician reinstatement from a suspended registration. The Board is proposing that these rules be readopted without change.

N.J.A.C. 13:39-6.15 sets forth pharmacy technician duties and permissible pharmacist-technician ratios. In addition to amendments to correct terminology throughout the rule, existing subsection (b), which provides that pharmacy technicians may accept authorization for prescription refills, is proposed to be recodified as paragraph (a)5 for clarification purposes because subsection (a) currently delineates the duties that a technician may perform. Existing subsections (c) through (i) are proposed to be recodified as (b) through (h), with amendments to correct cross-references to reflect this recodification and other general amendments discussed above.

The rules in Subchapter 7 contain rules relevant to medication dispensing and the maintenance of prescription records. N.J.A.C. 13:39-7.1 concerns requirements for valid prescriptions. The Board is proposing to amend the heading of the rule to delete the reference to "out-of-State prescriptions" because the language is superfluous. In addition to technical amendments to correct references to the Pharmacy Practice Act and to "prescriber," the Board is proposing to amend the references to written prescriptions in subsections (a) and (b) to, instead, refer to issued prescriptions, in order to avoid confusion about the rule's application to faxed or electronically transmitted prescriptions.

N.J.A.C. 13:39-7.2, which concerns lack of directions on a prescription, is proposed to be repealed. In its place, the Board is proposing a new rule at N.J.A.C. 13:39-7.2 which provides that, if a practitioner fails to include on the original prescription any information that he or she is required to include pursuant to rules governing the practitioner's professional practice, the pharmacist is required to obtain this information. The new rule continues to provide that if the practitioner has failed to include directions for use and the practitioner cannot be contacted, the pharmacist must indicate on the prescription label the words "use as directed" or "as ordered by the physician" or similar words to the same effect. The proposed new rule also provides that all information required for a valid prescription must be recorded on the prescription, or in the pharmacy's patient profile record system or other manual or electronic file.

N.J.A.C. 13:39-7.3 concerns authorization for renewal prescriptions. The Board is proposing to amend subsection (a), which currently provides that a prescription shall not be renewed without specific authorization from the prescriber, to clarify that such authorization also may be obtained from the practitioner's authorized agent and that the prescription may not be filled or refilled after one year from the date the original prescription was issued. The proposed amendments also provide that a pharmacist obtaining authorization from a practitioner's authorized agent must document the name and title of the agent. In addition to amendments to correct terminology, the Board is proposing amendments to subsection (b) to delete the requirement that a pharmacist reduce to writing new prescriptions obtained from a practitioner. Proposed new subsection (c) provides that prescription information obtained from a practitioner must be documented at the time of receipt as a new prescription in either hard copy form or by direct entry into the pharmacy's electronic prescription records system.

The Board is proposing clarifying amendments to N.J.A.C. 13:39-7.4, which concerns emergency dispensing. The Board is proposing to amend paragraph (a)1, which currently requires the pharmacist to ascertain, by direct communication with the patient or caregiver, that the medication for which an emergency supply is being requested was prescribed for that patient, to provide that the pharmacist must require the patient or caregiver to provide suitable identification. This communication must be documented in the patient profile record system or in the pharmacy's other manual or electronic files. The proposed amendments also require the pharmacist to document the dispensing of the emergency supply in the prescription record system. The Board is proposing a new subsection (b) to provide that a pharmacist may dispense an emergency supply of a Schedule II controlled dangerous substance in the absence of a current, valid prescription upon receipt of oral authorization from a practitioner, consistent with the requirements of the controlled dangerous substances rule set forth at N.J.A.C. 8:65-7.8. In light of this change, the Board is proposing to delete the prohibition in subsection (a) against dispensing emergency supplies of controlled dangerous substances.

N.J.A.C. 13:39-7.5 requires Federal Food and Drug Administration (FDA) approval for dispensed medications. The Board is proposing to amend subsection (b), which requires storage and dispensing of Investigational New Drugs to be provided in cooperation with the principal investigator, to also require labeling of such drugs to be carried out in cooperation with the principal investigator. The rule also currently provides that a pharmacy participating in experimental research must comply with Federal Department of Health and Human Services regulations concerning the protection of human research subjects. The Board is proposing to amend the rule to require pharmacies also to comply with the New Jersey Department of Health and Senior Services' Policy on the Protection of Human Research Subjects, which is incorporated into the rule by reference, as amended and supplemented and available at http://www.state.nj.us/health/irb/policies.shtml.

The Board is proposing that N.J.A.C. 13:39-7.6, which requires the maintenance of an audit trail for records and documents, be amended to clarify, in new subsection (e) that a pharmacy must maintain prescription records for controlled dangerous substances as required by Federal law consistent with the provisions of 21 CFR 1304.04. N.J.A.C. 13:39-7.7 requires a pharmacy to provide patients with copies of their prescriptions. In addition to clarifying amendments to subsection (b), the Board is proposing to amend the rule to provide that pharmacies must also comply with a patient's request for copies of his or her patient profile. The Board is also proposing to amend the heading of the rule to refer to copies of prescriptions and patient profiles.

N.J.A.C. 13:39-7.8 concerns the transfer of prescriptions between pharmacies. Subsection (d) currently provides, in part, that a prescription for a Schedule III, IV or V controlled substance may be transferred between pharmacies one time only. The Board is proposing to amend subsection (d) to ensure consistency with State and Federal controlled dangerous substance requirements. The proposed amendments to subsection (d) provide that a prescription for a Schedule III, IV or V controlled substance that has been transferred shall not be transferred a second time. This prohibition shall not apply to the transfer of such prescriptions between pharmacies engaged in central prescription handling pursuant to N.J.A.C. 13:39-4.18(e) and to pharmacies that share a real-time, on-line database consistent with the Federal requirements in 21 CFR 1306.25. Existing subsections (e) and (f), which provide for the transfer of prescriptions by electronic means and telephone, respectively, [page=137] are proposed to be combined into one subsection to eliminate redundancy. Existing subsection (e) is proposed to be deleted and subsection (f) is proposed to be recodified as subsection (e) with amendments, which clarify that a prescription may be transferred between pharmacies for the purpose of refill dispensing by telephone, by facsimile or by electronic means. Recodified subsection (e) continues to impose requirements on the sending and receiving pharmacies when a prescription transfer occurs. The Board is proposing to amend the requirements in recodified paragraphs (e)1 and 2 to provide that both the sending and receiving pharmacies must record the name and address, or store identifier, of the other pharmacy in their records. The Board is proposing further amendments to the information that must be retained by the receiving pharmacy. The Board is proposing to delete the requirement that such pharmacies document in their record the date of issuance of the original prescription and the complete refill record from original prescription because such information is not relevant to the receiving pharmacy. The Board, however, believes that the date the prescription was last filled is information that the receiving pharmacy should maintain as part of its record, and is proposing to amend the rule accordingly.

The Board is proposing that N.J.A.C. 13:39-7.9, concerning the filing and storage of controlled substance prescriptions, be readopted without change, except for amendments to correct references to "prescriber." N.J.A.C. 13:39-7.10 and 7.11 concern prescriptions transmitted by facsimile and electronic means. In addition to amendments to correct references to the Pharmacy Practice Act in both rules, the Board is proposing new N.J.A.C. 13:39-7.10(k) to clarify that the requirements in the rule do not preclude the facsimile transfer of information between pharmacies for purposes of transferring prescriptions under N.J.A.C. 13:39-7.8. Similar language is already included in N.J.A.C. 13:39-7.11(l) for electronic transfer of prescriptions. In addition, the Board is proposing new subsections in both rules to clarify that a pharmacist may not use a technological device to circumvent his or her responsibilities regarding verifying the validity of a prescription, or to circumvent other standards of pharmacy practice. The Board is also proposing amendments to subsection (e) of N.J.A.C. 13:39-7.11, which currently provides that an electronic prescription must contain all information required to be on a written prescription under Board of Medical Examiners regulations, except that a handwritten original signature and an NJPB is not required. The Board is proposing to amend subsection (e) to make its requirements consistent with the requirements in the Board of Medical Examiners' rule. The proposed amendments provide that the practitioner's electronic signature or other secure method of validation must be provided with the electronic prescription

unless the prescription is transmitted by the practitioner's authorized agent. If transmitted by the agent, the full name and title of the agent must be included on the transmission. The prescription cannot be signed by the agent.

The Board is proposing amendments to its labeling requirements in N.J.A.C. 13:39-7.12 based on the requirements of P.L. 2009, c. 91, codified as N.J.S.A. 24:6E-9. The proposed amendments are consistent with the amendments being proposed at N.J.A.C. 13:39-4.19, discussed above. The Board is also proposing amendments to correct references to "prescriber" in the rule and in N.J.A.C. 13:39-7.13, which concerns the use of professional judgment in the dispensing of drugs. N.J.A.C. 13:39-7.14, concerning the advertising and sale of prescription drugs, and N.J.A.C. 13:39-7.15, which imposes restrictions on the sale of Schedule V over-the-counter controlled substances, are proposed to be readopted without change. N.J.A.C. 13:39-7.16 concerns the return of prescription medications. Paragraph (c)4 currently provides that in those circumstances in which prescription medications cannot be properly returned to the original manufacturers' stock containers, the medication must be held in the pharmacy in the labeled container in which it has been repackaged. Proposed amendments to paragraph (c)4 provide that, prior to redispensing, such medications must be placed in a new container with a new label or the original label must be removed and the container must be relabeled. The Board is proposing that N.J.A.C. 13:39-7.17, concerning the disposal of unwanted drugs, and N.J.A.C. 13:39-7.18, concerning outdated and sample drugs, be readopted without change.

The Board is proposing various amendments to its patient profile record system rule in N.J.A.C. 13:39-7.19. Proposed amendments to subsection (a) clarify that a pharmacy's patient profile record system (PPRS) may be a manual or electronic system, and must enable the pharmacist to identify patient specific information. Subsection (b) details the information that must be included in the PPRS. Existing subsection (c) concerns allergy and other patient specific information that must also be recorded in the PPRS. The Board is proposing to recodify the requirements in subsection (c) into existing subsection (b) for organizational purposes. The Board is also proposing other minor amendments to subsection (b) for clarification purposes. Existing subsection (d) is proposed to be recodified as subsection (c) without change.

The provisions currently contained in N.J.A.C. 13:39-7.19(e)1 through 7 are proposed to be deleted and recodified in proposed new rules N.J.A.C. 13:39-7.20, concerning drug utilization review, and N.J.A.C. 13:39-7.21, concerning patient counseling. Specifically, the requirements currently contained in N.J.A.C. 13:39-7.19(e), (e)6 and (e)7 are proposed to be recodified in new rule N.J.A.C. 13:39-7.20. The requirements currently set forth in N.J.A.C. 13:39-7.19(e)1 through 5 are proposed to be recodified in proposed new rule N.J.A.C. 13:39-7.21. The existing requirements in paragraph (e)8 that a pharmacy maintain a profile record for each patient and that the pharmacist inquire whether other prescription drugs are being concomitantly used, are proposed to be recodified as N.J.A.C. 13:39-7.19(d) for organizational purposes. N.J.A.C. 13:39-7.19(e)9 is proposed to be deleted. Existing subsections N.J.A.C. 13:39-7.19(f) through (i) are proposed to be recodified as N.J.A.C. 13:39-7.19(e) through (h), with amendments to correct references to "prescriber." N.J.A.C. 13:39-7.19(j), which provides that failure to comply with the requirements of the section shall subject a pharmacist to disciplinary sanctions, is proposed to be deleted. Similar language is contained in N.J.A.C. 13:39-2.20 and, therefore, the provision is redundant.

Subchapter 8, which is reserved, is proposed to be readopted without change.

Subchapter 9 establishes requirements for pharmaceutical services for health care facilities. The Board is proposing that N.J.A.C. 13:39-9.1, which sets forth the purpose and scope of the subchapter, be readopted without change. N.J.A.C. 13:39-9.2 sets forth definitions of terms used throughout the subchapter. In addition to amendments to the definition of "medication order" to correct references to "prescriber," the Board is proposing to delete the definition of "unit dose drug distribution system" because the term is not used in Subchapter 9. The Board is also proposing amendments to the definition of "unit use packaging." The correct terminology for such packaging is "unit dose packaging." The Board is also amending the definition to clarify that such packaging refers to a single unit use non-parenteral medication, and that the phrase "use by" followed by the product's use by date must appear on the package. "Use by date" means the earlier of one year from the date of packaging or the expiration date on the manufacturer's container, consistent with the Board's labeling requirements in N.J.A.C. 13:39-7.12.

N.J.A.C. 13:39-9.3, which provides for the licensure of institutional pharmacies, and N.J.A.C. 13:39-9.4, which concerns contract pharmaceutical services for health care institutions, are proposed to be readopted without change. N.J.A.C. 13:39-9.5, concerning advisory committees, is proposed to be readopted without change, except for the deletion of the term "registered" pharmacist. N.J.A.C. 13:39-9.6, concerning the Pharmacy and Therapeutics Committee, is proposed to be readopted with amendments to subsection (b) that clarify that copies of a facility's committee policies and procedures must be made available to the Board upon request.

N.J.A.C. 13:39-9.7, which establishes requirements for institutional pharmacy staffing, is proposed to be repealed, and the section reserved. Requirements for pharmacy staffing are provided for in N.J.A.C. 13:39-6.2(f)1. N.J.A.C. 13:39-9.8, concerning control of the pharmacy services within the health care facility, is proposed to be readopted with amendments to correct references to "registered" pharmacist throughout the rule. N.J.A.C. 13:39-9.9, concerning generally applicable requirements for pharmaceutical services, is proposed to be repealed, and the section reserved because these requirements are duplicative of the requirements set forth in N.J.A.C. 13:39-6.2(f)9.

N.J.A.C. 13:39-9.10 concerns pharmaceutical supply, investigational drugs and controlled dangerous substances. The Board is proposing to [page=138] amend subsection (a), which currently provides that when an authorized purchasing agent, materials manager or pharmacy buyer, procures pharmaceuticals for use by the health care facility, the purchase must be supervised by the pharmacist-in-charge. The Board is proposing to amend this section to provide that such purchases must be reviewed by the pharmacist-in-charge. Subsection (b), which provides that drugs approved by the Pharmacy and Therapeutics Committee for use in the facility must be of an amount sufficient to compound or dispense all medication orders and prescriptions for the facility, is proposed to be deleted. The requirements of the subsection are duplicative of requirements imposed on the pharmacist under subsection (a). Existing subsection (c) is proposed to be recodified as subsection (b) with amendments to delete the requirement that the institutional pharmacy have an adequate inventory of drugs to assure timely initiation of routine and disaster drug therapy, and that limited quantities of drugs be placed under controlled conditions in locations within the facility to assure immediate access by authorized licensed health care personnel for use in an emergency situation. These requirements are duplicative of the drug inventory requirements in subsection (a).

Existing N.J.A.C. 13:39-9.10(d) and (e) concern investigational drugs. The Board is proposing to combine the requirements of the subsections in a single recodified subsection (c). Amendments to recodified subsection (c) provide that written policies and procedures for the control, use and accountability of Investigational New Drugs shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. In addition, the Board is proposing to amend recodified subsection (c) to provide that pharmacies participating in investigational drug trials must comply with the New Jersey Department of Health and Senior Services' Policy on the Protection of Human Research Subjects, which is incorporated by reference, consistent with the proposed amendments to N.J.A.C. 13:39-7.5. Existing subsection (f), which concerns controlled dangerous substances, is proposed to be recodified as subsection (d), with amendments to clarify that written policies and procedures for the control, use and accountability of controlled dangerous substances must be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee.

N.J.A.C. 13:39-9.11 concerns drug disbursements and written orders. Currently, the rule provides that a pharmacist must review the prescriber's original order or a copy or facsimile of the order before dispensing. The Board is proposing to amend the rule to clarify that the pharmacist must review the practitioner's original order or any copy of the original order which may be generated by any media that facilitates the reproduction of the original order. N.J.A.C. 13:39-9.12, concerning drug disbursements and oral orders, is proposed to be readopted with minor clarifying amendments. The Board is also proposing to amend subsection (e), which currently provides that a pharmacist may release to the patient at the time of discharge any remaining medication in a multiple dose container, to also permit a pharmacist to release to the patient a limited supply of other medications that the patient may need upon discharge. The Board is also proposing an amendment to paragraph (e)1 to delete the existing reference to N.J.S.A. 45:14-24 of the repealed pharmacy act. The Board is proposing to amend the labeling requirement to instead refer to the Board's existing labeling rule at N.J.A.C. 13:39-7.12.

N.J.A.C. 13:39-9.13, which requires monitoring of patient drug therapies, and N.J.A.C. 13:39-9.14, which concerns medications dispensed in an unfinished form, are proposed to be readopted without change. N.J.A.C. 13:39-9.15 concerns labeling of medications other than intravenous solutions. The Board is proposing an amendment to the rule to clarify that labeling of intravenous solutions must be consistent with the labeling requirements for sterile and non-sterile compounding set forth in Subchapter 11. The Board is proposing that N.J.A.C. 13:39-9.16, which concerns the use of a patient's own medications within the health care facility, N.J.A.C. 13:39-9.17, which concerns drug dispensing devices and N.J.A.C. 13:39-9.18, which concerns the disposal of unused medications, be readopted with amendments to correct terminology and with minor, clarifying amendments to N.J.A.C. 13:39-9.17. The Board is also proposing that N.J.A.C. 13:39-9.19, which concerns records and reports, N.J.A.C. 13:39-9.20, which concerns drug information and education and N.J.A.C. 13:39-9.21, which concerns after hours access to the institutional pharmacy, be readopted without change except for corrections to the references to "registered" pharmacist.

N.J.A.C. 13:39-9.22 concerns pharmacy facilities and space. The Board is proposing to delete subsection (c), which required that the space provided for the institutional pharmacy must be in accord with the size of the facility and the scope and complexity of the pharmaceutical services offered, because institutional pharmacies must comply with the spatial requirements of N.J.A.C. 13:39-5.4, consistent with the provisions of N.J.A.C. 13:39-5.1 and 9.1. N.J.A.C. 13:39-9.23 concerns storage and security. In addition to amendments to the rule to correct terminology, the Board is proposing amendments to paragraph (a)3 to delete superfluous language. The Board is also proposing amendments to subsection (b), which currently provides that inspections must be conducted of all medication areas located in the health care facility or any other service area of the facility at least once every two months to check for expiration or use by dates, misbranding, physical integrity, security and accountability of all drugs dispensed for use. The Board is proposing to add proper storage of medications to the list of items that must be inspected for at least once every two months. The Board is also proposing to delete the qualifier "dispensed for use" from this subsection. The Board believes that pharmacies have a duty to inspect all medications maintained in the health care facility, including medications that have not been dispensed for patient use. The proposed amendments, therefore, clarify that inspections must be carried out with respect to all medications in the facility, and not just those that are dispensed for use. The Board is proposing an additional amendment to subsection (b) concerning the preparation of inspection reports. Currently, the rule provides that inspection reports must be prepared and signed by the pharmacist, except for hospitals, where such reports can also be prepared and signed by the a pharmacy technician, intern or extern and co-signed by his or her supervising pharmacist. The Board believes that technicians, interns or externs working in health care facilities other than hospitals also should be permitted to prepare and sign inspection reports if such reports are countersigned by the supervising pharmacist. The Board is proposing to amend subsection (b) to permit such activity.

The Board is proposing to amend N.J.A.C. 13:39-9.24, which establishes equipment requirements, to delete the second sentence of the rule. The requirement that the pharmacy contain equipment sufficient to process drugs is redundant in light of the requirements delineated in the first sentence of the rule. N.J.A.C. 13:39-9.25, concerning institutional decentralized pharmacies and N.J.A.C. 13:39-9.26, concerning valid medication orders, are proposed to be readopted without change except for amendments to correct references to pharmacist and practitioner.

N.J.A.C. 13:39-9.27 concerns prescriptions and medication orders transmitted by technological devices in an institution. In addition to corrections to terminology, the Board is proposing to amend subsection (b) to delete the requirements in paragraphs (b)1 and 2 concerning transmission of prescriptions and medications orders for Schedule II, III, IV and V controlled substances. The proposed amendments provide that transmission of prescriptions for these medications must comply with the requirements for facsimile and electronic transmission set forth in N.J.A.C. 13:39-7.10 and 7.11. Consistent with this change, the Board is proposing to amend subsection (c) to delete the requirements applicable to medication orders for narcotic Schedule II drugs. Such prescriptions are covered under the requirements of N.J.A.C. 13:39-7.10 and 7.11.

Subchapter 10 contains rules for using automated medication systems. N.J.A.C. 13:39-10.1, which sets forth the purpose and scope of the subchapter, is proposed to be readopted without change. N.J.A.C. 13:39-10.2, which defines automated medication systems, is proposed to be readopted with a technical change to correct an internal cross-reference. The Board is proposing several amendments to N.J.A.C. 13:39-10.3, which authorizes the use of automated medication systems. In addition to technical changes, the Board is proposing to amend subsection (a) to clarify, that in the case of an automated medication system utilized at a location with no on-site pharmacy, the pharmacist-in-charge of the provider pharmacy must be responsible for the supervision of the operation of the system. The Board is proposing a further amendment in subsection (a) of the rule to eliminate the requirement that Board inspection of an automated medication system be made prior to use of the system. In place of this Board inspection, a pharmacy will be required to [page=139] conduct a self-inspection of the system. The inspection must be documented on a form provided by the Board. In addition, the Board is proposing to amend the requirement contained in subsection (b) that medications in the automated medication system be inspected at least monthly, to provide that such inspections must be carried out at least once every two months, consistent with the medication inspection schedule established in N.J.A.C. 13:39-9.23.

N.J.A.C. 13:39-10.4, which concerns written policies and procedures for operation of automated medication systems, is proposed to be readopted with amendments. In addition to amendments to correct terminology, the Board is proposing to require all policies and procedures for operation to include methods to identify the quality control measures in place to ensure the accuracy of the system's final dispensed product. N.J.A.C. 13:39-10.5, which establishes personnel training requirements, is proposed to be readopted with amendments to correct terminology and with a correction to the current list of persons who the pharmacist-in-charge is responsible for training in the use of the system. Currently, the list includes "licensed practitioners." This reference should have been to pharmacists and is proposed to be amended accordingly.

N.J.A.C. 13:39-10.6, 10.7 and 10.8, which require the establishment of written policies for quality assurance, recovery and preventative maintenance, respectively, are proposed to be readopted without change.

Subchapter 11 contains requirements for compounding sterile and non-sterile preparations in both retail and institutional pharmacy settings. The Board notes that the United States Pharmacopeia (USP), the official public standards-setting authority for all prescription and over-the-counter medicines manufactured or sold in the United States , recently amended its recommendations and standards concerning the compounding of sterile preparations. The Board is currently in the process of reviewing the newly adopted requirements in USP Chapter 797 to determine what amendments, if any, should be made to the Board's rules in Subchapter 11 in light of these changes. The Board anticipates that it will be undertaking rulemaking activity in the near future to address the new requirements in USP Chapter 797. At this time, however, it is proposing that all of the rules in Subchapter 11 be readopted without change.

N.J.A.C. 13:39-11.1 sets forth the purpose and scope of the subchapter. N.J.A.C. 13:39-11.2 defines relevant terms used throughout the subchapter. N.J.A.C. 13:39-11.3 sets forth environmental requirements. N.J.A.C. 13:39-11.4 establishes general requirements for permit holders seeking authority to engage in sterile compounding. N.J.A.C. 13:39-11.5 sets forth the responsibilities of the pharmacist-in-charge and the permit holder when engaging in the compounding of preparations. N.J.A.C. 13:39-11.6 concerns required supervision of pharmacy technicians, interns and externs engaged in compounding activities. N.J.A.C. 13:39-11.7 establishes training requirements. N.J.A.C. 13:39-11.8 concerns batch preparation. N.J.A.C. 13:39-11.9 concerns documentation. N.J.A.C. 13:39-11.10 concerns prescription labels.

N.J.A.C. 13:39-11.11 concerns the "use by date" of sterile compounded preparations. N.J.A.C. 13:39-11.12 establishes requirements for handling, packaging and delivery of compounded preparations. N.J.A.C. 13:39-11.13 and 11.14 require the maintenance of policy and procedure manuals and quality assurance programs. N.J.A.C. 13:39-11.15 concerns patient profile records. N.J.A.C. 13:39-11.16 through 11.23 concern various controlled environment specifications imposed upon pharmacies engaging in sterile product compounding. N.J.A.C. 13:39-11.24 requires pharmacies to maintain certain library references. N.J.A.C. 13:39-11.25 concerns the disposal of drugs and materials. N.J.A.C. 13:39-11.26 establishes security requirements for the compounding area. N.J.A.C. 13:39-11.27 is reserved.

The rules in Subchapter 12 establish requirements for nuclear pharmacies. The Board is proposing an amendment to correct terminology in the definition of "immediate personal supervision" in N.J.A.C. 13:39-12.1. N.J.A.C. 13:39-12.2, which establishes general requirements for pharmacies providing radiopharmaceutical services and N.J.A.C. 13:39-12.3, 12.4 and 12.5, which concern requirements for nuclear pharmacists with respect to space and equipment and quality control procedures, are proposed to be readopted without change.

The Board has provided a 60-day comment period for this notice of proposal, therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that the rules proposed for readoption with amendments, repeals and new rules will have a positive impact upon members of the regulated community and will help to protect the health, safety and welfare of the citizens of New Jersey by identifying those individuals who are qualified and legally authorized to engage in the practice of pharmacy. These rules establish the requisite standards of licensure in the State and positively affect the regulated community by clarifying the varied aspects of pharmacy practice for the benefit of all licensees, permit holders, registrants and applicants for licensure, permits and registrations.

The proposed readoption of N.J.A.C. 13:39 continues accepted standards of pharmaceutical practice, and by so doing, provides licensees, permit holders, registrants and applicants a clear and comprehensive set of rules to guide them in their professional practice. Applicants for licensure or registration will benefit by having a set of rules that govern the manner in which they may qualify for licensure or registration. Licensees and registrants will also benefit from the rules proposed for readoption as a result of the uniform standards that will be applied throughout the profession. Permit holders will benefit by having clear and comprehensive standards that govern the operation and maintenance of permitted facilities, whether they be retail, institutional or nuclear pharmacies.

The Board also believes that the rules proposed for readoption will have a positive impact upon the general public by continuing to safeguard public health and safety, through the maintenance of professional practice standards that will enable licensees and permit holders to provide the highest quality professional service in the dispensing of medications.

Moreover, the Board believes that the proposed amendments to N.J.A.C. 13:39 and the proposed new rules will have a positive impact upon the licensed community and upon the consumers they serve. The Board believes that proposed new rule N.J.A.C. 13:39-1.7 will have a positive impact upon applicants for permits, licenses or registrations by encouraging applicants to complete the application process in a timely manner. Proposed amendments to N.J.A.C. 13:39-3A.2 will benefit licensees by providing direction about steps they must follow to obtain continuing education credit for attendance at a course that has not received prior Board approval.

The proposed amendments to N.J.A.C. 13:39-4.5 and 4.9, and proposed new rules N.J.A.C. 13:39-4.7 and 4.8, will have a positive impact upon pharmacy permit holders by clarifying the procedures that must be followed when a change in ownership, name, location or address occurs, or when a permit holder intends to remodel an existing pharmacy. The proposed amendments to N.J.A.C. 13:39-4.11 will have a positive impact upon consumers by clarifying that they have the right to obtain copies of their patient profile, in addition to copies of prescriptions, when a pharmacy ceases operation.

The proposed amendments to N.J.A.C. 13:39-5.7, 5.8, 5.9 and 5.10 will have a positive impact upon pharmacists and pharmacy permit holders by clarifying minimum storage and equipment requirements for retail pharmacies and institutional pharmacies filling prescriptions for outpatient use. The Board believes that the proposed amendments to N.J.A.C. 13:39-6.2 will have a positive impact upon health care facilities that are permitted as both institutional pharmacies and retail pharmacies. The proposed amendments will allow the facility to retain the services of one pharmacist to act as the pharmacist-in-charge of both the institutional pharmacy and the retail pharmacy, eliminating administrative redundancies.

The Board believes that proposed new rule N.J.A.C. 13:39-7.2, and the proposed amendments to N.J.A.C. 13:39-7.3, 7.4, 7.8 and 7.16 will have a positive impact upon pharmacists by clarifying what steps they must take to ensure that prescription information is appropriately documented and what procedures they must follow when dispensing an emergency supply of medications, when transferring prescriptions between pharmacies and when prescription medications are returned. The proposed amendments to N.J.A.C. 13:39-7.10 and 7.11 will help to clarify a pharmacist's [page=140] obligations with respect to facsimile and electronically transmitted prescriptions. The Board believes that the proposed amendments to recodify portions of N.J.A.C. 13:39-7.19 into proposed new rules N.J.A.C. 13:39-7.20 and 7.21 will have a positive impact upon pharmacists by making a pharmacist's responsibilities with respect to the maintaining patient profile records, conducting drug utilization review and offering patient counseling, easier to understand and follow.

The Board believes that the proposed amendments to N.J.A.C. 13:39-9.10, 9.11, 9.12, 9.15, 9.23 and 9.27 will have a positive impact upon members of the regulated community by helping to clarify the responsibilities and obligations of institutional pharmacies and their pharmacists with respect to dispensing medications in health care facilities, oral orders, drug labeling and the use of facsimile or electronically transmitted prescriptions. The Board also believes that the proposed amendments to N.J.A.C. 13:39-10.3 and 10.4 will have a positive impact upon pharmacies that utilize automated medication systems by clarifying the steps the pharmacy must take to begin using the system, including conducting self inspection of the system and identifying quality control measures designed to ensure the accuracy of the final dispensed medication.

Economic Impact

The Board anticipates that the rules proposed for readoption with amendments, repeals and new rules will not impose any significant new costs upon licensees, permit holders, registrants, applicants or consumers. The proposed readoption of the existing rules will continue the economic impact that the rules have had on such persons for the past five years.

The proposed readoption of the Board's fee schedule at N.J.A.C. 13:39-1.3 will continue to have an economic impact on licensees, registrants and permit holders and upon all applicants to the extent that they will be required to remit the fees set forth in the rule. The Board notes that the proposed deletion of the $ 60.00 yearly fee for distribution of Board minutes and agenda may have a positive impact upon persons who have remitted this fee in the past. Such information is now available without charge from the Board's website. The proposed amendments to N.J.A.C. 13:39-1.4 may have an economic impact upon licensees, registrants or permit holders required to remit penalties to the Board. The proposed amendments will provide licensees, registrants and permit holders with additional time to submit such penalties. Proposed new rule N.J.A.C. 13:39-1.7 may have an economic impact upon any applicant for licensure, registration or permit who fails to complete the application process within two years, resulting in the Board administratively closing the application. Such applicants will be required to reapply to the Board, and must resubmit all required documentation and application fees.

The proposed readoption of the application requirements in Subchapter 2, for those applying for initial licensure as a pharmacist, and in Subchapter 2A, for those applying for licensure as a pharmacist by reciprocity, may have an economic impact on such applicants, to the extent that they incur costs associated with obtaining the required education and experience, passing the required licensure examinations, and submitting the required documentation to substantiate satisfaction of the requirements in the rules. In addition, applicants for initial and reciprocal licensure may incur costs associated with submitting their fingerprints for the required criminal history records check.

The proposed readoption of N.J.A.C. 13:39-3.2, 3.3, 3.4 and 3.5 may have an economic impact upon licensed pharmacists, to the extent that pharmacists may incur costs associated with submitting the required documentation associated with obtaining a replacement license, changing their name and/or address, or obtaining a verification of licensure. The proposed readoption of N.J.A.C. 13:39-3.7 may have an economic impact upon licensed pharmacists to the extent that licensees who fail to comply with the renewal requirements set forth in the rule must pay late fees. The proposed readoption of N.J.A.C. 13:39-3.8 also may have an economic impact on licensed pharmacists who fail to renew their licenses to the extent that they may incur costs associated with submitting the documentation and fees required to reinstate a suspended license. These licensees may also incur costs to satisfy the competency requirements set forth in the rules. The proposed readoption of N.J.A.C. 13:39-3.9, concerning inactive licensure status, may have an economic impact upon licensees who choose to renew their licenses with the inactive designation. These licensees may incur costs associated with completing requisite continuing education requirements if they wish to resume active practice.

The proposed readoption with amendments of the continuing education requirements set forth in Subchapter 3A may continue to have an economic impact upon licensed pharmacists. Licensees must obtain the required number of continuing education credit hours in each biennial renewal period in order to maintain their licenses. Licensees may also incur administrative costs in maintaining continuing education records as required under the rules.

The proposed readoption of N.J.A.C. 13:39-4.1 may have an economic impact upon applicants for pharmacy permits to the extent that applicants and permit holders incur costs associated with submitting the required documentation and fees necessary to substantiate satisfaction of the requirements in the rule. The proposed readoption of N.J.A.C. 13:39-4.2 may also have an economic impact upon pharmacy permit holders who will be required to remit annual renewal fees in order to maintain their pharmacy permits. In addition, the proposed readoption of N.J.A.C. 13:39-4.4, 4.5, 4.6, 4.7, 4.9 and 4.13, and proposed new rule N.J.A.C. 13:39-4.8 may have an economic impact upon permit holders to the extent that they incur costs associated with submitting the documentation necessary to substantiate compliance with the Board's requirements concerning changes in ownership, name, address or location, for remodeling, or to obtain a replacement permit. Permit holders may also incur costs associated with making a pharmacy's records available to consumers upon a pharmacy's permanent closing under N.J.A.C. 13:39-4.11, and in ensuring that the security of the pharmacy building and its medication supply are maintained consistent with the requirements set forth in N.J.A.C. 13:39-4.15.

The proposed readoption of N.J.A.C. 13:39-4.19 may have an economic impact upon pharmacy permit holders wishing to engage in central prescription handling. Such permit holders may incur costs associated with submitting the documentation and fees required under N.J.A.C. 13:39-4.19 for Board approval to commence such operations. The proposed readoption of N.J.A.C. 13:39-4.20 may have an economic impact upon out-of-State pharmacies wishing to register with the Board in order to dispense medications in New Jersey to the extent that such pharmacies may incur costs associated with submitting the application and fees required under the rule. The proposed readoption of N.J.A.C. 13:39-4.21 may have an economic impact upon pharmacy permit holders and pharmacists who wish to offer pharmacist-provided immunizations. Permit holders may incur costs associated with satisfying the administrative requirements of the rule, and pharmacists may incur costs associated with obtaining the training necessary for Board approval to provide this service.

The proposed readoption with amendments of the rules in Subchapter 5 may have an economic impact upon pharmacy permit holders who may incur costs associated with ensuring that the minimum storage, equipment and facility requirements set forth in the rules are satisfied.

The Board believes that the proposed amendment to N.J.A.C. 13:39-6.2 may have an economic impact upon some health care facilities to the extent that facilities that possess both an institutional and retail pharmacy permit may now retain the services of one pharmacist to act as the pharmacist-in-charge of both pharmacies. The proposed readoption of N.J.A.C. 13:39-6.6 may have an economic impact upon applicants for registration as pharmacy technicians to the extent that applicants may incur costs associated with submitting the documentation required for registration, including undergoing a criminal history background check. In addition, the proposed readoption of N.J.A.C. 13:39-6.7 through 6.15 may have an economic impact upon individuals registered as pharmacy technicians. Such persons may incur costs associated with submitting the documentation necessary to obtain a replacement license, change his or her name and/or address or obtain a verification of licensure. Pharmacy technicians may also incur costs associated with registration renewal, including submission of late fees if they fail to renew in a timely manner and reinstatement fees if they seek to return to practice following a registration suspension.

Pharmacy permit holders may be economically impacted as a result of the proposed readoption with amendments of the rules in Subchapter 7, as well as proposed new rules N.J.A.C. 13:39-7.2, 7.20 and 7.21, to the [page=141] extent that they incur costs associated with maintaining and dispensing medications, and maintaining prescription and patient profile records, consistent with the requirements in the rules.

The proposed readoption with amendments of the rules in Subchapter 9 may have an economic impact upon institutional pharmacy permit holders, to the extent that such permit holders incur costs associated with maintaining and dispensing medications, maintaining medication records and security protocols and with ensuring that such pharmacies contain the minimum equipment and facilities set forth in the rules.

The proposed readoption of the rules in Subchapter 10 with amendments may have an economic impact upon permit holders desiring to utilize automated medication systems. Permit holders may incur costs associated with submitted the required documentation specified in the rules, as well as costs associated with ensuring that the automated medication system utilized comports with the requirements of the subchapter. Permit holders may also incur costs associated with creating and maintaining programs for quality assurance, recovery and preventative maintenance.

The proposed readoption of the rules in Subchapter 11 may have an economic impact upon pharmacies engaging in the compounding of sterile and non-sterile preparations. Such pharmacies may incur costs to ensure that the minimum environmental controls, facility and equipment requirements outlined in the rules are satisfied. Such pharmacies may also incur costs to ensure compliance with the documentation and record retention requirements imposed under the rules.

The proposed readoption of the rules in Subchapter 12 may have an economic impact upon pharmacies engaging in radiopharmaceutical services. These pharmacies may incur costs to ensure compliance with the minimum equipment and facility requirements set forth in the rules.

The Board believes that any costs that may be borne by members of the regulated community as a result of the rules proposed for readoption with amendments, repeals and new rules will be outweighed by the benefit to consumers in ensuring that pharmaceutical services are provided by qualified professionals consistent with the professional practice and facility standards delineated in the rules.

Federal Standards Statement

A Federal standards analysis is not required because the rules proposed for readoption with amendments, repeals and new rules are governed by N.J.S.A. 45:14-40 et seq., and are not subject to any Federal standards or requirements. Although the rules in N.J.A.C. 13:39 are not subject to any mandatory Federal requirements or standards, where deemed appropriate, the Board has incorporated Federal standards. Specifically, the Board notes that the requirements for the transmission of prescriptions for controlled substances set forth at N.J.A.C. 13:39-4.19, 7.8, 7.10, 7.11 and 9.27 are consistent with the Federal Drug Enforcement Administration (DEA) standards articulated at 21 CFR 1306.11, 1306.21 and 1306.25. In addition, record retention requirements for controlled dangerous substance prescriptions set forth in N.J.A.C. 13:39-5.8 and 7.6 are consistent with DEA standards set forth in 21 CFR 1306.26 and 1304.04. Moreover, pharmacies dispensing investigational new drugs under N.J.A.C. 13:39-7.5 and 9.10 must comply with Federal Department of Health and Human Services regulations set forth at 45 CFR Part 46. In addition, all pharmacies and pharmacy personnel must comply with all Federal laws, rules and regulations governing the practice of pharmacy pursuant to N.J.A.C. 13:39-6.2(f)9.

Jobs Impact

The Board does not anticipate that the rules proposed for readoption with amendments, repeals and new rules will result in an increase or decrease in the number of jobs in the State.

Agriculture Impact Statement

The Board does not believe that the rules proposed for readoption with amendments, repeals and new rules will have any impact upon the agriculture industry in the State.

Regulatory Flexibility Analysis

Currently, the Board licenses approximately 12,741 pharmacists, registers approximately 11,300 pharmacy technicians and issues permits to approximately 1,984 pharmacies. If Board licensees, registrants and permit holders are considered "small businesses," within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The rules proposed for readoption with amendments, repeals and new rules will impose various reporting, recordkeeping and compliance requirements upon licensees, registrants and permit holders. These requirements are discussed in the Summary above.

No additional professional services will be needed to comply with the rules proposed for readoption with amendments, repeals and new rules. In addition, the Board does not believe that there will be any significant, additional economic impact upon pharmacists, pharmacy technicians and pharmacy permit holders as a result of the rules proposed for readoption with amendments, repeals and new rules. The costs of compliance with the rules proposed for readoption with amendments, repeals and new rules are discussed in the Economic Impact above. The Board believes that the rules proposed for readoption with amendments, repeals and new rules should be uniformly applied to all licensees, registrants and permit holders in order to ensure the health, safety and welfare of the general public in the provision of pharmaceutical services. Therefore, no differing compliance requirements for any licensees, registrants or permit holders are provided based upon the size of the business, other than distinctions reflected with respect to the type of pharmacy being operated.

Smart Growth Impact

The Board does not believe that the proposed the rules proposed for readoption with amendments, repeals and new rules will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The rules proposed for readoption with amendments, repeals and proposed new rules will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the rules proposed for readoption with amendments, repeals and new rules concern the practice of pharmacy.

Smart Growth Development Impact

The rules proposed for readoption with amendments, repeals and proposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the rules proposed for readoption with amendments, repeals and new rules concern the practice of pharmacy.

Full text of the rules proposed for readoption may be found in the New Jersey Administrative Code at N.J.A.C. 13:39.

Full text of the rules proposed for repeal may be found in the New Jersey Administrative Code at N.J.A.C. 13:39-4.7, 5.9, 5.10, 7.2, 9.7 and 9.9.

Full text of the proposed amendments and new rules follows (additions indicated in boldface thus ; deletions indicated in brackets [thus]):

SUBCHAPTER 1. GENERAL PROVISIONS

13:39-1.1 Purpose and scope

(a) This chapter is promulgated by the New Jersey State Board of Pharmacy. The rules contained in this chapter implement the provisions of the New Jersey Pharmacy Practice Act, N.J.S.A. 45:14-[1] 40 et seq. , and regulate the practice of pharmacy within the State of New Jersey .

(b) This chapter shall apply to all [registered] pharmacies[,] ; pharmacists[,] ; [pharmacist applicants,] applicants for permits, licensure or registration; interns[,] ; externs[,] ; pharmacy technicians ; and anyone within the jurisdiction of the Board of Pharmacy.

13:39-1.2 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.

. . .

["Authorized prescriber" means a licensed practitioner who is authorized by law to write prescriptions and/or medication orders.]

[page=142] . . .

["Compounding" means the act of preparing pharmaceutical components into medications, pursuant to an authorized prescriber's prescription or medication order, including, but not limited to prescription compounding, and intravenous admixture preparation.]

"Compounding" means the preparation, mixing, assembling, packaging and labeling of a drug or device as the result of a practitioner's prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

. . .

"Dispense or dispensing" means the procedure entailing the interpretation of [an authorized prescriber's] a practitioner's prescription or medication order for a drug , biological or device, and , pursuant to that order, the proper selection, measuring, compounding, labeling[,] and [packing] packaging in a proper container for the subsequent administration to, or use by, a patient . The act of dispensing shall include all necessary consultation by the pharmacist.

"Drug or [medicine] medication " means:

1.-4. (No change.)

"Immediate personal supervision" means that the [registered] pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, [and] the finished label and the accuracy and appropriateness of the actions of pharmacy technicians, interns and externs .

"Legend drug or device" means any drug or device that:

1. (No change.)

2. Requires a prescription or order by [an authorized prescriber] a practitioner .

["Licensed practitioner" means a duly licensed physician, dentist, optometrist, veterinarian, certified nurse midwife, nurse practitioner/clinical nurse specialist or physician assistant, or other health care practitioner licensed or approved to write prescriptions intended for the treatment or prevention of disease, as set forth in N.J.S.A. 45:14-14.]

"Pharmaceutical services" means all services provided by a [registered] pharmacist. These services shall be concerned with, but not limited to: interpreting the prescription or medication order; selecting, preparing, compounding, packaging, [labelling] labeling , distributing and dispensing prescribed drugs; the proper and safe storage of drugs; the monitoring of drug therapy; the reporting and recording of adverse drug reactions and the provision of appropriate drug information; teaching and [counselling] counseling on the proper and safe use of drugs and medications.

"Pharmacist" means an individual holding an active license to engage in the practice of pharmacy in this State.

"Pharmacy" means a location permitted by the Board to engage in the practice of pharmacy in this State.

"Pharmacy technician" means an individual [employed by a pharmacy whose responsibilities do not require professional judgment in the preparation and distribution of medications] registered with the Board and who works under the immediate personal supervision of a pharmacist in compliance with N.J.A.C. 13:39-6.15. For purposes of this definition, interns, externs, cashiers, stocking and clerical help are not pharmacy technicians.

"Practitioner" means an individual currently licensed, registered or otherwise authorized by the jurisdiction in which the individual practices to administer or prescribe drugs and/or devices in the course of professional practice.

. . .

"Professional judgment" means judiciousness and discretion based upon thorough knowledge and sound application of the specialized body of knowledge peculiar to the practice of pharmacy, and an understanding of the relationship of this knowledge and its application to the well-being of the patient and to the judgment of the [prescriber] practitioner .

["Registered pharmacist" or "pharmacist" means a person whose license is in good standing for the current license renewal period.]

13:39-1.3 Fee schedule

(a) The following fees shall be charged by the Board:

1. For pharmacists as follows:

i.-xii. (No change.)

[xiii. Yearly fee for distribution of minutes and agenda 60.00.]

2.-5. (No change.)

13:39-1.4 Payment of penalties

(a) Any penalties levied by the Board shall be paid within [10 calendar] 15 business days of the finalization of a penalty letter or final order of the Board unless otherwise prescribed by statute or terms of a final order.

(b) (No change.)

13:39-1.7 Failure to complete application process

If an applicant for a permit, license or registration issued pursuant to the requirements of this chapter fails to complete the application process within two years of the date of initial application, the Board shall administratively

administratively close the application. Following such action, an applicant making reapplication to the Board shall resubmit all required documentation and the applicable application fee set forth at N.J.A.C. 13:39-1.3.

SUBCHAPTER 2. REQUIREMENTS FOR INITIAL LICENSURE

13:39-2.6 Internship and externship practical experience requirements

(a) The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

. . .

"Intern preceptor" means a pharmacist [registered] licensed in this State who assumes the responsibility to supervise and provide instructional training to a pharmacy intern as set forth in (f) below.

. . .

(b) (No change.)

(c) A pharmacist who wishes to be an intern preceptor shall apply to the Board and shall furnish evidence that he or she:

1. Has been [registered] licensed and employed on a full-time basis as a pharmacist in the area of practice in which he or she is to be engaged as a preceptor [on a full-time basis] for at least two years immediately preceding the date of application and is currently engaged in the practice of pharmacy in the State of New Jersey; and

2. (No change.)

(d)-(f) (No change.)

SUBCHAPTER 3. [REGISTERED] PHARMACIST REQUIREMENTS

13:39-3.1 Authorization to practice; display of license

(a) (No change.)

(b) Upon issuance of a license, the current biennial renewal license shall be conspicuously displayed in the [registered] pharmacist's principal place of employment.

(c) A [registered] pharmacist who is employed by more than one [licensed] pharmacy in the State shall maintain the wallet-sized license issued by the Board on his or her person when he or she is working at a location where his or her current biennial renewal license is not on display.

13:39-3.3 Change of name

If a [registered] pharmacist legally changes the name under which he or she engages in the practice of pharmacy, the pharmacist shall notify the Board within 30 days of such change. The [registered] pharmacist shall submit original proof of the change of name or a certified copy of the court order or marriage certificate , which shall be retained by the Board. When a replacement license is issued, the initial license shall be [page=143] returned for cancellation and the pharmacist shall remit the required fee as prescribed in N.J.A.C. 13:39-1.3.

13:39-3.4 Change of address of record; service of process

(a) A [registered] pharmacist shall notify the Board in writing of any change in his or her address of record within 30 days.

(b) Failure to notify the Board of any change in a [registered] pharmacist's address of record pursuant to (a) above may result in disciplinary action in accordance with N.J.S.A. 45:1-21(h) and N.J.A.C. 13:45C-1.3, and the imposition of penalties set forth in N.J.S.A. 45:1-25.

(c) Service of any administrative complaint or other Board-initiated process at a [registered] pharmacist's address of record shall be deemed adequate notice for the purposes of N.J.A.C. 1:1-7.1 and the commencement of any disciplinary proceedings.

13:39-3.5 Verification of licensure

A verification that the license of a [registered] pharmacist is in good standing shall be supplied by the Board upon written request and upon payment of the fee set forth in N.J.A.C. 13:39-1.3.

SUBCHAPTER 3A. CONTINUING EDUCATION

13:39-3A.1 Continuing education credit hour requirements

(a) Each applicant for biennial license renewal shall complete a minimum of 30 credits of continuing education during the preceding biennial period, except that the Board shall not require completion of continuing education credits for an applicant's initial license renewal. At least 10 of the continuing education credits shall be obtained through didactic instruction. For purposes of this [paragraph] subsection , "didactic instruction" means in-person instruction and may include telephonic or electronic instruction that is interactive, but shall not include videotaped instruction. [For the biennial renewal period commencing May 2005 and thereafter, at] At least three continuing education credits shall be obtained in pharmacy law applicable to the practice of pharmacy in New Jersey .

(b) (No change.)

13:39-3A.2 Criteria for continuing education credit

(a) (No change.)

(b) A licensee seeking credit for attendance at a program or course that is not offered by an American Council of Pharmaceutical Education approved provider and that has not been approved by the Board pursuant to N.J.A.C. 13:39-3A.6, shall submit for Board review and approval, on a form provided by the Board, information similar to that which is required to be submitted by a sponsor pursuant to N.J.A.C. 13:39-3A.6(a), the continuing education review fee set forth at N.J.A.C. 13:39-1.3 and the verification of attendance.

13:39-3A.4 Continuing education credit hour reporting procedure

(a) A licensee shall specify on his or her application for biennial license renewal that the required number of continuing education credits has been completed. Falsification of any information contained in the renewal application may result in an appearance before the Board and the assessment of penalties and/or license suspension pursuant to N.J.S.A. 45:1-21 et seq.

(b)-(c) (No change.)

SUBCHAPTER 4. PHARMACY PERMIT REQUIREMENTS

13:39-4.1 New pharmacies; pharmacy departments; eligibility and application

(a)-(b) (No change.)

(c) The permit application shall [bear] include the exact trade name (s) , if any; the corporate names, if any; the name and addresses of the owners and operators, if a sole proprietorship, partnership, limited liability partnership or limited liability company; the names and addresses of all officers and stockholders and the names and addresses of all principals duly licensed to write prescriptions if the pharmacy is not a publicly traded corporation; and the names and addresses of the officers, if a publicly traded corporation.

(d) The permit application shall include the name of the [registered] pharmacist-in-charge who shall be a [registered] pharmacist in good standing in the State of New Jersey .

(e)-(h) (No change.)

13:39-4.2 Issuance of permits; permit renewals

(a) All permits shall be issued by the Board in the name of the pharmacy [or other licensed establishment] for the operation of which the permit is issued.

(b)-(c) (No change.)

13:39-4.3 Display of permits

[A] The current permit issued by the Board for the operation of a pharmacy [or other licensed establishment] shall be conspicuously displayed.

13:39-4.5 Change of ownership; asset acquisition

[(a) Whenever there is any change in ownership of the business entity holding a permit to operate a pharmacy, the new ownership of such entity shall apply for a new permit on a form prescribed and furnished by the Board and pay a fee pursuant to N.J.A.C. 13:39-1.3. The new owner(s) of such entity shall not operate a pharmacy under an existing permit for more than 60 days following a change in ownership. Before a permit may be issued to the new owner(s) of the business entity, the Board shall inspect and approve the fixtures, equipment and inventory of the pharmacy to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances, and shall require evidence of the transfer of ownership and an inventory of controlled substances being transferred to the new owner(s).]

(a) When there is a change in the ownership of the business entity holding a permit to operate a pharmacy, the following requirements shall be satisfied, as applicable:

1. When a complete change in ownership occurs and none of the current owners retains any ownership interest, the new owner(s) shall, prior to, or within 10 business days of, such change, submit to the Board a new permit application pursuant to N.J.A.C. 13:39-4.1, the new permit application fee set forth in N.J.A.C. 13:39-1.3, and an inventory of the pharmacy's controlled substances. A new pharmacy permit number shall be issued upon request;

2. When a reallocation of ownership interests occurs among existing owners, the owners shall, prior to, or within 10 business days of, such change, submit to the Board an affidavit explaining the asset reallocation. A new pharmacy permit number shall not be issued upon a reallocation of business assets among existing owners; or

3. When the existing ownership is changed through the addition of a new owner(s) or the subtraction of an existing owner, the owners shall, prior to, or within 10 business days of, the addition of the new owner(s), submit to the Board a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. A new pharmacy permit number shall be issued upon request.

(b)-(c) (No change.)

13:39-4.7 Change of location and/or address of licensed premises

(a) When a pharmacy permit holder intends to change the physical location and address of the permitted premises, the permit holder shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit. If the change in location and address will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at N.J.A.C. 13:39-4.10(c) and (d). The permit holder shall submit a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. The Board shall issue an amended pharmacy permit reflecting the new location and address of the pharmacy. Before an amended permit may be issued to the permit holder for the new location, the Board shall inspect and approve the premises, fixtures, equipment and inventory of the new location to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances. The permit holder shall ensure that the prescription and profile records from the pharmacy's previous location and address are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the location and address change.

[page=144] (b) Whenever there is a change in a pharmacy's address but no change in the physical location of the licensed premises, the permit holder shall, within 10 business days of the change in address, submit an affidavit to the Board explaining such change.

13:39-4.8 Remodeling of licensed premises

(a) Prior to the remodeling of a pharmacy or pharmacy department, where such remodeling entails a change within the premises of the location or size of the prescription area, or a change in the dimensions of the licensed premises, the permit holder shall notify the Board at least 30 days in advance on a form prescribed by the Board. The pharmacy permit holder shall submit plans for the continuation of operations during the remodeling process which the Board shall review and approve, and the anticipated date of completion. The permit holder shall ensure compliance with all requirements set forth in this chapter while services continue during the remodeling process, and if the remodeling will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at N.J.A.C. 13:39-4.12(c) and (d).

(b) The pharmacy permit holder shall notify the Board upon completion of the remodeling process. Within 60 days of the completion of the remodeling, the Board shall inspect and approve the premises, fixtures, equipment and inventory of the remodeled pharmacy to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances.

13:39-[4.12] 4.9 Change of name

[(a) A change in the name of a pharmacy or other Board-licensed establishment shall be made upon the submission to the Board for approval of the new name and of prescription labels bearing the new name.]

(a) When a pharmacy permit holder intends to change the name of the pharmacy, the permit holder shall apply to the Board, at least 30 days prior to such change, for an amended permit. The permit holder shall submit a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. The Board shall issue an amended pharmacy permit reflecting the new name of the pharmacy.

(b) (No change.)

(c) If a change in pharmacy name is associated with a change in ownership, the permit holder shall ensure that the requirements set forth in N.J.A.C. 13:39-4.5 are satisfied.

13:39-[4.8] 4.10 Discontinued pharmacies

(a) Whenever a pharmacy is to be discontinued and closed for any reason, including suspension or retirement of the permit holder, sale or insolvency, the permit holder shall immediately send written notification of the anticipated closing to the State Board of Pharmacy, the Office of Drug Control and the Drug Enforcement Administration at least 15 days prior to the anticipated closing date. Whenever a pharmacy is to be discontinued and closed as a result of an unanticipated occurrence, such as the death of the permit holder, the permit holder's representative shall send written notification to the Board, the Office of Drug Control and the Drug Enforcement Administration, as soon as possible prior to the actual closing date. All medications, including prescription legend and controlled drugs, should be transferred to the holder of a current pharmacy permit; a wholesaler; a reverse distributor; and/or a manufacturer. All medications not properly transferred shall remain on the [licensed] pharmacy premises with all licenses and registrations in effect until such medications are disposed of in the manner prescribed by the Board, the Office of Drug Control and/or the Drug Enforcement Administration.

(b) (No change.)

13:39-[4.9] 4.11 Availability of records upon termination of business

(a) When a pharmacy ceases operation as the result of a suspension, retirement or death of the owner, sale or other cause including insolvency, the [licensee] permit holder , or the one responsible for supervising the disposition of the practice, shall make every effort to notify patrons that they have the right to obtain copies of currently valid prescriptions and/or copies of their patient profile and the location of the prescriptions and patient profile for a one-year period following notice, using all of the following methods:

1. (No change.)

2. Publication, once weekly for two successive weeks in a newspaper whose circulation encompasses the [major] geographic area [of the licensee's former practice] in which the pharmacy is located , of a notice advising patrons that they have the right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile for a one-year period following publication; and

3. A sign placed in the pharmacy location informing the patrons that they have the right to obtain copies of their prescriptions and/or patient profile, and the location of the prescriptions and patient profile.

13:39-[4.10] 4.12 Business hours; unauthorized closing

(a) (No change.)

(b) If any permanent changes are made in the opening or closing hours of a pharmacy [or other Board-licensed establishment], the Board office shall be notified in writing of these changes within 30 days.

(c) A notice shall be conspicuously displayed on the exterior of any pharmacy [or other Board-licensed establishment] indicating any temporary changes in the opening or closing hours of the pharmacy [or establishment], or indicating a temporary closing of the pharmacy [or establishment] whenever such changes occur.

(d) Any temporary closing of a pharmacy [or other Board-licensed establishment] for more than 48 hours shall be reported to and approved by the Board. Notification to the Board shall include contingency plans for accessing patient records. Any temporary closing of more than 48 hours without prior Board approval shall result in the pharmacy being deemed a discontinued pharmacy requiring compliance with the requirements of N.J.A.C. 13:39-[4.8] 4.10 and 4.11 .

13:39-[4.11] 4.13 (No change in text.)

( Agency Note: N.J.A.C. 13:39-4.12 is proposed for recodification with amendments as N.J.A.C. 13:39-4.9.)

13:39-[4.13] 4.14 Reproduction of permits

(a) Any permit issued by the Board for the operation of a pharmacy [or other board-licensed establishment] may [only] be [photocopied] copied only for State agencies and other business entities with whom the permit holder does pharmacy related business.

(b) (No change.)

13:39-[4.14] 4.15 Security of pharmacies and pharmacy departments

(a) The [registered] pharmacist(s) on duty in all pharmacies, including pharmacy departments, shall be responsible for:

1.-2. (No change.)

3. Reporting all thefts or diversions of prescription legend drugs and devices and controlled substances, and any significant loss of prescription legend drugs and devices and controlled substances, to the [registered] pharmacist-in-charge [and/or] or the pharmacy permit holder upon discovery. When determining whether a loss of prescription legend drugs or devices or controlled substances is significant, the following factors shall be considered, consistent with 21 CFR 1301.74(c):

i.-vi. (No change.)

(b) The holder of a pharmacy or pharmacy department permit and the [registered] pharmacist-in-charge of the pharmacy or pharmacy department shall ensure that:

1. All entrances to the pharmacy or pharmacy department are capable of being locked and are connected to a monitored security system that transmits an audible, visual or electronic signal warning of intrusion. The security system shall be equipped with a back-up mechanism to ensure notification or continued operation if the security system is tampered with or is disabled. Only the [registered] pharmacist-in-charge [of the permitted premises or the pharmacy department] shall be responsible for the security of the keys and the security system access code to the pharmacy or pharmacy department;

2. If a theft or diversion of prescription legend drugs or devices or controlled substances, or a significant loss of prescription legend drugs or devices or controlled substances, as delineated in (a) above, is reported to the [registered] pharmacist-in-charge, the [registered] pharmacist-in-charge shall notify the holder of the pharmacy or pharmacy department [page=145] permit of such report. The [registered] pharmacist-in-charge and the holder of the pharmacy or pharmacy department permit shall ensure that:

i.-ii. (No change.)

3.-4. (No change.)

(c) In addition to the requirements set forth in (b) above, the holder of a pharmacy department permit and the [registered] pharmacist-in-charge of the pharmacy department shall also ensure that:

1.-3. (No change.)

4. The telephone number of the [registered] pharmacist-in-charge is available in the office of the manager of the establishment.

(d) (No change.)

13:39-[4.15] 4.16 (No change in text.)

13:39-[4.16] 4.17 Steering prohibited

It shall be unlawful for a pharmacy permit holder to enter into an arrangement with a [health care practitioner who is licensed to issue prescriptions] practitioner for the purpose of directing or diverting patients to or from a specified pharmacy for the filling of prescriptions or restraining in any way a patient's freedom of choice to select a pharmacy.

13:39-[4.17] 4.18 Responsibilities of permit holders

(a) (No change.)

(b) Any permit holder may be held liable for violations of the New Jersey Pharmacy Practice Act, N.J.S.A. 45:14-[1] 40 et seq., and the rules in this chapter and may be subject to disciplinary action.

13:39-[4.18] 4.19 Procedures for centralized prescription handling

(a)-(b) (No change.)

(c) The following pharmacies may engage in central prescription handling: an intake or originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a dispensing pharmacy. The four component functions of handling a prescription shall be performed by the following pharmacies:

1. An intake or originating pharmacy, which is a [licensed] pharmacy that received the patient's or prescribing practitioner's request to fill or refill a prescription. A central processing pharmacy or a central fill pharmacy, as delineated in (c)2 and 3 below, may be considered the intake or originating pharmacy if the prescription was transmitted by the prescribing practitioner directly to the centralized pharmacy as provided in N.J.A.C. 13:39-7.10 and 7.11 or if the patient requested the refill from that pharmacy;

2. A central processing pharmacy, which is a [licensed] pharmacy that engages in prescription review by performing functions that may include, but are not limited to, data entry, prospective drug review, refill authorizations, interventions, patient counseling, claims submission, claims resolution and adjudication;

3. A central fill pharmacy, which is a [licensed] pharmacy engaging in central prescription handling by filling and/or refilling prescriptions , which includes the preparation and packaging of the medication; and

4. A dispensing pharmacy, which is a [licensed] pharmacy that receives the processed prescription and/or the filled or refilled prescription for dispensing to the patient or to the patient's authorized representative and [which] that offers patient counseling regarding the dispensed medication.

(d) Two or more of the [licensed] pharmacies delineated in (c) above may engage in central prescription handling provided:

1.-3. (No change.)

4. The dispensed prescription for any product bears a permanently affixed label with at least the following information:

i. The brand name , or if a generic , the brand name[,] and [if] the name of the generic[, the name of the manufacturer] in the following form, with the generic name and brand name inserted as appropriate:

"--------- Generic for ---------" ;

ii.-vi. (No change.)

vii. The [prescriber] practitioner name;

viii.-xii. (No change.)

5.-9. (No change.)

(e) A prescription for a controlled substance may be filled or refilled by pharmacies engaging in central prescription handling when permitted by law, consistent with Federal requirements set forth at 21 [C.F.R. ßß] CFR 1300 et seq.

13:39-[4.19] 4.20 Out-of-State pharmacy registration

(a)-(b) (No change.)

(c) An out-of-State pharmacy seeking to register with the Board shall submit a completed application for registration to the Board , which shall include the following:

1.-4. (No change.)

5. A letter of good standing from the state licensing authority in the state in which the licensed, permitted or registered out-of-State pharmacy is [licensed, permitted or registered] located ; and

6. (No change.)

(d)-(e) (No change.)

(f) An out-of-State pharmacy registered with the Board shall submit the information set forth in (c)1 though 5 above and the fee set forth in N.J.A.C. 13:39-1.3(a)4, if applicable, within 30 days of the following:

1.-4. (No change.)

5. A change in the [registered] pharmacist-in-charge.

(g)-(k) (No change.)

13:39-[4.20] 4.21 (No change in text.)

SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS

13:39-5.1 Purpose and scope

The rules in this subchapter shall apply to all retail pharmacies , [and] retail pharmacy departments [in the State] and all institutional pharmacies filling prescriptions for outpatient use . For purposes of this subchapter, "pharmacy" means a retail pharmacy , [or a] retail pharmacy department or an institutional pharmacy filling prescriptions for outpatient use .

13:39-5.3 Pharmacy signs

(a) (No change.)

(b) Pharmacies shall post the hours that the pharmacy is open and the name of the [registered] pharmacist-in-charge in plain view at all consumer entrances and consumer access points to the pharmacy, including drive-thru windows and drop-off boxes.

(c) In the case of a pharmacy department, the hours that the department is open and the name of the [registered] pharmacist-in-charge shall be posted in plain view at the entrance to the department and at all consumer entrances and consumer access points to the premises, including drive-thru windows and drop-off boxes. When the premises in which the pharmacy department is located maintains different hours of operation from the pharmacy department, all advertising, announcements, signs and statements indicating hours of operation and the presence of the pharmacy department shall clearly and distinctly indicate the hours that the pharmacy department is open.

13:39-5.7 [Storage and adequate stock] Adequate storage

There shall be sufficient shelf, drawer or cabinet space within the prescription area for proper storage of prescription drugs and chemicals and the minimum equipment required pursuant to N.J.A.C. 13:39-5.8. All prescription drugs and chemicals shall be maintained under adequate storage conditions, including proper lighting, ventilation and temperature control, as recommended by the drug manufacturer.

13:39-5.8 Minimum equipment and [facilities] supplies; cleanliness

(a) [The] All prescription areas shall contain the following minimum equipment and [facilities shall be required to be in every prescription area, and this equipment] supplies, which shall be stored , so as to be readily accessible [and shall be kept in a clean condition]:

1. An up-to-date, comprehensive pharmaceutical reference text(s) and suitable current reference texts encompassing the [general practice of pharmacy] pharmaceutical services provided by the pharmacy , drug interactions, drug product composition and patient counseling. Unabridged [computerized] electronic versions of [these] such reference texts shall be acceptable;

2. Over the counter Schedule V Record Book or an electronic recording system, as permitted by Federal law pursuant to 21 CFR [page=146] 1306.26 and 1304.04, to maintain all required information consistent with N.J.A.C. 8:65-7.19(a)5 , if Schedule V [medication is] controlled substances are sold without a prescription;

3.-4. (No change.)

[5. Class A prescription balance with a complete set of metric weights or equivalent electronic weighing device;

6. Volumetric devices capable of measuring 0.3 ml to 500 ml;

7. A glass mortar and pestle;

8. Glass funnels;

9. Stirring rods;]

5. Suitable volumetric devices;

[10.] 6. (No change in text.)

[11. Ointment tile or parchment paper;]

Recodify existing 12.-14. as 7.-9. (No change in text.)

[15.] 10. Auxiliary labels[, including poison labels];

[16. Suppository mold;]

[17.] 11. Two Drug Utilization Review Council Placards and the [current Drug Utilization Review Council Formulary; and] 29th edition of the list of "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book," incorporated herein by reference, as amended and supplemented, consistent with Department of Health and Senior Services rules set forth at N.J.A.C. 8:71-1. The Orange Book can be obtained by contacting the Superintendent of Documents, Government Printing Office, PO Box 371954, Pittsburgh, PA 15250-7954, (202) 512-1800 or toll free (866) 512-1800, and is available on-line at http://www.fda.gov/cder/orange/default.htm and at http://www.fda.gov/cder/ob/default.htm ;

[18.] 12. Assorted stock of prescription containers and child safety closures or caps[.] that meet United States Pharmacopoeia/National Formulary standards on light resistance and tightness; and

13. Copies of, or access to, current State statutes and rules relating to the practice of pharmacy.

(b) All prescription areas where non-sterile compounding is performed shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible:

1. Class A prescription balance with a complete set of metric weights or equivalent electronic weighing device;

2. A glass mortar and pestle;

3. Glass funnels;

4. Stirring rods;

5. Ointment tile or parchment paper; and

6. Suppository mold.

(c) The prescription area and all related equipment and supplies shall be kept in a clean, orderly and sanitary condition at all times.

13:39-[5.11] 5.9 Prescription balances, scales, weights and automatic counting devices

(a) All pharmacies shall have all balances, scales, weights and automatic counting devices inspected every 12 months by the Department of Weights and Measures of the municipality or county in which the pharmacy [or other Board-licensed establishment] is located, and such balances, scales, weights and automatic counting devices shall be properly sealed by the applicable authority.

(b) Counting trays or counting devices that meet the requirements of (a) above shall be used to count oral, solid drugs or medications.

13:39-[5.12] 5.10 Restriction on storage of prescription legend drugs and controlled dangerous substances

(a) (No change.)

(b) Prescription legend drugs, devices and controlled dangerous substances shall [only] be stored only in areas of the premises that are part of the [permitted] pharmacy or pharmacy department , except that in a health care facility, prescription legend drugs, devices and controlled dangerous substances shall be stored consistent with the requirements of N.J.A.C. 13:39-9.23 .

(c) Prescription legend drugs, devices and controlled dangerous substances that are received during hours the pharmacy or pharmacy department is closed shall be stored consistent with the requirements of N.J.A.C. 13:39-4.15(b)3.

SUBCHAPTER 6. [REGISTERED] PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL

13:39-6.2 [Registered pharmacist] Pharmacist -in-charge

(a) Every pharmacy shall name a pharmacist [licensed and] whose license is in good standing in New Jersey as the [registered] pharmacist-in-charge of the pharmacy. No pharmacy shall operate without a [registered] pharmacist-in-charge for longer than 30 days.

(b) Whenever the [registered] pharmacist-in-charge is absent from the pharmacy for more than 30 days, the [registered] pharmacist-in-charge and the permit holder shall notify the Board of the name of the [registered] pharmacist who shall act as the interim [registered] pharmacist-in-charge.

(c) A [registered] pharmacist shall not assume the responsibilities of a [registered] pharmacist-in-charge of more than one pharmacy or pharmacy department simultaneously , except as provided in (c)1 below .

1. If an area within a health care facility is permitted as both an institutional pharmacy and a retail pharmacy, the health care facility may employ one individual to act as the pharmacist-in-charge for both the institutional pharmacy and the retail pharmacy.

(d) Whenever there is a change of a [registered] pharmacist-in-charge of a pharmacy [or other Board-licensed establishment], an inventory of all controlled dangerous substances as defined in N.J.A.C. 8:65-10.1 through 10.5 shall be performed consistent with the requirements of N.J.A.C. 8:65-5.4 and 5.5.

(e) Whenever a [registered] pharmacist assumes or terminates the duties as a [registered] pharmacist-in-charge of a pharmacy [or other Board-licensed establishment], the [registered] pharmacist-in-charge and the permit holder shall so advise the Board in writing within 30 days by completing a form provided by the Board.

(f) A [registered] pharmacist-in-charge shall be a full-time employee, employed for a minimum of 35 hours per week and shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to supervise and ensure that:

[1. Adequate staffing is present to fulfill the needs of the pharmacy or pharmacy department;]

1. The pharmacy is staffed by sufficient, competent personnel in keeping with the size, scope and complexity of the pharmaceutical services provided by the pharmacy;

2.-8. (No change.)

9. The pharmacy and all pharmacy personnel provide pharmaceutical services in accordance with acceptable professional standards and comply with all Federal and State statutes, rules and regulations governing the practice of pharmacy.

13:39-6.3 Identification tag

All personnel working in the pharmacy , except personnel engaging in the compounding of sterile preparations consistent with the requirements of N.J.A.C. 13:39-11, shall wear an identification tag , which shall include at least the person's first name , first initial of their last name and job title. The identification tag of any employee in training shall reflect the status of the employee as a trainee.

13:39-6.5 Prescription handling by pharmacy externs, interns or pharmacy technicians

A pharmacy intern, extern or technician in any pharmacy may perform the component functions of prescription handling[, as defined] described in N.J.A.C. 13:39-4.18, consistent with the requirements of this chapter. On or after April 5, 2011, all steps performed by a pharmacy technician, intern or extern shall be documented in the pharmacy audit trail consistent with the requirements of N.J.A.C. 13:39-7.6 . [All entries to the audit trail shall be reviewed and approved by a pharmacist pursuant to N.J.A.C. 13:39-7.6. When one registered pharmacist is involved in the component functions of prescription handling, by either personally performing the functions or by reviewing the functions performed by technicians, interns or externs, the pharmacist shall be responsible for the accuracy and appropriateness of the filled prescription. When more than one pharmacist is involved in the component functions of prescription handling, each pharmacist shall be responsible for the accuracy and appropriateness of the component function he or she performed or that he or she reviewed and approved.]

[page=147] 13:39-6.6 Pharmacy technician registration and pharmacy technician applicants

(a)-(d) (No change.)

(e) If an applicant for registration as a pharmacy technician is being investigated for any alleged violation of the New Jersey Pharmacy Practice Act, N.J.S.A. 45:14-[1] 40 et seq., or the pharmacy laws, rules or regulations of any other jurisdiction, the Board in its discretion may deny the applicant the opportunity to register as a pharmacy technician.

(f) (No change.)

13:39-6.7 Authorization to practice as a pharmacy technician; display of registration

(a)-(b) (No change.)

(c) A registered pharmacy technician who is employed by more than one [licensed] pharmacy in the State shall maintain the wallet-sized registration issued by the Board on his or her person when he or she is working at a location where his or her current biennial renewal registration is not on display.

13:39-6.15 Pharmacy technician duties and pharmacist-technician ratios

(a) In addition to externs and interns, only pharmacy technicians and pharmacy technician applicants may assist the [registered] pharmacist in performing the following tasks:

1.-2. (No change.)

3. Label preparation; [and]

4. The counting, weighing, measuring, pouring and compounding of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system[.] ; and

[(b)] 5. [Pharmacy technicians and pharmacy technician applicants may accept] Accepting authorization from a patient for a prescription refill, or from a [physician] practitioner or his or her agent for a prescription renewal, provided that the prescription remains unchanged , consistent with (a)5i below:

i. The pharmacy technician or pharmacy technician applicant shall identify himself or herself as a pharmacy technician when accepting authorization from a [physician] practitioner or his or her agent. For purposes of this section, "prescription refill" means the dispensing of medications pursuant to a [prescriber's] practitioner's authorization provided on the original prescription. For purposes of this section, "prescription renewal" means the dispensing of medications pursuant to a practitioner's authorization to fill an existing prescription that has no refills remaining.

Recodify existing (c) and (d) as (b) and (c) (No change in text.)

[(e)] (d) Except as provided in [(f)] (e) below, a pharmacist shall not supervise more than two pharmacy technicians at any given time. The pharmacist shall provide immediate personal supervision, as defined in N.J.A.C. 13:39-1.2, of all pharmacy technicians he or she supervises. Those personnel who do computer processing of prescriptions are to be included in the 1 to 2 ratio. A registered pharmacy technician or a pharmacy technician applicant who is receiving in-service training, which shall not exceed 210 days, shall be excluded from the 1 to 2 ratio during such training. A pharmacist shall not supervise more than two persons receiving in-service training at the same time.

[(f)] (e) A pharmacy that employs a [registered] pharmacist to pharmacy technician ratio greater than 1:2 shall:

1. (No change.)

2. Ensure and document that all pharmacy technicians who are working when the ratio exceeds 1:2 have:

i.-ii. (No change.)

iii. Completed a program [which] that includes a testing component , which has been approved by the Board as satisfying the criteria set forth in [(g)] (f) below. Completion of a program with a Board-approved testing component shall qualify the pharmacy technician to work only for the specific pharmacy and/or corporation for which the pharmacy technician was employed when the training was obtained. If the pharmacy technician becomes employed by another pharmacy and/or corporation, the pharmacy technician shall be required to complete the new employer's training program;

3. (No change.)

4. Ensure that the duties assigned to any pharmacy technician do not exceed the established job descriptions, task protocols[,] and policies and procedures, nor involve any of the prohibited tasks in [(c)] (b) above;

5.-7. (No change.)

[(g)] (f) If the pharmacist to pharmacy technician ratio exceeds 1:2, the pharmacy shall maintain a policy and procedure manual with regard to pharmacy technicians , which shall include the following:

1.-12. (No change.)

13. Functions that may not be performed by pharmacy technicians, including at a minimum those functions listed in [(c)] (b) above; and

14. (No change.)

[(h)] (g) The pharmacist - in - charge shall review at least every two years and, if necessary, amend the policy and procedure manual. Documentation of the review shall be made available to the Board upon request.

[(i)] (h) When pharmacy technicians and pharmacy technician applicants are engaged in any permitted activities, the [registered] pharmacist(s) shall be responsible for all the activities of the pharmacy technicians and the pharmacy technician applicants.

SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS

13:39-7.1 Valid prescriptions[; out-of-State prescriptions]

(a) A pharmacist shall only fill a prescription issued by a practitioner licensed to [write] issue prescriptions in New Jersey and practicing in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank pursuant to N.J.S.A. 45:14-[14.4] 55 and N.J.A.C. 13:45A-27, except as provided in N.J.A.C. 13:39-7.10 and 7.11.

(b) A pharmacist shall fill a prescription issued by a [prescriber licensed to write] practitioner authorized to issue prescriptions in another state, territory or possession of the United States, including prescriptions issued at facilities within or outside of New Jersey that are regulated by the United States Department of Veterans Affairs and/or the Department of Defense. Such prescriptions shall be filled pursuant to New Jersey law. Such prescriptions shall not be required to be issued on a New Jersey Uniform Prescription Blank.

(c) (No change.)

13:39-7.2 Lack of information on original prescription

(a) If a practitioner fails to include on the original prescription any information that he or she is required to include pursuant to rules governing the practitioner's professional practice, including New Jersey Uniform Prescription Blanks rules set forth at N.J.A.C. 13:45A-27, the pharmacist shall obtain such information.

1. If the practitioner has failed to include directions for use and the practitioner cannot be contacted, the pharmacist shall indicate on the prescription label the words "use as directed" or "as ordered by the physician" or similar words to the same effect.

(b) All information required for a valid prescription shall be recorded on the prescription, or in the patient profile record system maintained pursuant to N.J.A.C. 13:39-7.19, or in the pharmacy's other manual or electronic files.

13:39-7.3 Authorization for renewal of prescriptions ; new prescriptions

(a) A prescription for medication or devices , which pursuant to State or Federal law may be sold, dispensed or furnished only upon prescription, shall not be renewed without specific authorization of the [prescriber] practitioner or the practitioner's authorized agent , and the prescription may not be filled or refilled after one year from the date [of] the original prescription was issued . A pharmacist obtaining authorization from a practitioner's authorized agent shall document the name and title of the agent.

1. Prescriptions marked "PRN" or other letters or words meaning refill as needed shall not be renewed beyond one year past the date [of] the original prescription was issued .

(b) When the renewals listed on the original prescription have been depleted, no additional renewals may be added to the original prescription. For additional dispensing, a new prescription must be authorized by the [prescriber as provided in N.J.S.A. 45:14-14, which [page=148] must be reduced to writing by the pharmacist and entered into either a manual or into the electronic data processing system as a new prescription. A new prescription shall be generated and the original prescription shall remain in the prescription file in chronological order.] practitioner.

(c) Prescription information obtained from a practitioner shall be documented at the time of receipt as a new prescription in hard copy form or by direct entry into the electronic prescription records system.

13:39-7.4 Emergency dispensing

(a) [In] Except as provided in (b) below, in the absence of a current, valid prescription, a pharmacist may dispense an emergency supply (no more than a 72-hour quantity) of a chronic maintenance drug [(except controlled dangerous substances)] or device if, in his or her professional judgment, refusal would endanger the health or welfare of the patient, provided the following conditions are satisfied:

1. The pharmacist first ascertains to the best of his or her ability, by direct communication with the patient or caregiver, that such a medication or device was prescribed for that patient by order of a [licensed] practitioner[; and] . The pharmacist shall require the patient or caregiver to provide suitable identification. Such communication shall be documented in the patient profile record system maintained pursuant to N.J.A.C. 13:39-7.19 or in the pharmacy's other manual or electronic files; and

2. The pharmacist documents the [communication and requires the patient or caregiver to provide suitable identification and sign a statement attesting to the need before] dispensing of the emergency supply in the prescription record system .

(b) A pharmacist may dispense an emergency supply of a Schedule II controlled dangerous substance in the absence of a current, valid prescription upon receipt of oral authorization from a practitioner as provided under Federal law pursuant to 21 CFR 1306.11, consistent with the requirements of N.J.A.C. 8:65-7.8.

13:39-7.5 Approval of FDA necessary

(a) (No change.)

(b) The storage , labeling and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters the dispensing of such drugs shall not be construed to be a violation of (a) above. A pharmacy participating in experimental research shall comply with Federal Department of Health and Human Services regulations[,] set forth at 45 [C.F.R.] CFR Part 46, Protection of Human Subjects of Research[;] , incorporated by reference herein, as amended and supplemented and with the New Jersey Department of Health and Senior Services' Policy on the Protection of Human Research Subjects, incorporated by reference herein, as amended and supplemented, and which is available at http://www.state.nj.us/health/irb/policies.shtml.

13:39-7.6 Required records and documents

(a)-(d) (No change.)

(e) Notwithstanding the requirements of (d) above, a pharmacy shall maintain prescription records for controlled dangerous substances as required by Federal law consistent with the provisions of 21 CFR 1304.04.

13:39-7.7 Copies of prescriptions and/or patient profile

(a) A pharmacy shall immediately comply with the patient's request for copies of prescriptions and/or patient profile . Copies of prescriptions issued directly to the patient shall state in letters at least equal in size to those describing the medication dispensed, the underlined statement: "COPY--FOR INFORMATION ONLY."

(b) Presentation of a prescription marked "COPY--FOR INFORMATION ONLY" or a labeled prescription container [or a prescription marked "COPY--FOR INFORMATION ONLY"] shall be for information purposes only and shall have no legal status as a valid prescription order. The pharmacist in receipt of such copy or labeled prescription container shall contact the prescribing practitioner for a new prescription or the last dispensing pharmacy to transfer the prescription pursuant to N.J.A.C. 13:39-7.8.

13:39-7.8 Transfer of prescriptions between pharmacies

(a)-(c) (No change.)

(d) A prescription for a Schedule III, IV or V controlled substance may be transferred between pharmacies[, consistent with this section, one time only,] pursuant to N.J.A.C. 8:65-7.14(h) and 7.18(d). A prescription for a Schedule III, IV or V controlled substance that has been transferred shall not be transferred a second time. This prohibition shall not apply to the transfer of such prescriptions between pharmacies engaged in central prescription handling pursuant to N.J.A.C. 13:39-4.18(e) and to pharmacies that share a real-time, on-line database consistent with the requirements of 21 CFR 1306.25.

[(e) A prescription may be transferred electronically by pharmacists between pharmacies for the purpose of refill dispensing consistent with the requirements in N.J.A.C. 13:39-7.11.]

[(f)] (e) A prescription may be transferred [by telephone] between pharmacies for the purpose of refill dispensing by telephone, or by facsimile or electronic means as provided in N.J.A.C. 13:39-7.10 and 7.11, provided that:

1. The sending pharmacy invalidates the prescription on file as of the date the prescription is transferred and records on the back of the invalidated prescription order or in the electronic system the following:

i. (No change.)

ii. The name and address or store identifier of the pharmacy to which the prescription was transferred;

iii.-iv. (No change.)

2. The receiving pharmacy, upon receiving such prescription directly from another pharmacy, records the following:

i. The name[,] and address or store identifier and original prescription number of the pharmacy from which the prescription was transferred;

ii. (No change.)

iii. All information constituting a prescription order, as well as the following:

(1) (No change.)

[(2) Date of original dispensing;]

[(3)] (2) (No change in text.)

[(4) Complete refill record from original prescription;]

[(5)] (3) (No change in text.)

(4) Date the prescription was last filled; and

3. (No change.)

13:39-7.9 Filing and storage of controlled substance prescriptions

(a) (No change.)

(b) Prescriptions for all controlled substances listed in Schedules III, IV and V shall be maintained in a separate prescription file for such controlled substances only or in such form that they are readily retrievable from other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one-inch high and filed either in the prescription file for controlled substances listed in Schedule II or in the prescription file for non-controlled substances. If a pharmacy employs an electronic recordkeeping system for prescriptions [which] that permits identification by prescription number and retrieval of original documents by the [prescriber's] practitioner's name, patient's name, drug dispensed and date filled, then the requirement to mark the hard copy prescription with a red "C" shall be waived.

13:39-7.10 Prescriptions transmitted by facsimile

(a) (No change.)

(b) A pharmacist shall not fill a facsimile prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-[14] 40 , or the prescribing practitioner's authorized agent.

(c)-(f) (No change.)

(g) A pharmacist shall retain a printed copy of a facsimile prescription, or an electronic reproduction of the facsimile prescription that is readily retrievable and printable, for a minimum of five years [pursuant to N.J.S.A. 45:14-15]. The printed copy shall be of non-fading legibility.

(h)-(j) (No change.)

[page=149] (k) Nothing in this section shall be construed to preclude the facsimile transfer of information between pharmacies for purposes of transferring prescriptions pursuant to N.J.A.C. 13:39-7.8.

(l) A pharmacist shall not use a technological device in order to circumvent his or her responsibilities with regard to verifying the validity of prescriptions or in order to circumvent other standards of pharmacy practice.

13:39-7.11 Electronically transmitted prescriptions

(a) (No change.)

(b) A pharmacist shall not fill an electronic prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-[14] 40 , or the prescribing practitioner's authorized agent. If the electronic prescription is transmitted by the practitioner's authorized agent, the transmission shall include the full name and title of the agent.

(c)-(d) (No change.)

(e) An electronic prescription shall contain all information required to be included on a written prescription pursuant to New Jersey State Board of Medical Examiners rule N.J.A.C. 13:35-7.2(d), except that a handwritten original signature and an NJPB shall not be required for the prescription. Consistent with the requirements of N.J.A.C. 13:35-7.4A, the practitioner's electronic signature or other secure method of validation shall be provided with the electronic prescription unless the prescription is transmitted by the practitioner's authorized agent. If transmitted by an authorized agent, the full name and title of the agent shall be included on the transmission and the agent shall not sign the prescription.

(f) (No change.)

(g) A pharmacist shall retain a printed copy of an electronic prescription, or a record of an electronic prescription that is readily retrievable and printable, for a minimum of five years [pursuant to N.J.S.A. 45:14-15]. The printed copy shall be of non-fading legibility.

(h)-(l) (No change.)

(m) A pharmacist shall not use a technological device in order to circumvent his or her responsibilities with regard to verifying the validity of prescriptions or in order to circumvent other standards of pharmacy practice.

13:39-7.12 Labeling

(a) The dispensed container for any product shall bear a permanently affixed label with at least the following information:

1.-2. (No change.)

3. The brand name , or [generic name and if generic, the name of the manufacturer] if a generic, the brand name and the name of the generic in the following form, with the generic name and brand name inserted as appropriate: "--------- Generic for --------- ";

4.-8. (No change.)

9. The [prescriber] practitioner's name;

10.-12. (No change.)

(b)-(c) (No change.)

(d) When, in the judgment of the pharmacist, directions to the patient or cautionary messages are necessary, either for clarification or to ensure proper administration, storage or use of the medication, the pharmacist may add such directions or cautionary messages to those indicated by the [prescriber] practitioner on the original prescription.

13:39-7.13 Professional judgment in dispensing drugs

The pharmacist shall have the right to refuse to fill a prescription if, in his or her professional judgment, the prescription is outside the scope of practice of the [prescriber] practitioner ; or if the pharmacist has sufficient reason to question the validity of the prescription; or to protect the health and welfare of the patient.

13:39-7.16 Return of prescription medication

(a)-(b) (No change.)

(c) Prescription medication [which] that has been prepared for a patient, but which has not been dispensed to the patient, may be placed back in stock for reuse or resale provided that:

1.-3. (No change.)

4. In those circumstances in which prescription medications cannot be properly returned to the original manufacturers' stock containers, the medication shall be held in the pharmacy in the labeled container in which it has been repackaged . Prior to redispensing, such medications shall be placed in a new container with a new label or the original label shall be removed and the container shall be relabeled ;

5.-6. (No change.)

13:39-7.19 Patient profile record system

(a) A patient profile system must be maintained by all pharmacies for persons for whom prescriptions are dispensed. The Patient Profile Record System (PPRS) may be a manual or electronic system and shall be devised , so as to enable the immediate retrieval of information necessary to enable the dispensing pharmacist to identify previously dispensed medication and patient specific information at the time a prescription is presented for dispensing. One profile record may be maintained for members of a family living at the same address and possessing the same family name.

(b) The following information shall be recorded in the PPRS:

1.-5. (No change.)

6. The [prescriber's] practitioner's name;

7. The name, strength and quantity of the drug dispensed; [and]

8. Pharmacist's comments relevant to the patient's drug therapy[.] ; and

[(c)] 9. [The pharmacist shall attempt to ascertain and shall record any] Any allergies and idiosyncrasies of the patient and any medical conditions [which] that may relate to drug utilization, as communicated [to the pharmacist] by the patient or the patient's representative .

[1.] i. If there are no patient allergies, idiosyncrasies or medical conditions [which] that may relate to drug utilization, [the pharmacist shall so indicate on] such information shall be documented in the patient profile record system.

[(d)] (c) (No change in text.)

[(e) Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's profile record either in a manual or electronic data processing system before dispensing the medication, to determine the possibility of a potentially significant drug interaction, reaction or misutilization of the prescription. Upon determining a potentially significant drug interaction, reaction or misutilization, the pharmacist shall take the appropriate action to avoid or minimize the problem, which shall, if necessary, include consultation with the patient and/or the prescriber.

1. Except as set forth in (e)5 below, before dispensing a new prescription, the pharmacist shall make reasonable efforts to counsel the patient or caregiver. Counseling may, but need not, include the following:

i. The name and description of the medication;

ii. The dosage form, dosage, route of administration, and duration of drug therapy;

iii. Special directions and precautions for preparation, administration and use by the patient;

iv. Common adverse or severe side effects or interactions and contraindications that may be encountered, including their avoidance, and the action required if they occur;

v. Techniques for self-monitoring drug therapy;

vi. Proper storage;

vii. Prescription refill information; and

viii. Action to be taken in the event of a missed dose.

2. The offer to counsel may be made by ancillary personnel. However, counseling may be performed only by the pharmacist.

3. A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation. The absence of any record of a failure to accept the pharmacist's offer to counsel shall be presumed to signify that the offer was accepted and that the counseling was provided.

4. If the patient or caregiver is not physically present, the offer to counsel shall be made by telephone or in writing on a separate document accompanying the prescription. A written offer to counsel shall be in bold print, easily read, and shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population.

[page=150] 5. The requirements to counsel the patient or caregiver upon receipt of a new prescription, as set forth in (e)1 through 4 above, shall not apply to a pharmacist who dispenses any drug to an inpatient at a hospital or a long term care facility in which the resident is provided with 24 hour nursing care.

6. Upon receipt of a refill prescription, a pharmacist shall determine if a substantial time, as is appropriate for that drug in the reasonable and prudent pharmacist's professional judgment, has elapsed from the last filling. When necessary, the pharmacist shall consult with the and/or the patient to assure himself or herself that continued use is appropriate.

7. When patient profile records indicate sporadic, erratic or irrational use of medication by a patient, the pharmacist shall consult with the patient and/or the prescriber to determine if continued use is appropriate.]

[8.] (d) (No change in text.)

[9. All of the foregoing assumes the patient is willing and capable of participating in his or her own plan of care.]

[(f)] (e) A patient profile record shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years from the date of the last entry in the profile record. In using an electronic data processing system, the system shall have the capability of producing retrievable and readable documents of all original and refilled prescription data for a period of not less than five years, including the number of refills authorized by the [prescriber] practitioner . The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of [a] record information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

Recodify existing (g)-(i) as (f)-(h) (No change in text.)

[(j) Failure to comply with this section shall subject the pharmacist to disciplinary sanctions.]

13:39-7.20 Drug utilization review

(a) Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's profile record before dispensing the medication, to determine the possibility of a potentially significant drug interaction, reaction or misutilization of the prescription. Upon determining a potentially significant drug interaction, reaction or misutilization, the pharmacist shall take the appropriate action to avoid or minimize the problem, which shall, if necessary, include consultation with the patient and/or the practitioner.

(b) Upon receipt of a refill prescription, a pharmacist shall determine if a substantial time, as is appropriate for that drug in the pharmacist's professional judgment, has elapsed from the last filling. When necessary, the pharmacist shall consult with the practitioner and/or the patient to ensure that continued use of the medication is appropriate.

(c) When patient profile records indicate sporadic, erratic or irrational use of medication by a patient, the pharmacist shall consult with the patient and/or the practitioner to determine if continued use of the medication is appropriate.

13:39-7.21 Patient counseling

(a) Except as provided in (a)5 below, before dispensing a new medication, a pharmacist shall make reasonable efforts to counsel the patient or the patient's caregiver. Counseling may include the following:

1. The name and description of the medication;

2. The dosage form, dosage, route of administration, and duration of drug therapy;

3. Special directions and precautions for preparation, administration and use by the patient;

4. Common adverse or severe side effects or interactions and contraindications that may be encountered, including how to avoid such side effects, interactions and contraindications, and the action required if they occur;

5. Techniques for self-monitoring drug therapy;

6. Proper storage;

7. Prescription refill information; and

8. Action to be taken in the event of a missed dose.

(b) The offer to counsel may be made by pharmacy personnel. However, counseling shall be performed only by a pharmacist, or by a pharmacy intern or pharmacy extern under the immediate personal supervision of a pharmacist consistent with the requirements of N.J.A.C. 13:39-6.2(f)5.

(c) A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such counseling. The absence of any record of a failure to accept the pharmacist's offer to counsel shall be presumed to signify that the offer was accepted and that the counseling was provided.

(d) If the patient or caregiver is not physically present, the offer to counsel shall be made by telephone or in writing on a separate document accompanying the prescription. A written offer to counsel shall be in bold print, easily read, and shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population.

(e) The requirements of this section shall not apply to a pharmacist who dispenses any drug to an inpatient at a hospital or a long term care facility in which the resident is provided with 24-hour nursing care.

SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES

13:39-9.2 Definitions

The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

. . .

"Medication order" means a written request for medication originated by [an authorized prescriber] a practitioner and intended for patient use in the health care facility, and not for use of the institution's employees or their dependents or outpatients of the facility's clinics. A valid medication order contains the date ordered, the patient's name and location within the facility, the name, dose, route, and frequency of administration of the medication, and any additional instructions. Computer-generated medication orders within an institutional setting, utilizing the [prescriber's] practitioner's electronic signature or password will meet legal requirements for a [prescriber's] practitioner's original handwritten signature on medication orders. Computerized signatures or passwords will be accepted provided that the facility has adequate safeguards which assure the confidentiality of each electronic signature or password and which prohibit their improper or unauthorized use.

. . .

["Unit dose drug distribution system" means a system of dispensing drugs to be administered to patients of the facility whereby the medications are delivered daily (or more frequently) by the pharmacy to the patient care units in amounts equal to a 24-hour supply or less and are prepared, whenever possible, in single unit use packaging.]

"Unit [use] dose packaging" means a single unit use non-parenteral medication provided in [sealed] packaging which contains the following information for each unit in the package:

1.-3. (No change.)

[4. Use by date;]

4. The phrase "use by" followed by the product's use by date.

i. For purposes of this paragraph, "use by date" means the earlier of one year from the date of packaging or the expiration date on the manufacturer's container;

5.-6. (No change.)

13:39-9.5 Advisory committees

The [registered] pharmacist-in-charge, or designee, shall be an actively participating member on any committees of the facility that may be concerned with drugs and their utilization.

[page=151] 13:39-9.6 Pharmacy and Therapeutics Committee; applicability; polices and procedures

(a) (No change.)

(b) In all health care facilities providing pharmaceutical services to patients that are not required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of Health and Senior Services rules, the pharmacist-in-charge of the provider pharmacy, in cooperation with the health care facility, shall create policies and procedures as needed to provide pharmaceutical services to the health care facility. [The written] Copies of the policies and procedures shall be made available to the Board upon request .

13:39-9.7 (Reserved)

13:39-9.8 Control of health care pharmaceutical services; responsibilities of the [registered] pharmacist-in-charge of the provider pharmacy

(a) The pharmaceutical services of the health care facility shall be the responsibility of and under the control, supervision, and direction of the [registered] pharmacist-in-charge of the provider pharmacy.

(b) If a health care facility does not have an institutional pharmacy on its premises or chooses to utilize the services of a pharmacy outside the health care system, it may enter into an agreement with a retail pharmacy licensed by the Board. The [registered] pharmacist-in-charge of the retail pharmacy shall direct, control, supervise and be responsible for the pharmaceutical services provided to the facility.

(c) The [registered] pharmacist-in-charge of the provider pharmacy, with the cooperation of the Pharmacy and Therapeutics Committee, shall develop written policies and procedures as needed to provide pharmaceutical services to the facility. The written policies and procedures shall be available to the Board.

13:39-9.9 (Reserved)

13:39-9.10 Pharmaceuticals; drug supply; investigational drugs; controlled dangerous substances

(a) The pharmacist-in-charge shall be responsible for determining the specifications for drugs and pharmaceutical preparations used in the treatment of patients of the facility as to quality, quantity and source of supply. An authorized purchasing agent and/or materials manager and/or pharmacy buyer of the facility may perform the actual procurement. [In such a case, the] All purchase s shall be [supervised] reviewed by the pharmacist-in-charge or his or her designee, who shall be a pharmacist.

[(b) Drugs approved by the Pharmacy and Therapeutics Committee for use in the facility shall be of an amount sufficient to compound or dispense all medication orders and prescriptions which may reasonably be expected to be compounded or dispensed by the pharmacist.]

[(c)] (b) [The institutional pharmacy shall have an adequate inventory of drugs and biologicals to assure timely initiation of routine, and disaster drug therapy. Limited quantities of drugs shall be placed under controlled conditions in locations within the facility to assure immediate access by authorized licensed health care personnel for use in an emergency situation.] Written policies and procedures for the maintenance, content, control and accountability of drugs supplied and located throughout the facility shall be developed by the [registered] pharmacist-in-charge and approved by the Pharmacy and Therapeutics Committee.

[(d)] (c) Written policies and procedures for the control, use and accountability of Investigational New Drugs shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. The storage , labeling and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters, the dispensing of these drugs shall not be construed to be a violation of N.J.A.C. 13:39-7.5(a). A facility participating in experimental research involving residents [must be in compliance] shall comply with Federal Department of Health and Human Services regulations, set forth at 45 [C.F.R.] CFR Part 46, Protection of Human Subjects of Research, which is incorporated by reference herein, as amended and supplemented and with the New Jersey Department of Health and Senior Services' Policy on the Protection of Human Research Subjects, which is incorporated by reference herein, as amended and supplemented, and which is available at http://www.state.nj.us/health/irb/policies.shtml.

[(e) Investigational drugs shall be properly labeled and stored in the pharmacy until dispensed. Essential information on the investigational drug shall be maintained in the pharmacy. The investigational drug may be administered only after basic chemical, pharmaceutical and pharmacological information has been made available to all concerned and all the requirements of the Food and Drug Administration and the facility are satisfied.]

[(f)] (d) Written policies and procedures for the control, use and accountability of controlled dangerous substances shall be developed by the pharmacist-in-charge and the Pharmacy and Therapeutics Committee. Controlled dangerous substances shall be purchased, received, stored, dispensed, administered, recorded and controlled in accordance with State and Federal laws and regulations. [Written policies and procedures concerning control, use and accountability of controlled drugs shall be developed by the registered pharmacist-in-charge.]

13:39-9.11 Drug disbursement; written orders

(a) The pharmacist shall review the [prescriber's] practitioner's original order[,] or a [direct] copy [thereof, or a facsimile] of the original order generated by any media that facilitates the reproduction of the original order before any initial dose of medication is dispensed, except as provided for in N.J.A.C. 13:39-9.13.

(b)-(d) (No change.)

13:39-9.12 Drug disbursement; oral orders

(a) The provisions of this section shall be implemented in accordance with the [policy] policies and procedures of, and protocols of the Pharmacy and Therapeutics Committee.

(b) A pharmacist shall receive oral orders only from an authorized [prescriber] practitioner . Such orders shall be immediately recorded and signed by the person receiving the order on the medication order sheet or into the electronic data processing system.

(c) (No change.)

(d) Oral orders received consistent with the requirements of (b) and (c) above shall be countersigned by the [prescriber] practitioner .

(e) The pharmacist may release to the patient at discharge any remaining medication in a multiple dose container (for example, inhalers, multiple dose injectable medications , such as insulin, topical preparation, drops, ointments[,] and topical irrigation solutions), and a limited supply of other medications, provided that the pharmacist:

1. Labels the medications for out-patient use pursuant to labeling requirements set forth in [N.J.S.A. 45:14-24] N.J.A.C. 13:39-7.12 ;

2. Counsels the patient prior to discharge from the hospital or medical facility pursuant to N.J.A.C. 13:39-[7.19] 7.21 ; and

3. Ensures that discharge orders contain the attending physician's authorizations to [release] dispense the remaining doses of the prescription or the limited supply of other medications to the patient or guardian.

13:39-9.15 Drug labeling

Labeling of medications, other than intravenous solutions, shall be in conformance with written policies and procedures controlling the drug distribution system in use within the facility and in accord with current acceptable standards of pharmaceutical practice. Labeling of intravenous solutions shall be consistent with the labeling requirements set forth in N.J.A.C. 13:39-11.

13:39-9.16 Use of patient's own medication

(a) No drugs shall be administered to a patient except those provided through the pharmacy or as provided by written policies and procedures developed by the [registered] pharmacist-in-charge or, where applicable, the director of pharmaceutical services and approved by the Pharmacy and Therapeutics Committee.

(b) (No change.)

13:39-9.17 Drug-dispensing devices

(a) Where the use of a drug-dispensing device is approved as an integral part of the drug distribution system by the facility, the [registered] pharmacist-in-charge and the Pharmacy and Therapeutics Committee, the device may be used when the pharmacist is not on duty [page=152] (absent during either the day or night), provided that any absence of the pharmacist does not exceed 24 hours, or when the pharmacist is on duty, provided that proper review of the use of the drug-dispensing device can be ascertained. The supervision of any drug dispensing device so utilized shall be the responsibility of the [registered] pharmacist-in-charge servicing the health care facility. The drug-dispensing device data shall be checked for accuracy every 24 hours by a pharmacist and so documented.

(b) Packaging and labeling of medication for drug-dispensing devices, when done [in the facility] by the pharmacy , shall be performed under the immediate personal supervision of a pharmacist in the employ of or under contract to the facility.

(c)-(d) (No change.)

(e) Controlled substances and other medications to which, in the professional judgment of the [registered] pharmacist-in-charge, access should be limited, shall be secured within the drug dispensing device to limit access to single medications only and shall be checked and documented by the pharmacist or his or her designee who shall be a licensed health care professional, every 24 hours. Other than a pharmacist, only authorized registered nurses, licensed practical nurses, [physicians, authorized prescribers or designated] practitioners, pharmacy technicians, interns and externs shall have access to the medication in each drug-dispensing device. The activity regarding all medication, including the identity of the person accessing the medication, shall be recorded and available to the pharmacist.

(f) All medications withdrawn from a drug dispensing device require a medication order by an authorized [prescriber] practitioner . All such medication orders shall be checked by the pharmacist within 24 hours from the time of the original order and so noted on the pharmacy's patient medication profile.

(g) When there is no [licensed] pharmacy on the premises and when the drug-dispensing devices are an integral part of the approved drug distribution system of the facility, the devices shall be controlled by the [registered] pharmacist-in-charge who is responsible for the pharmaceutical services of the institution. Under these circumstances, the time between medication order checks shall not exceed 24 hours.

13:39-9.18 Disposal of unused medications

(a) Written policies and procedures governing unused medications shall be established and implemented by the [registered] pharmacist-in-charge and shall comply with the following requirements:

1.-4. (No change.)

13:39-9.19 Records and reports

(a) Records of the pharmaceutical services of the provider pharmacy for the facility shall be the responsibility of the [registered] pharmacist-in-charge. On or after April 5, 2011, a pharmacy shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) performing the component functions of prescription handling, as defined in N.J.A.C. 13:39-4.18, which are required to be performed by a pharmacist, pharmacy technician, intern or extern pursuant to the requirements of this chapter. All steps performed by a pharmacy technician, intern or extern shall be documented in the audit trail. All entries to the audit trail made by a pharmacy technician, intern or extern shall be reviewed and approved by the pharmacist. When more than one pharmacist is involved in the component functions of prescription handling, the unique and secure user identifier(s) of the pharmacist(s) responsible for the accuracy and appropriateness of each component function(s) shall be recorded in an audit trail. Audit trail documentation shall be generated at the time the component function(s) is performed. All audit trail and medication order information shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be maintained for a period of not less than five years. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

(b)-(e) (No change.)

(f) The [registered] pharmacist-in-charge shall be responsible for maintaining a system by which all reported adverse drug reactions are recorded and reviewed by the Pharmacy and Therapeutics Committee, where applicable, and are submitted to all appropriate State and local agencies consistent with State and local laws and regulations.

13:39-9.20 Drug information and education

(a) The [registered] pharmacist-in-charge shall be responsible for maintaining drug standards, references and sources of drug information current and adequate to meet the needs of the pharmacists, physicians, nurses, other health care personnel, and patients of the facility. Reference texts shall include, but not be limited to, those required by the Board under N.J.A.C. 13:39-5.8.

(b)-(c) (No change.)

13:39-9.21 After hours access to the institutional pharmacy

(a)-(c) (No change.)

(d) The [registered] pharmacist - in - charge shall obtain from the registered nurse on a suitable form a record of any drugs removed showing the following:

1.-6. (No change.)

(e) The [registered] pharmacist - in - charge shall obtain with the record in (d) above the container from which the required dose(s) was taken for drug administration purposes in order that it may be properly checked by a pharmacist.

(f) (No change.)

13:39-9.22 Pharmacy facilities; space

(a)-(b) (No change.)

[(c) The space provided for the institutional pharmacy shall be in accord with the size of the facility and the scope and complexity of the pharmaceutical services.]

13:39-9.23 Storage and security

(a) Provisions shall be made for adequate safe storage of drugs wherever they are stored in the health care facility.

1.-2. (No change.)

3. The [registered] pharmacist-in-charge or, where provided for in Department of Health and Senior Services rules, the director of pharmaceutical services shall be responsible for all the medications in the facility[, that is, the drugs in the pharmacy area, drugs in transit, and the drugs in the patient care areas].

4. (No change.)

(b) The pharmacist-in-charge or, where provided for in Department of Health and Senior Services rules, the director of pharmaceutical services shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least once every two months to check for expiration or use by dates, proper storage, misbranding, physical integrity, security and accountability of all drugs [dispensed for use]. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist[, except for hospitals, where they can also be prepared and signed] or by the pharmacy technician, intern or extern and co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns and externs are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the health care facility.

(c) Procedures shall be established to assure the immediate and efficient removal of all outdated and recalled drugs from patient care areas and from the active stock of the pharmacy. The [registered] pharmacist-in-charge shall develop written policies and procedures governing the removal from the facility of outdated or recalled drugs.

[page=153] 13:39-9.24 Equipment

Adequate equipment shall be provided for the compounding, packaging, labeling, refrigeration, sterilization, testing and safe distribution of drugs and other functions. [The equipment shall be sufficient to process drugs required by the facility.]

13:39-9.25 Institutional decentralized pharmacies

(a)-(e) (No change.)

(f) Institutional decentralized pharmacies shall comply with all requirements in this subchapter applicable to the pharmaceutical services provided by the decentralized pharmacy, as determined by the [registered] pharmacist-in-charge.

13:39-9.26 Valid medication orders; out-of-State medication orders

(a) Only medication orders issued by [an authorized prescriber] a practitioner licensed to write medication orders in the United States or any territory of the United States shall be considered valid medication orders and such medication orders shall be filled pursuant to New Jersey law.

(b) (No change.)

13:39-9.27 Prescriptions and medication orders transmitted by technological devices in an institution

(a) (No change.)

(b) A [registered] pharmacist filling prescriptions under an institutional permit for employees of the institution and their dependents and for eligible outpatients may accept for dispensing prescriptions for all substances [other than Schedule II controlled dangerous substances which have been transmitted by technological device, under the following conditions only:] consistent with the requirements of N.J.A.C. 13:39-7.10 and 7.11.

[1. Before releasing to other than an inpatient of a health care facility, as defined in N.J.A.C. 13:39-9.2, any prescription medication for a controlled dangerous substance listed in Schedules III, IV or V, the pharmacist shall obtain and file the original signed prescription.

2. The pharmacist shall, within 24 hours, reduce to hard copy, that is, record in his or her handwriting or enter into a computer, all prescriptions received by technological device other than prescriptions for Schedules III, IV and V controlled dangerous substances and shall place the copy in the permanent prescription file records.]

(c) A [registered] pharmacist who is authorized to fill inpatient medication orders, as defined in N.J.A.C. 13:39-9.2, in an institutional pharmacy may accept all inpatient medication orders, including orders for Schedule II substances, which have been transmitted by technological device. [Medication orders for narcotic Schedule II controlled substances written for long-term care facility residents or hospice patients or for direct administration to patients by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, which are transmitted by facsimile, shall serve as the original written medication orders, in accordance with the provisions of 21 C.F.R. 1306.11(d), (e), (f) and (g).]

(d)-(e) (No change.)

(f) No licensee or permit holder registered under N.J.S.A. 45:14-[1] 40 et seq. shall under any circumstances provide a technological device to, or accept a technological device from, any practitioner licensed to write prescriptions.

(g) (No change.)

SUBCHAPTER 10. AUTOMATED MEDICATION SYSTEMS

13:39-10.2 "Automated medication system" definition

As used in this subchapter, "automated medication system" means any process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing and distribution of medications, and which collects, controls and maintains all transaction information. "Automated medication system" does not mean an automatic counting device operated pursuant to N.J.A.C. 13:39-[5.11] 5.9 or a mechanical drug dispensing device operated pursuant to N.J.A.C. 13:39-9.17.

13:39-10.3 Authority to use automated medication system

(a) A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that:

1. The [registered] pharmacist - in - charge [or the registered pharmacist under contract with a healthcare facility responsible for the dispensing of medications, pursuant to N.J.S.A. 45:14-32, if an automated medication system is utilized at a location which does not have a pharmacy on-site, is] shall be responsible for the supervision of the operation of the system , or in the case of an automated medication system utilized at a location with no on-site pharmacy, the pharmacist-in-charge of the provider pharmacy shall be responsible for the supervision of the operation of the system ;

[2. The Board has conducted an inspection of the pharmacy, including an inspection of the automated medication system;]

2. The pharmacy has conducted a self-inspection of the automated medication system documented on a form provided by the Board and has submitted the self-inspection to the Board;

3. (No change.)

4. The pharmacy has made the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the self-inspection and/or of the system.

(b) The [registered] pharmacist-in-charge [or the registered pharmacist under contract with a healthcare facility responsible for the dispensing of medications] shall be responsible for the following:

1. (No change.)

2. Ensuring that medications in the automated medication system are inspected, at least [monthly] once every two months , for expiration or use by date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least [monthly] once every two months , for security and accountability;

3.-5. (No change.)

13:39-10.4 Written policies and procedures of operation

(a) When an automated medication system is used to fill prescriptions or medication orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall:

1.-2. (No change.)

3. Set forth methods that shall ensure retention of each amendment, addition, deletion or other change to the policies and procedures of operation for at least two years after the change is made. Each such change shall be signed or initialed by the [registered] pharmacist - in - charge and shall include the date on which the [registered] pharmacist - in - charge approved the change;

4. (No change.)

5. Set forth methods to identify the quality control measures in place to ensure the accuracy of the final dispensed product;

[5.] 6. (No change in text.)

[6.] 7. Set forth methods that shall ensure that access to the automated medication system for stocking and retrieval of medications is limited to licensed practitioners or qualified [support personnel acting] pharmacy technicians, interns and externs under the supervision of a [registered] pharmacist. An accountability record , which documents all transactions relative to stocking and removing medications from the automated medication system shall be maintained; and

[7.] 8. Identify the circumstances under which medications may be removed from the automated medication system by a licensed practitioner for distribution to a patient without prior order review by a [registered] pharmacist.

(b)-(c) (No change.)

13:39-10.5 Personnel training requirements

The [registered] pharmacist - in - charge shall be responsible for ensuring that, prior to performing any services in connection with an automated medication system, all [licensed practitioners] pharmacists and pharmacy technicians, interns and externs are trained in the pharmacy's standard operating procedures with regard to automated medication systems as set forth in the written policies and procedures of operation maintained pursuant to N.J.A.C. 13:39-10.4.

[page=154] SUBCHAPTER 12. NUCLEAR PHARMACIES

13:39-12.1 Definitions

The following words and terms when used in this subchapter shall have the following meanings, unless the context clearly indicates otherwise.

. . .

"Immediate personal supervision" means that the [registered] pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.

. . .

   
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