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NEW JERSEY REGISTER
VOLUME 41, ISSUE 15
ISSUE DATE: AUGUST 3, 2009
RULE ADOPTIONS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF PHARMACY
Adopted Amendments: N.J.A.C. 13:39-1.3, 2.1, 2.5, 3.3, 4.1, 4.5,
4.8, 5.3, 5.8, 5.12, 6.2, 6.4, 7.1 and 7.9
Adopted New Rules: N.J.A.C. 13:39-2.1, 2.5, 2.6, 2.7, 2A.1 and 2A.3
Adopted Recodifications and Amendments: N.J.A.C. 13:39-2.10 through
2.20 as 3.1 through 3.11 and 3.3 as 2A.2
Adopted Repeals: N.J.A.C. 13:39-2.2, 2.3, 2.4, 2.8, 2.9, 3.1, 3.2, 3.4,
3.5 and 8
Adopted Repeals and New Rules: N.J.A.C. 13:39-2.7 and 4.14
Fee Schedule; Requirements for Initial Licensure as a Pharmacist;
Licensure Examination Scores; Proof of Character; Criminal History
Background Check; Alleged Violations of Pharmacy Law; Internship and
Externship Practical Experience Requirements; Pharmacy Intern Registration
Requirements; Requirements for Reciprocal Licensure; Multistate Jurisprudence
Pharmacy Examination; Authorization to Practice; Display of License;
Replacement License; Change of Name; Change of Address of Record; Service
of Process; Verification of Licensure; Reproduction of License Prohibited;
Biennial License Renewal; Administrative Suspension; Reinstatement
from Administrative and Disciplinary License Suspensions; Inactive
Licensure; Steering Prohibited; Responsibilities of Pharmacists; New
Pharmacies; Pharmacy Departments; Eligibility and Application; Change
of Ownership; Asset Acquisition; Discontinued Pharmacies; Security
of Pharmacies and Pharmacy Departments; Pharmacy Signs; Minimum Equipment
and Facilities; Restriction on Storage of Prescription Legend Drugs
and Controlled Dangerous Substances; Registered Pharmacist-in-Charge;
Meal or Restroom Breaks; Valid Prescriptions; Out-of-State Prescriptions;
Filing and Storage of Controlled Substance Prescriptions
Proposed: January 20, 2009 at 41 N.J.R. 371(a).
Adopted: April 22, 2009 by the Board of Pharmacy, Edward G. McGinley,
R.Ph, President.
Filed: July 9, 2009 as R.2009 d.247, with technical changes not
requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).
Authority: N.J.S.A. 45:14-47 and 45:14-48.
Effective Date: August 3, 2009.
Expiration Date: December 10, 2009.
Federal Standards Statement
A Federal standards analysis is not required because the adopted amendments
and new rules are governed by N.J.S.A. 45:14-40 et seq., and are not
subject to any Federal requirements or standards. Although the rules
in N.J.A.C. 13:39 are not subject to any mandated Federal requirements
or standards, the Board has required licensees and permit holders, in
adopted new rule N.J.A.C. 13:39-4.14, to comply with the Federal requirements
set forth in 21 CFR 1301.74(c) when reporting a significant loss of prescription
legend drugs and devices and controlled substances.
Full text of the adoption follows (additions to proposal indicated
in boldface with asterisks *thus*; deletions from proposal indicated
in brackets with asterisks *[thus]*):
SUBCHAPTER 1. GENERAL PROVISIONS
13:39-1.3 Fee schedule
(a) The following fees shall be charged by the Board:
1. For pharmacists as follows:
i.-iii. (No change.)
iv. Application for reinstatement
(1) (No change.)
(2) Administrative suspension 225.00
[page=2971] v.-xiii. (No change.)
2.-4. (No change.)
5. For pharmacy interns as follows:
i. Application for registration 50.00
ii. Initial registration fee 70.00
iii. Registration renewal (One time only) 70.00
SUBCHAPTER 2. REQUIREMENTS FOR INITIAL LICENSURE
13:39-2.1 Requirements for initial licensure as a pharmacist
(a) An applicant for initial licensure as a pharmacist in New Jersey
shall satisfy the following requirements:
1. The applicant shall be at least 18 years of age and shall submit
a completed application for initial licensure, which shall include a
passport size photo of the applicant and the application fee set forth
in N.J.A.C. 13:39-1.3;
2. The applicant shall have graduated with either a degree of Bachelor
of Science in pharmacy with a minimum five-year course of study, or with
a Doctor of Pharmacy, from a school or college of pharmacy accredited
by the American Council of Pharmaceutical Education (ACPE) or deemed
ACPE-equivalent by ACPE;
i. The applicant shall submit an official transcript from the registrar
of the school or college of pharmacy substantiating that the applicant
has graduated;
ii. An applicant who has received a pharmacy degree from a school or
college of pharmacy located in a foreign country that has not been accredited
by ACPE or has not been deemed ACPE-equivalent by ACPE, shall satisfy
the requirements of (b) below;
3. The applicant shall have passed the North American Pharmacist Licensure
Examination (NAPLEX) and the Multistate Jurisprudence Pharmacy Examination
(MJPE), consistent with the requirements of N.J.A.C. 13:39-2.2. The applicant
shall take the NAPLEX and the MJPE only after providing the Board with
an official transcript and receiving authorization to test from the National
Association of Boards of Pharmacy (NABP). An applicant who has already
taken the NAPLEX and has had his or her scores transferred to New Jersey
within five years of having passed the examination consistent with N.J.A.C.
13:39-2.2, shall take the MJPE only after providing the Board with an
official transcript and receiving authorization to test from NABP allowing
the applicant to be admitted to the MJPE examination;
4. If the applicant is applying for initial licensure more than two
years following his or her graduation from pharmacy school, the applicant
shall complete *[1,420]* *1,440* hours of practical experience
in a Board-approved internship. The applicant shall register with the
Board as an intern and shall satisfy all internship requirements set
forth in N.J.A.C. 13:39-2.6 within the two*-*year period immediately
preceding the date of application; and
5. The applicant shall have satisfied the good moral character and
criminal history background check requirements set forth in N.J.A.C.
13:39-2.3 and 2.4.
(b) An applicant for initial licensure as a pharmacist in New Jersey
who has graduated from a school or college of pharmacy in a foreign country
that has not been accredited by ACPE or has not been deemed ACPE-equivalent
by ACPE, shall satisfy the following requirements:
1. The applicant shall be at least 18 years of age and shall submit
a completed application for initial licensure, which shall include a
passport size photo of the applicant and the application fee set forth
in N.J.A.C. 13:39-1.3;
2. The applicant shall have graduated with either a degree of Bachelor
of Science in pharmacy with a minimum five-year course of study or with
a Doctor of Pharmacy;
3. The applicant shall have a valid certification from the Foreign
Pharmacy Graduate Examination Committee (FPGEC) of NABP;
4. The applicant shall complete *[1,420]* *1,440* hours of practical
experience in a Board-approved internship. The applicant shall register
with the Board as an intern and shall satisfy all internship requirements
set forth in N.J.A.C. 13:39-2.6 within the two-year period immediately
preceding the date of application. The internship shall not commence
before the applicant has been certified by FPGEC;
5. The applicant shall have passed the NAPLEX and the MJPE, consistent
with the requirements of N.J.A.C. 13:39-2.2. The applicant shall take
the NAPLEX and the MJPE only after providing the Board with an official
transcript and receiving authorization to test from NABP. An applicant
who has already taken the NAPLEX and has had his or her scores transferred
to New Jersey within five years of having passed the examination consistent
with N.J.A.C. 13:39-2.2, shall take the MJPE only after providing the
Board with an official transcript and receiving authorization to test
from NABP allowing the applicant to be admitted to the MJPE examination.
An applicant shall not be eligible to take the referenced examination
until the completion of his or her internship; and
6. The applicant shall have satisfied the good moral character and
criminal history background check requirements set forth in N.J.A.C.
13:39-2.3 and 2.4.
13:39-2.2 Licensure examination scores
(a) An applicant for initial licensure shall attain a passing score
of not less than 75 on the North American Pharmacist Licensure Examination
(NAPLEX). If an applicant fails the NAPLEX, he or she shall be required
to repeat the examination.
(b) An applicant for initial licensure shall attain a passing score
of not less than 75 on the Multistate Jurisprudence Pharmacy Examination
(MJPE). If an applicant fails the MJPE, he or she shall be required to
repeat the examination.
(c) If an applicant fails either the NAPLEX or the MJPE three times,
the Board may direct the applicant to take remedial courses at an accredited
school or college of pharmacy prior to retaking the failed examination(s).
(d) NAPLEX and MJPE results shall be valid only for a period of five
years from the date that an applicant receives a passing score on the
respective examination.
13:39-2.3 Proof of character
(a) An applicant for initial licensure shall submit evidence of good
moral character, which shall be an ongoing requirement for licensure.
In determining whether the applicant shall be licensed in the State,
the Board shall consider evidence, which demonstrates that the applicant:
1.-2. (No change.)
3. Has not been convicted of violating any law relating to the practice
of pharmacy consistent with N.J.S.A. 45:1-21(f);
4. (No change.)
5. Has not had his or her license or, if a permit holder, his or her
permit, suspended or revoked as a result of any administrative or disciplinary
proceedings in this or any other jurisdiction which proved the applicant
to be in violation of any laws, rules or regulations pertaining to the
practice of pharmacy, and that the applicant is not currently under suspension
or revocation.
13:39-2.4 (No change in text.)
13:39-2.5 Refusal to license
The Board may refuse to issue a license to any applicant who has violated
any law related to the practice of pharmacy or for any of the reasons
set forth in N.J.S.A. 45:1-21 et seq.
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.
*"Extern preceptor" means an individual approved by an
American Council of Pharmaceutical Education (ACPE) approved school
or college of pharmacy, at which a pharmacy extern is enrolled, who
assumes the responsibility to supervise and provide instructional training
to a pharmacy extern.*
"Intern preceptor" means a pharmacist registered in this
State who assumes the responsibility to supervise and provide instructional
training to a pharmacy intern as set forth in (f) below.
*["Extern preceptor" means an individual approved by an American
Council of Pharmaceutical Education (ACPE) approved school or college
of pharmacy, at which a pharmacy extern is enrolled, who assumes the
responsibility to supervise and provide instructional training to a pharmacy
extern.]*
"Pharmacy extern" means any person who is in the fifth or
sixth college year, or the third or fourth professional year, at an ACPE-approved
school or college of pharmacy who is assigned to a pharmacy training
site for the purpose of acquiring practical experience under the supervision
of the school or college at which he or she is enrolled.
[page=2972]"Pharmacy intern" means a person who is employed
in an approved pharmacy training site for the purpose of acquiring practical
experience and who has first registered for such purposes with the Board
pursuant to N.J.S.A. 45:14-48b(2), and who has:
1. Graduated from an ACPE-approved school or college of pharmacy who
is making an application for initial licensure as a pharmacist more than
two years following the date of graduation;
2. Graduated from a school or college of pharmacy in a foreign country
that has not been accredited by ACPE or that has not been deemed ACPE-equivalent
by ACPE; or
3. Applied to the Board for reciprocal licensure and has not been engaged
in the practice of pharmacy for at least 1,500 hours within the two-year
period immediately preceding the date of application.
"Pharmacy internship or externship" means the program in
which practical experience is acquired by a pharmacy intern or extern.
"Pharmacy training site" means a site that is licensed by
the Board where drugs are dispensed or pharmaceutical care is provided
by a licensed pharmacist and that has a satisfactory record of observance
of Federal, State and municipal law and ordinances governing the activities
in which it is or has been engaged.
(b) The *[1,420]* *1,440* hours of practical experience required
for the successful completion of a pharmacy internship shall be obtained
consistent with the following:
1. The *[1,420]* *1,440* hours of practical experience shall
be completed in no less than 34 weeks and no more than 104 weeks, under
the supervision of an intern preceptor. Each week of practical experience
shall consist of no less than 15 hours and no more than 45 hours of actual
service per week;
2. The intern preceptor and the pharmacy intern shall keep accurate
records of the time spent by the pharmacy intern for credit toward the
requirements of (b)1 above. The Board shall provide appropriate forms
to be submitted to the Board for approval of internship experience; and
3. No credit shall be given for hours served as a pharmacy intern prior
to the applicant's registration with the Board and approval of the intern
preceptor by the Board.
(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 and employed 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. Has not been convicted of a crime or offense relating adversely
to the practice of pharmacy consistent with N.J.S.A. 45:1-21(f) or a
crime of moral turpitude and has not been the subject of disciplinary
action taken by a professional board resulting in the suspension, revocation
or surrender of a license or the placement of significant limitations
on such license.
(d) The Board shall approve an intern preceptor selected by each pharmacy
intern prior to the beginning of the internship. An intern preceptor
shall not supervise the training of more than one pharmacy intern at
a time.
(e) The intern preceptor in a pharmacy training site shall provide
the Board with a detailed written report outlining the progress, aptitude
and readiness to practice of any pharmacy intern under his or her supervision
at the conclusion of the internship.
(f) The intern preceptor shall be responsible for supervising the activities
of the pharmacy intern and providing the pharmacy intern with experience
and knowledge related to the preceptor's area of practice.
13:39-2.7 Pharmacy intern registration requirements
(a) No person shall be employed as a pharmacy intern until he or she
has been registered with the Board pursuant to this section and his or
her preceptor has been approved by the Board pursuant to N.J.A.C. 13:39-2.6(c).
(b) An applicant for registration as a pharmacy intern shall submit
a written application, on a form supplied by the Board, and shall submit:
1. His or her name, address and fingerprints for purposes of a criminal
history background check to be conducted by the State of New Jersey pursuant
to N.J.S.A. 45:1-28 et seq., (P.L. 2002, c. 104) to determine whether
criminal history record information exists that may disqualify the applicant
from being registered as a pharmacy intern by the Board;
2. A passport size photo of the applicant;
3. Evidence of good moral character, which shall be an ongoing requirement
for registration. In determining whether the applicant shall be registered,
the Board shall consider evidence, which demonstrates that the applicant:
i. Is not presently engaged in drug or alcohol use that is likely to
impair the ability to practice as a pharmacy intern with reasonable skill
and safety. For purposes of this section, the term "presently" means
at the time of application or any time within the previous 365 days;
ii. Has not been convicted of violating any law of this State or any
other state of the United States relating to controlled dangerous substances
or other habit-forming drugs;
iii. Has not been convicted of violating any law relating to the practice
of pharmacy consistent with N.J.S.A. 45:1-21(f) or a crime of moral turpitude;
and
iv. Has not had his or her authority to engage in the activity regulated
by the Board suspended or revoked as a result of any administrative or
disciplinary proceedings in this or any other jurisdiction that determined
the applicant to be in violation of any laws, rules or regulations pertaining
to the practice of pharmacy and that the applicant is not currently under
suspension or revocation; and
4. The application fee and registration fee set forth at N.J.A.C. 13:39-1.3.
(c) A person who has been educated in a foreign country in a college
or school of pharmacy that has not been approved by the American Council
of Pharmaceutical Education (ACPE) or that has not been deemed ACPE-equivalent
by ACPE, shall be certified by the Foreign Pharmacy Graduate Examination
Committee (FPGEC) of the National Association of Boards of Pharmacy prior
to applying to the Board for registration as a pharmacy intern.
(d) A pharmacy intern registration obtained pursuant to this section
shall be valid for a period of two years from the date of issuance. Upon
application to the Board, an intern registration may be renewed one time
only, on an individual basis, for reasons of military service, hardship,
illness or disability.
(e) A change in an intern preceptor shall require prior Board approval,
consistent with the requirements of N.J.A.C. 13:39-2.6(d). The new intern
preceptor shall be responsible for making application to the Board for
approval.
(f) The intern preceptor and the pharmacy intern shall notify the Board
in writing within 10 days of a change in the pharmacy training site and/or
the termination or resignation of the intern.
(g) In addition to the notification requirements of (f) above, a pharmacy
intern shall notify the Board in writing within 10 days of any change
in his or her name or address of record, as defined in N.J.A.C. 13:39-1.2.
SUBCHAPTER 2A. REQUIREMENTS FOR RECIPROCAL LICENSURE
13:39-2A.1 Requirements for reciprocal licensure
(a) Reciprocal licensure of out-of-State pharmacists shall be limited
to those pharmacists who have been duly licensed in mutually reciprocating
states and who satisfy the requirements of this section.
(b) A pharmacist currently licensed in a mutually reciprocating jurisdiction
shall satisfy the following requirements in order to obtain a license
by reciprocity in New Jersey:
1. The applicant shall be at least 18 years of age and shall submit
a completed application for reciprocity, including a passport size photo
of the applicant and the application fee set forth in N.J.A.C. 13:39-1.3.
The application shall substantiate that the applicant:
i. Has obtained his or her initial licensure by examination and that
the initial license is in good standing; and
ii. Has not had any other license granted to the applicant by any other
state suspended, revoked or otherwise restricted for any reason except
for the failure to renew, or for the failure to obtain the required continuing
education credits in any state where the applicant is currently licensed
but is not engaged in the practice of pharmacy;
[page=2973] 2. The applicant shall have graduated with either a degree
of Bachelor of Science in pharmacy with a minimum five-year course of
study, or a Doctor of Pharmacy degree, from a college or school of pharmacy
that has been accredited by the American Council of Pharmaceutical Education
(ACPE), or that has been deemed ACPE-equivalent by ACPE.
i. An applicant who has received a pharmacy degree from a school or
college of pharmacy located in a foreign country that has not been accredited
by ACPE or that has not been deemed ACPE-equivalent by ACPE, who wishes
to obtain a license by reciprocity in this State shall satisfy the requirement
of (c) below;
3. The applicant shall have engaged in the practice of pharmacy for
a period of at least 1,500 hours within the two-year period immediately
preceding the date of application; or shall have registered with the
Board as an intern and shall have satisfied all internship requirements
set forth in N.J.A.C. 13:39-2.6 within the two-year period immediately
preceding the date of application;
4. The applicant shall have passed the Multistate Jurisprudence Pharmacy
Examination (MJPE), consistent with N.J.A.C. 13:39-2A.5. The applicant
shall take the MJPE only after submitting all required documentation
to the Board and receiving authorization to test from the National Association
of Boards of Pharmacy (NABP); and
5. The applicant shall have satisfied the good moral character and
criminal history background check requirements set forth in N.J.A.C.
13:39-2A.2 and 2A.4.
(c) A pharmacist currently licensed in a mutually reciprocating jurisdiction
who received a pharmacy degree from a school or college of pharmacy located
in a foreign country that has not been accredited by ACPE or that has
not been deemed ACPE-equivalent by ACPE, who wishes to obtain a license
by reciprocity in this State shall satisfy the following requirements:
1. The applicant shall be at least 18 years of age and shall submit
a completed application for reciprocity, including a passport size photo
of the applicant and the application fee set forth in N.J.A.C. 13:39-1.3.
The application shall substantiate that the applicant:
i. Has obtained his or her initial licensure by examination and that
the initial license is in good standing; and
ii. Has not had any other license granted to the applicant by any other
state suspended, revoked or otherwise restricted for any reason except
for the failure to renew, or for the failure to obtain the required continuing
education credits in any state where the applicant is currently licensed
but is not engaged in the practice of pharmacy;
2. The applicant shall have a valid certification from the Foreign
Pharmacy Graduate Examination Committee (FPGEC) of NABP;
3. The applicant shall have graduated with either a degree of Bachelor
of Science in pharmacy with a minimum five-year course of study or a
Doctor of Pharmacy degree;
4. The applicant shall have engaged in the practice of pharmacy for
a period of at least 1,500 hours within the two-year period immediately
preceding the date of application.
i. An applicant who has engaged in the practice of pharmacy for less
than 1,500 hours, shall register with the Board as an intern and shall
satisfy all internship requirements set forth in N.J.A.C. 13:39-2.6 within
the two-year period immediately preceding the date of application;
5. The applicant shall have passed the Multistate Jurisprudence Pharmacy
Examination (MJPE), consistent with N.J.A.C. 13:39-2A.5. The applicant
shall take the MJPE only after submitting all required documentation
to the Board and receiving authorization to test from NABP; and
6. The applicant shall have satisfied the good moral character and
criminal history background check requirements set forth in N.J.A.C.
13:39-2A.2 and 2A.4.
(d) In addition to the requirements set forth in (a) and (b) above,
an applicant for licensure by reciprocity shall meet all licensure transfer
criteria utilized by NABP.
13:39-2A.2 Proof of character
(a) An applicant for licensure by reciprocity shall submit, as part
of his or her licensure application, evidence of good moral character,
which shall be an ongoing requirement for licensure. In determining whether
the applicant shall be licensed in the State, the Board shall consider
evidence, which demonstrates that the applicant:
1.-2. (No change.)
3. Has not been convicted of violating any law relating to the practice
of pharmacy consistent with N.J.S.A. 45:1-21(f);
4. (No change.)
5. Has not had his or her license suspended or revoked as a result
of any disciplinary proceedings in this or any other jurisdiction, which
proved the applicant to be in violation of any laws, rules or regulations
pertaining to the practice of pharmacy and that the applicant is not
currently under such suspension or revocation.
13:39-2A.3 Refusal to license
The Board may refuse to issue a license to any applicant for licensure
by reciprocity that has violated any law relating to the practice of
pharmacy or for any of the reasons set forth in N.J.S.A. 45:1-21 et seq.
Recodify existing N.J.A.C. 13:39-3.6 and 3.7 as 2A.4 and 2A.5 (No change
in text.)
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.
Recodify existing N.J.A.C. 13:39-2.11 through 2.14 as 3.2 through 3.5
(No change in text.)
13:39-3.6 Reproduction of license prohibited
The biennial license or wallet-sized license issued by the Board to
any pharmacist shall not be reprinted, photographed, photostated, duplicated
or reproduced by any other means either in whole or in part, except as
provided in N.J.A.C. 13:39-3.2.
13:39-3.7 (No change in text.)
13:39-3.8 Reinstatement from administrative and disciplinary license
suspensions
(a) A pharmacist who has had his or her license administratively suspended
pursuant to N.J.A.C. 13:39-3.7 may apply to the Board for reinstatement
within five years following the date of license expiration. A pharmacist
applying for reinstatement shall submit:
1.-5. (No change.)
(b)-(c) (No change.)
Recodify existing N.J.A.C. 13:39-2.18 and 2.19 as 3.9 and 3.10 (No
change in text.)
13:39-3.11 Responsibilities of pharmacists
(a) (No change.)
(b) Any pharmacist found to have violated the New Jersey Pharmacy Practice
Act, N.J.S.A. 45:14-40 et seq., or the rules in this chapter, shall be
subject to disciplinary action.
SUBCHAPTER 4. PHARMACY PERMIT REQUIREMENTS
13:39-4.1 New pharmacies; pharmacy departments; eligibility and application
(a) A permit application shall be submitted to the Board by every individual
or business entity desiring to operate a new pharmacy. Such application
shall be made on a form furnished by the Board. If the area for which
a pharmacy permit is sought is less than the total area of the premises,
the area subject to permit shall be known as the "pharmacy department."
(b) The permit application shall indicate the exact intended location
and plan or physical arrangement of the proposed pharmacy or pharmacy
department area, including any drive-thru area, and shall indicate any
[page=2974] area contiguous or adjacent to but not necessarily a part
of the proposed permitted area, and any area where drugs will be stored
and/or dispensed.
(c)-(f) (No change.)
(g) Before a permit may be issued to an applicant, the Board shall
inspect and approve the premises, fixtures and equipment of the new pharmacy
or pharmacy department to ensure compliance with this subchapter and
all relevant statutes, regulations and ordinances.
(h) (No change.)
13:39-4.5 Change of ownership; asset acquisition
(a) (No change.)
(b) Upon a change in ownership pursuant to (a) above, the new ownership
of such entity shall take custodial ownership of the previous five years
of prescription and profile records of the previous pharmacy and shall
ensure that the prescription and profile records are maintained pursuant
to N.J.A.C. 13:39-7.6 and 7.19 after the date of acquisition.
(c) Upon the sale, transfer or acquisition of the business assets of
a pharmacy, the person or entity acquiring such assets shall take custodial
ownership of the pharmacy's previous five years of prescription and profile
records and shall ensure that the prescription and profile records are
maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of
acquisition.
13:39-4.8 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) Within 30 days of closing a pharmacy pursuant to (a) above, the
permit holder or his or her representative shall remove all drug signs
from both the inside and outside of the discontinued pharmacy and shall
notify the Board in writing of the location of the previous five years
of prescription and patient profile records, consistent with the requirements
of N.J.A.C. 13:39-7.6 and 7.19. The permit holder or his or her representative
shall return the permit to the Board for cancellation within 30 days
of the closing. Prescription records and other information may be requested
by the Board as outlined in N.J.A.C. 13:39-7.6 and 7.19.
13:39-4.14 Security of pharmacies and pharmacy departments
(a) The registered pharmacist(s) on duty in all pharmacies, including
pharmacy departments, shall be responsible for:
1. Keeping the pharmacy or pharmacy department closed and the security
system turned on at all times when he or she is not present within the
permitted premises in the case of a pharmacy, or, in the case of a pharmacy
department, when he or she is not present within the department, except
as provided in N.J.A.C. 13:39-6.4;
i. In the case of a pharmacy or pharmacy department that has been issued
an institutional permit, pharmacy technicians may remain within the permitted
premises when the pharmacy or pharmacy department is closed and secured,
if the pharmacist determines, based on his or her professional judgment,
that the security of prescription legend drugs, devices and controlled
substances will be maintained in the pharmacist's absence;
2. Ensuring that the security of the prescription dispensing area and
its contents are maintained at all times, including the restriction of
persons unauthorized by the pharmacist on duty from being present in
the prescription dispensing area; and
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 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. The actual quantity of prescription legend drugs, devices or controlled
substances missing in relation to the type of business;
ii. The specific prescription legend drug, device or controlled substance
missing;
iii. Whether the loss of the prescription legend drug, device or controlled
substance can be associated with access to those drugs, devices or controlled
substances by specific individuals, or whether the loss can be attributed
to unique activities that may take place involving the drugs, devices
or controlled substances;
iv. A pattern of losses over a specific time period, whether the losses
appear to be random and the results of efforts taken to resolve the losses;
v. If known, whether the specific prescription legend drugs, devices
or controlled substances are likely candidates for theft or diversion;
and
vi. Local trends and other indicators of the theft or diversion potential
of the missing prescription legend drug, device or controlled substance.
(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 permit
of such report. The registered pharmacist-in-charge and the holder of
the pharmacy or pharmacy department permit shall ensure that:
i. A written report is filed with the Board upon discovery of the theft
or diversion or the significant loss of prescription legend drugs or
devices; and
ii. A written report is filed with the Federal Drug Enforcement Administration
upon discovery of the theft or diversion or any significant loss of controlled
substances, consistent with Federal requirements. A copy of such report
shall be filed with the Office of Drug Control, consistent with State
requirements and with the Board;
3. There is a secure area for receiving packages known to contain prescription
legend drugs and devices and controlled substances. No prescription drug
shall be accepted during the hours the pharmacy or pharmacy department
is closed unless adequate security for the storage of such shipments
has been provided; and
4. If a drop-off device is utilized for prescriptions, it is of a one-way,
irretrievable and secure design.
(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. The pharmacy department is constructed so as to enable the closing
off and securing of the department from the main store area. The department
shall be separated from the main store area by a secured barrier or partition
extending from the floor or fixed counter to the ceiling of either the
department or main store and attached thereto;
2. All medications requiring supervision of a pharmacist, including
dispensed medication, remain within the confines of the department when
the pharmacist is not in the pharmacy department;
3. The pharmacy department has a published telephone number different
from that of the establishment in which the department is [page=2975]
located. No extensions of this phone shall be located outside the department;
and
4. The telephone number of the registered pharmacist-in-charge is available
in the office of the manager of the establishment.
(d) The holder of a pharmacy or pharmacy department permit shall comply
with any law and/or ordinance of the municipality in which the pharmacy
or pharmacy department is located requiring the placement of a security
key box on the exterior of the pharmacy or the premises in which the
pharmacy department is located for purposes of permitting emergency access
to the premises.
SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS
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.
13:39-5.8 Minimum equipment and facilities
(a) The following minimum equipment and facilities shall be required
to be in every prescription area, and this equipment shall be stored
so as to be readily accessible and shall be kept in a clean condition:
1.-3. (No change.)
4. Storage place of substantial construction, which is capable of being
securely locked when the pharmacist is not present in the prescription
dispensing area, for Schedule II controlled substances, if not dispersed;
5.-18 (No change.)
13:39-5.12 Restriction on storage of prescription legend drugs and
controlled dangerous substances
(a) Prescription legend drugs, devices and controlled dangerous substances
shall not be stored in the pharmacy or pharmacy department in such a
manner as to be accessible to the public.
(b) Prescription legend drugs, devices and controlled dangerous substances
shall only be stored in areas of the premises that are part of the permitted
pharmacy or pharmacy department.
13:39-6.2 Registered pharmacist-in-charge
(a)-(e) (No change.)
(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.-3. (No change.)
4. Security of the prescription area and its contents are maintained
at all times consistent with the requirements set forth in N.J.A.C. 13:39-4.14;
5.-9. (No change.)
13:39-6.4 Meal or restroom breaks
(a) A sole pharmacist on duty may take restroom breaks and 30-minute
meal breaks while working in a pharmacy consistent with the following
requirements:
1. (No change.)
2. The pharmacy shall remain open during the restroom or meal breaks,
provided a pharmacy employee remains present in the pharmacy, for patient
related services, which include, but are not limited to, the following:
i.-ii. (No change.)
3. A sign shall be posted in the prescription dispensing area stating "Pharmacist
on break, but available for emergencies and counseling."
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 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 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 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.)
13:39-7.9 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 permits identification by prescription number and retrieval of
original documents by the prescriber'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.
SUBCHAPTER 8. (RESERVED)
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