TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 37 MINIMUM STANDARDS FOR OUTSOURCING FACILITIES
16.19.37.1 ISSUING AGENCY: Regulation and
Licensing Department - Board of Pharmacy.
[16.19.37.1 NMAC - N, 12-13-15]
16.19.37.2 SCOPE:
All outsourcing facilities, resident and nonresident, and
all persons or entities that own or operate, or are employed by, an outsourcing
facility for the purpose of providing pharmaceutical products or services.
[16.19.37.2 NMAC - N, 12-13-15]
16.19.37.3 STATUTORY AUTHORITY: Section 61-11-6 A(6)
NMSA 1978 authorizes the board of pharmacy to provide for the licensing of drug
manufacturers and for the inspection of their facilities and activities; and to
enforce the provisions of all state laws pertaining to the practice of pharmacy
and the manufacture,
production,
sale or distribution of drugs, cosmetics or poisons, including the New Mexico
Drug, Device and Cosmetic Act, Chapter 26, Article I NMSA 1978. Pursuant to Section 26-1-18 of the Drug,
Device and Cosmetic Act, the board is authorized to promulgate regulations for
the efficient enforcement of the act.
[16.19.37.3 NMAC - N, 12-13-15]
16.19.37.4 DURATION: Permanent.
[16.19.37.4 NMAC - N, 12-13-15]
16.19.37.5 EFFECTIVE DATE: December 13, 2015,
unless another date is cited at the end of a section.
[16.19.37.5 NMAC - N, 12-13-15]
16.19.37.6 OBJECTIVE: The objective of 16.19.37 NMAC is to
establish standards for the safe and competent manufacture and distribution of
drugs by outsourcing facilities.
[16.19.37.6 NMAC - N, 12-13-15]
16.19.37.7 DEFINITIONS:
A. “Administer”
means the direct application of a drug to the body of a patient or research
subject by injection, inhalation, ingestion or any other means as a result of
an order of a licensed practitioner.
B. “Board”
means the New Mexico board of pharmacy.
C. “CFR”
means code of federal regulations.
D. “Compounding”
means;
(1) manufacturing
by an outsourcing facility in accordance with the conditions and requirements
of Section 503B of the Federal Food, Drug, and Cosmetic Act; and
(2) manufacturing
by a dual purpose facility in accordance with the conditions and requirements of
Section 503A, and 503B as applicable, of the Federal Food, Drug, and Cosmetic
Act; and
(3) the
combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise
altering of a drug or bulk drug substance to create a drug; by an outsourcing
facility or dual purpose facility.
E. “Dispense” means the evaluation and
implementation of a prescription, including the preparation and delivery of a
drug or device to a patient or patient's agent in a suitable container
appropriately labeled for subsequent administration to or use by a patient.
F. “Distribute” means the delivery of a
drug or device other than by administering or dispensing.
G. “Dual purpose
facility” an outsourcing facility licensed in the state of New Mexico that
is also licensed in the state of New Mexico as a pharmacy or non-resident
pharmacy.
H. “Manufacture”
means the steps in the preparation, propagation, processing or compounding of a
drug - the making by chemical, physical, biological or other procedures of any
articles which meet the definition of drugs and includes manipulation, sampling
or control procedures resulting in the finished dosage form. Manufacture includes all the steps performed
on the product itself, which do not affect intrinsically the safety, purity or
potency of the product.
I. “Nonresident outsourcing facility”
means any outsourcing facility located outside New Mexico, that ships, mails or
delivers, in any manner, prescription drugs into New Mexico.
J. “Outsourcing
facility” means a facility that is currently registered with the Food and Drug
Administration (FDA) as an outsourcing facility under Section 503B of the Federal
Food, Drug, and Cosmetic Act,
and that meets the requirements of that agency to engage in the compounding and
distribution of sterile drugs.
K. “Pharmacist in charge” means a
pharmacist who accepts responsibility for the operation of a dual purpose
facility or outsourcing facility in conformance with all laws and rules
pertinent to the facility operational standards, the practice of pharmacy, and
the distribution or dispensing of drugs and who is personally in full and
actual charge of the facility and its personnel.
L. “REMS” means a FDA
approved risk evaluation and mitigation strategy.
M. “Resident state” means the state in
which the nonresident outsourcing facility is physically located in.
N. “The finished dosage form” of a
prescription drug is defined as that form of the drug which is or is intended
to be dispensed or administered to the patient and requires no further
manufacturing or processing other than packaging and labeling.
[16.19.37.7 NMAC - N, 12-13-15]
16.19.37.8 LICENSURE
OR REGISTRATION:
A. Any outsourcing facility that is engaged
in the compounding of sterile drugs in this state shall be registered as an
outsourcing facility under the Federal Food, Drug, and Cosmetic Act and be
licensed as an outsourcing facility in this state.
B. Any nonresident
outsourcing facility, that distributes or causes to be distributed, compounded
sterile drugs into New Mexico shall be registered as an outsourcing facility
under the Federal Food, Drug, and Cosmetic Act and be licensed as a nonresident
outsourcing facility.
C. No outsourcing facility shall ship,
mail or deliver controlled substances in or into this state unless registered
by the Drug Enforcement Administration (DEA) and the board for controlled
substances.
D. Applications for a nonresident outsourcing facility under
this section shall be made on a form furnished by the board. The board may require such information as it
deems is reasonably necessary to carry out the purposes of this section.
E. The board shall
not issue an initial or renewed license for an outsourcing facility unless the
facility furnishes the board with a report, issued by the appropriate
regulatory agency of the resident state, or entity approved by the appropriate
regulatory agency of the resident state, or by the FDA, of an inspection that
has occurred within the 12 months immediately preceding receipt of the license
application by the board (with no intervening change in outsourcing facility
ownership). The board may deny licensure
unless the applicant submits documentation satisfactory to the board that any
deficiencies noted in an inspection report have been corrected.
F. No license shall
be issued or renewed for an outsourcing facility unless the applicant supplies
the board with proof of such registration by the FDA.
G. No license shall
be issued or renewed for a non-resident outsourcing facility that is required
to be licensed or registered by the state in which it is physically located
unless the applicant supplies the board with proof of such licensure or
registration. The board may establish,
by rule, standards for the licensure of an outsourcing facility that is not
required to be licensed or registered by the state in which it is physically
located.
H. The license fee shall be as specified in 16.19.12 NMAC, and
shall be renewed biennially before the last day of December each year.
I. The board may deny, revoke or suspend an outsourcing
facility’s registration for any violation of the state drug laws.
[16.19.37.8 NMAC - N, 12-13-15]
16.19.37.9 OPERATIONAL
STANDARDS: The
following minimum standards shall apply to all outsourcing facilities and dual
purpose facilities for which licenses have been issued by the board:
A. All drugs and chemicals used in the manufacturing process
or held for sale shall conform to the Drug, Device and Cosmetic Act and shall
be stored, preserved and disposed of as prescribed by laws regulating the labeling
and manufacture of drugs. When
necessary, and/or according to label requirements, all drugs and chemicals
which require refrigeration shall be stored and preserved under proper
temperature.
B. Facilities must comply with applicable FDA
current good manufacturing practice requirements as set forth in title 21, CFR,
Subsection 211.1 to 211.208 inclusive (or successor regulations). The definitions and interpretations contained
in Section 201 of the Federal Food and Drug Act shall be applicable.
C. Facilities must
be in compliance with applicable DEA regulations.
D. Facilities must comply with applicable United States
Pharmacopeia requirements.
[16.19.37.9 NMAC - N, 12-13-15]
16.19.37.10 MINIMUM REQUIREMENTS:
A. PHARMACIST IN CHARGE.
(1) Any drugs
compounded in an outsourcing facility or dual purpose facility licensed pursuant
to this rule shall be compounded by or under the direct supervision of a
licensed pharmacist and in accordance with all applicable federal and state
laws.
(2) Any drugs
repackaged in an outsourcing facility licensed pursuant to this rule shall be
repackaged by or under the direct supervision of a licensed pharmacist and in
accordance with all applicable federal and state laws.
(3) The pharmacist
in charge shall be responsible for the maintenance and implementation of
appropriate policies and procedures.
(4) The pharmacist
in charge shall be responsible for ensuring proper training and competence of
personnel for all duties assigned to or undertaken by personnel.
(5) The pharmacist
in charge shall be responsible for ensuring personnel are properly licensed or
registered with the board.
(6) The pharmacist
in charge shall be responsible for compliance with all federal regulations
applicable to outsourcing facilities, and all regulations administered by the board.
B. DUAL PURPOSE FACILITY.
(1) No outsourcing
facility may dispense any drug to any person pursuant to a prescription unless
it is also licensed as a pharmacy (or nonresident pharmacy) in this state and
meets all other applicable requirements of federal and state law.
(2) Required records
of the outsourcing facility shall be maintained separate from required records
of the pharmacy.
C. RESTRICTIONS.
(1) Any drugs
compounded in an outsourcing facility licensed pursuant to this rule shall be
compounded in accordance with all applicable federal and state laws.
(2) Any drugs
repackaged in an outsourcing facility licensed pursuant to this rule shall be
repackaged in accordance with all applicable federal and state laws.
(3) Each repackaged
drug product is also accompanied by a copy of the prescribing information that
accompanied the original drug product that was repackaged.
(4) The drug product
is included on a report submitted to FDA each June and December identifying the
drug products made by the outsourcing facility during the previous six month
period, and providing the active ingredient(s); source of the active
ingredient(s); national drug code (NDC) number of the source ingredient(s), if
available; strength of the active ingredient(s) per unit; the dosage form and route
of administration; the package description; the number of individual units
produced; and the NDC number of the final product, if assigned.
D. LABELING OF DRUGS COMPOUNDED OR REPACKAGED BY AN
OUTSOURCING FACILITY.
(1) The label of any drug compounded by an outsourcing facility shall include,
but not be limited to the following:
(a) a statement that
the drug is a compounded drug or a reasonable comparable alternative statement
that prominently identifies the drug as a compounded drug;
(b) the name,
address, and phone number of the applicable outsourcing facility; and
(c) with respect to
the drug:
(i) the lot or batch
number;
(ii) the established
name of the drug;
(iii) the dosage form
and strength;
(iv) the statement of
quantity or volume, as appropriate;
(v) the date that
the drug was compounded;
(vi) the expiration
date;
(vii) storage and
handling instructions;
(viii) the NDC number,
if available;
(ix) the statement
that the drug is not for resale, and if the drug product is distributed by an
outsourcing facility other than pursuant to a prescription for an individual
identified patient, the statement “office
use only”;
(x) a list of the
active and inactive ingredients, identified by established name, and the
quantity or proportion of each ingredient.
(2) The label on the
immediate container (primary packaging, e.g., the syringe) of the repackaged product
includes the following:
(a) the statement “this
drug product was repackaged by (name of outsourcing facility)”;
(b) the address and
phone number of the outsourcing facility that repackaged the drug product;
(c) the established
name of the original, approved drug product that was repackage;
(d) the lot or batch
number of the repackaged drug product;
(e) the dosage form
and strength of the repackaged drug product;
(f) a statement of
either the quantity or volume of the repackaged drug product, whichever is
appropriate;
(g) the date the
drug product was repackaged;
(h) the beyond use
date of the repackaged drug product;
(i) storage and
handling instructions for the repackaged drug product;
(j) the NDC number
of the repackaged drug product, if
available;
(k) the statement “not
for resale,” and, if the drug product is distributed by an outsourcing facility
other than pursuant to a prescription for an individual identified patient, the
statement “office use only”;
(l) when included on
the label of the FDA approved drug product from which the drug product is being
repackaged, a list of the active and inactive ingredients, unless such
information is included on the label for the container from which the
individual units are removed, as described below:
(i) the label on the
container from which the individual units are removed for administration
(secondary packaging, e.g., the bag, box, or other package in which the
repackaged products are distributed) includes;
(ii) the active and
inactive ingredients, if the immediate drug product label is too small to
include this information;
(iii) the directions
for use, including, as appropriate, dosage and administration, and the
following information to facilitate adverse event reporting: www.fda.gov/medwatch
and 1-800-FDA-1088.
E. CONTAINER. The container from which the individual
units of the drug are removed for dispensing or for administration (such as a
plastic bag containing individual product syringes) shall include:
(1) a list of active
and inactive ingredients, identified by established name, and the quantity or
proportion of each ingredient; and
(2) any other
information required by regulations promulgated by the commissioner to
facilitate adverse event reporting in accordance with the requirements
established in Section 310.305 of title 21 of the Code of Federal Regulations (CFR).
F. BULK DRUGS. A drug may only be compounded in an
outsourcing facility that does not compound using bulk drug substances as
defined in Section 207.3(a)(4) of title 21 of the CFR or any successor regulation
unless:
(1) the bulk drug
substance appears on a list established by the FDA identifying bulk drug
substances for which there is a clinical need;
(2) the drug is
compounded from a bulk drug substance that appears on the federal drug shortage
list in effect at the time of compounding, distributing, and dispensing;
(3) if an applicable
monograph exists under the USP-NF, or another compendium or pharmacopeia
recognized by the FDA and the bulk drug substances each comply with the
monograph; and
(4) the bulk drug
substances are each manufactured by an establishment that is registered with
the federal government.
G. INGREDIENTS. When an outsourcing facility uses
ingredients, other than bulk drug substances, such ingredients must comply with
the standards of the applicable USP-NF monograph, if such monograph exists, or
of another compendium or pharmacopeia recognized by the FDA for purposes of
this subdivision, if any.
H. UNSAFE OR INEFFECTIVE DRUGS. No outsourcing facility may
compound or repackage a drug that appears on a list published by the FDA that
has been withdrawn or removed from the market because such drugs or components
of such drugs have been found to be unsafe or not effective.
I. PROHIBITION ON WHOLESALING. No compounded or repackaged drug will be sold
or transferred by any entity other than the outsourcing facility that
compounded or repackaged such drug. This
does not prohibit the administration of a drug in a health care setting or
dispensing a drug pursuant to a properly executed prescription.
J. PROHIBITION AGAINST COPYING AN APPROVED DRUG. No
outsourcing facility may compound a drug that is essentially a copy of one or
more approved drugs.
K. PROHIBITION AGAINST COMPOUNDING DRUGS PRESENTING
DEMONSTRABLE DIFFICULTIES. No outsourcing facility may compound a
drug:
(1) that is
identified, directly or as part of a category of drugs, on a list published by
the FDA that present demonstrable difficulties for compounding that are
reasonably likely to lead to an adverse effect on the safety or effectiveness
of the drug or category of drugs, taking into account the risks and benefits to
patients; or
(2) that is
compounded in accordance with all applicable conditions identified on the drug
list as conditions that are necessary to prevent the drug or category of drugs
from presenting demonstrable difficulties.
L. DISPENSING, COMPOUNDING, AND SALE OF DRUGS; LIMITATIONS. A
resident pharmacy shall limit the interstate dispensing of compounded sterile
human drug preparation to five percent of the total prescriptions dispensed by
that pharmacy, unless registered with the FDA and the board as an outsourcing
facility. This requirement will be
effective at the time it becomes enforced by the FDA in states that have not
entered into a memorandum of understanding with the FDA.
M. ADVERSE EVENT REPORTS.
(1) Outsourcing
facilities shall submit a copy of all adverse event reports submitted to the
FDA in accordance with the content and format requirements established in
section 310.305 of title 21 of the CFR, or any successor regulation, to the
executive director of the board. Upon
request, follow up reports required by the FDA shall be submitted to the
executive director of the board.
(2) Outsourcing
facilities shall develop and implement written processes for the surveillance,
receipt, evaluation, and reporting of adverse events for the drug products it
compounds or repackages as described in 310.305(a) and 211.198 of title 21 of
the CFR.
N. DRUG THAT IS THE SUBJECT OF A REMS. If the outsourcing facility compounds from a
drug that is the subject of a REMS approved with elements to assure safe use,
or from a bulk drug substance that is a component of such drug, the outsourcing
facility must demonstrate to FDA before beginning to compound that it will use
controls comparable to the controls applicable under the REMS.
O. DRUG RECORDS.
(1) Outsourcing
facilities shall establish and maintain inventories and records of all
transactions regarding the receipt and distribution or other disposition of
compounded sterile drugs. These records
shall include the following information:
(a) the identity and
quantity of the drugs received and distributed or disposed of;
(b) the dates of
receipt and distribution or other disposition of the drugs;
(c) the name,
location and license number of the business, health care practitioner or other
entity appropriately licensed to possess, dispense, distribute, administer or
destroy prescription drugs.
(2) There shall be a
mechanism for tracking and retrieving products that have
been recalled.
(3) Resident
outsourcing facilities shall maintain compounded sterile preparation batch
records in accordance with Subsection B of 16.19.36.15 NMAC.
(4) A
record of drugs repackaged must be kept, and include the following: the name
and strength of the drug, lot number, name of manufacturer or distributor,
beyond use date, date of repackaging, total number of dosage units repackaged,
quantity or volume per repackaged container, number of dosage units wasted,
initials of repackager and of pharmacist performing final check.
(5) All drugs
repackaged by a pharmacist intern or pharmacy technician must undergo a final
check by the pharmacist.
(6) Every registrant
under the Controlled Substances Act, manufacturing, distributing or dispensing
a controlled substance shall maintain, on a current basis, a complete and
accurate record of each substance manufactured, received, sold or delivered by
him in accordance with regulations of the board.
(7) Records shall be
kept by all persons licensed pursuant to the Pharmacy Act of all dangerous
drugs, their receipt, withdrawal from stock and use or other disposal. The records shall be open to inspection by
the board or its agents, and the licensee shall be responsible for the
maintenance of the records in proper form.
(8) Records required
by board-administered law or regulation shall be available for inspection and
photocopying by the board’s state drug inspectors for three years.
P. SUCCESSOR REGULATIONS OR FEDERAL FOOD, DRUG AND COSMETIC
ACT SECTIONS. 16.19.37 NMAC shall apply
to any successor or re-designated CFR, or Federal Food, Drug, and Cosmetic Act
section referenced in this part.
[16.19.37.10
NMAC - N, 12-13-15]
HISTORY
OF 16.19.37 NMAC: [RESERVED]