N.M. Admin. Code § 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
identifes 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 identifed patient, the statement "office use only";
(x) a list of the active and inactive
ingredients, identifed 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
identifed 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, identifed 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 identifed,
directly or as part of a category of drugs, on a list published by the FDA that
present demonstrable diffculties 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 benefts to patients;
or
(2) that is compounded in
accordance with all applicable conditions identifed on the drug list as
conditions that are necessary to prevent the drug or category of drugs from
presenting demonstrable diffculties.
L.
DISPENSING, COMPOUNDING, AND SALE OF
DRUGS; LIMITATIONS. A resident pharmacy shall limit the interstate
dispensing of compounded sterile human drug preparation to fve 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.
Notes
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