New Mexico Register / Volume XXIV, Number 11 / June 14, 2013
This is an
amendment to 16.19.30 NMAC, Section 9, effective 06-29-13.
16.19.30.9 OPERATIONAL STANDARDS:
A. General
requirements.
(1) Non-sterile drug products may be compounded
in licensed pharmacies as a result of a practitioner’s prescription order based
on the practitioner-patient-pharmacist relationship in the course of
professional practice.
(2) Preparing limited quantities of
prescription drug orders in anticipation based upon a history of receiving
valid prescriptions issued within an established
practitioner-patient-pharmacist relationship in the course of professional
practice.
(a) The beyond-use date should be based on the
criteria outlined in USP Chapter <795>.
(b) Any product compounded in anticipation of
future prescription drug or medication orders shall be labeled. Each label shall contain:
(i) name and strength
of the compounded medication or list of the active ingredient and strengths;
(ii) facility’s
lot number;
(iii) beyond-use date;
(iv) quantity
or amount in the container.
(3) Commercially available product may be
compounded for dispensing to individual patients provided the following
conditions are met:
(a) the commercial
product is not reasonably available from normal distribution channels in a
timely manner to meet patient’s needs; and
(b) the prescribing
practitioner has requested that the drug be compounded; or
(c) if the compounded product is changed to
produce for that patient a significant difference, as authorized by the
prescriber, between the compounded drug and the comparable commercially
available drug product, or if use of the compounded product is in the best
interest of the patient; “significant difference” would include the removal of
a dye for medical reason such as an allergic reaction; when a compounded
product is to be dispensed in place of a commercially available product, the
prescriber and patient shall be informed that the product will be compounded.
[(4) Compounding for a prescriber’s office use.
(a) Pharmacies may prepare compounding drug
products for a duly authorized prescriber’s office use.
(b) An order by the duly authorized
prescriber, indicating the formula and quantity ordered will be filed in the
pharmacy.
(c) The product is to be administered in the
office.
(d) A record of the compounded drug product
may be kept as a prescription record in the pharmacy computer or by hard-copy
record.
(e) A label may be generated and a number
assigned by the pharmacy computer for the compounded drug product.]
[(5)] (4) Compounding veterinarian products.
(a) Prescriptions for animals may be
compounded based on an order or prescription from a duly authorized
veterinarian.
(b) These prescriptions are to be handled and
filled the same as the human prescriptions.
[(6)] (5) Compounding pharmacies/pharmacists may
advertise and promote the fact that they provide non-sterile prescription
compounding services which may include specific drug products and classes of
drugs.
B. Environment.
(1) Pharmacies regularly engaging in
compounding shall have a designated and adequate area for the safe and orderly
compounding of drug products including the placement of equipment and
materials. Pharmacies involved in
occasional compounding shall prepare an area prior to each compounding
activity, which is adequate for safe and orderly compounding.
(2) Only personnel authorized by the
responsible pharmacist shall be in the immediate vicinity of a drug compounding
operation.
(3) A sink with hot and cold running water,
exclusive of rest room facilities, shall be accessible to the compounding areas
and be maintained in a sanitary condition.
(4) When drug products that require special precautions
to prevent contamination, such as penicillin, are involved in a compounding
operation, appropriate measures, including dedication of equipment for such
operations or the meticulous cleaning of contaminated equipment prior to its’
use for the preparation of other drug products, must be used in order to
prevent cross-contamination.
C. Equipment and supplies.
The pharmacy shall:
(1) have a class A
prescription balance, or analytical balance and weights when necessary which
shall be properly maintained and subject to inspection by the New Mexico board
of pharmacy and;
(2) have equipment
and utensils necessary for the proper compounding of prescription or medication
drug orders; such equipment and utensils used in the compounding process shall
be:
(a) of appropriate
design and capacity, and be operated within designated operational limits;
(b) of suitable composition so that surfaces
that contact components, in-process material or drug products shall not be
reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality or purity of the drug product beyond the desired result;
(c) cleaned and sanitized appropriately prior to each use and;
(d) routinely
inspected, calibrated when necessary or checked to ensure proper performance.
D. Labeling. In
addition to the labeling requirements of the pharmacy’s specific license
classification, the label dispensed or distributed pursuant to a prescription
or medication drug order shall contain the following:
(1) the generic
name(s) or the designated name and the strength of the compounded preparation;
(2) the quantity
dispensed;
(3) the date on which
the product was compounded;
(4) a lot or batch
number, and;
(5) the beyond-use
date after which the compounded preparation should not be used;
(a) in the absence of
stability information applicable for a specific drug in the USP/NF the
preparation shall adhere to the following maximum beyond-use date guidelines:
(i) non-aqueous
liquids and solid formulations (where the manufactured drug product is the
source of active ingredient) 25% of the time remaining until the manufacturer’s
product’s expiration date or six (6) months, whichever is earlier;
(ii) water-containing
formulations (prepared from ingredients in solid form) not later than fourteen
(14) days when refrigerated between 2-8 degrees Celsius or 36-46 degrees
Fahrenheit;
(iii) all other
formulations: intended duration of
therapy or 30 days, whichever is earlier;
(b) beyond-use date limits may be exceeded
when supported by valid scientific stability information for the specific
compounded preparation.
E. Drugs, components and material used in non-sterile
compounding.
(1) Drugs used in non-sterile compounding
shall preferably be a USP/NF grade substance manufactured in a FDA registered
facility.
(2) In the event that USP/NF grade substances
are not available, documentation of stability and purity must be established
and documented.
(3) A pharmacy may not compound a drug product
which has been withdrawn or removed from the market for safety reasons.
F. Compounding process.
The safety, quality and performance of compounded prescriptions depend
on correct ingredients and calculations, accurate and precise measurements,
appropriate formulation conditions and procedures, and prudent pharmaceutical
judgment. Each pharmacy shall develop
and follow written SOP’s based on established compounding procedures as
outlined in chapter 795 of the USP/NF concerning pharmacy compounding of non-sterile
preparations designed to ensure accountability, accuracy, quality, safety, and
uniformity in the compounding process.
G. Quality control.
(1) The safety, quality, and monitoring is
used to insure that the output of compounded drug products for uniformity and
consistency such as capsule weight variations, adequacy of mixing, clarity or
pH of solutions are met. When developing
these procedures, pharmacy personnel shall consider the provisions of Chapter
795 of the USP/NF concerning pharmacy compounding of non-sterile preparations,
chapter 1075 of the USP/NF concerning good compounding practices, and chapter
1160 of the USP/NF concerning pharmaceutical calculations in prescription
compounding. Such procedures shall be
documented and be available for inspection.
(2) Compounding procedures that are routinely
performed, including batch compounding, shall be completed and verified
according to written procedures. The act
of verification of a compounding procedure involves checking to ensure that calculations, weighing and measuring, order of mixing,
and compounding techniques were appropriate and accurately performed.
(3) Unless otherwise indicated or appropriate,
compounded preparations are to be prepared to ensure that each preparation
shall contain not less than 90.0 percent and not more than 110.0 percent of the
theoretically calculated and labeled quantity of active ingredient per unit
volume and not less than 90.0 percent and not more than 110.0 percent of the
theoretically calculated weight or volume per unit of the preparation.
[16.19.30.9
NMAC - N, 09-15-06; A, 06-29-13]