New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 30 - COMPOUNDING OF NON-STERILE PHARMACEUTICALS › Section 16.19.30.9 - OPERATIONAL STANDARDS

Current through Register Vol. 35, No. 13, July 16, 2024
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 veterinary preparations.
(a)
				Preparations for animals may be compounded based on an order or prescription
				from a duly authorized veterinarian.
(b) These preparations are to be handled and
				filled the same as the human prescriptions.
(c) Compounding of drugs for animals must be
				in accordance with the Animal Medicinal Drug Use Clarification Act of 1994 or
				successor Act.
(d) A licensed
				pharmacy may compound veterinary drug preparations in reasonable quantities, in
				accordance with Paragraph (5) of Subsection DDD of
				16.19.8.7
				NMAC to be used by veterinarians in their office for administration to patients
				("office use preparations").
(e)
				Compounded office use preparations may be dispensed by a veterinarian to
				clients only under the following conditions:
(i) a valid veterinarian client patient
				relationship exists;
(ii) the
				patient has an emergency condition that the compounded drug is necessary to
				treat;
(iii) dispensed amount is
				for use in a single course of treatment, not to exceed a 120-hour
				supply;
(iv) timely access to a
				compounding pharmacy is not available; and
(v) the medication is not a controlled
				substance;
(f)
				Compounded controlled substance veterinary office use preparations may be
				distributed by a pharmacy under the following conditions:
(i) the preparation is not readily available
				from an outsourcing facility;
(ii)
				ordering and distribution occur in compliance with applicable state and federal
				law;
(iii) the pharmacy shall be
				registered with the DEA as a manufacturer; and
(iv) in addition to other required labeling,
				such preparations shall bear a statement "For administration only. Not for
				dispensing or resale."
(g) Prohibition on wholesaling:
(i) Office use preparations will not be
				distributed by a person other than the pharmacy that compounded such veterinary
				drug preparations.
(ii) This does
				not prohibit administration or dispensing pursuant to a prescription drug order
				executed in accordance with federal and state law; and the conditions of this
				Paragraph (4).
(h)
				Providing samples of compounded veterinary preparations is
				prohibited.
(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.