N.M. Admin. Code § 16.19.30.7 - DEFINITIONS
In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.
A.
"Active
pharmaceutical ingredient (API)" any substance or mixture of substances
intended to be used in the compounding of a drug preparation, thereby becoming
the active ingredient in that preparation and furnishing pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment,
or prevention of disease in humans and animals or affecting the structure and
function of the body.
B.
"Beyond-use date (BUD)" the date after which a compounded
preparation should not be used and is determined from the date the preparation
was compounded.
C.
"Component" any ingredient intended for use in the compounding of
a drug product, including those that may not appear in such product
labeling.
D.
"Compounding" the preparation, mixing, assembling, packaging, or
labeling of a drug or device (reconstitution of commercial products is not
considered compounding for purposes of this article).
(1) as the 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 orders based upon a history of receiving valid prescriptions
issued within an established practitioner-patient-pharmacist relationship in
the course of professional practice;
(3) reconstitution of commercial products is
not considered compounding for purpose of this article.
(4) the addition of a flavoring agent to a
conventionally manufactured product is not considered compounding as long as
the following conditions are met:
(a) the
flavoring agent is inert, nonallergenic, and produces no effect other than the
instillation or modification of flavor;
(b) the flavoring agent does not alter a
medication's concentration beyond USP's accepted level of variance;
(c) the addition of flavoring agent(s) is
documented in the prescription record.
E.
"FDA" Food and Drug
administration.
F.
"SOP's" standard operating procedures.
G.
"USP/NF" the current edition
of the United States Pharmacopeia/National Formulary.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.