N.M. Admin. Code § 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 defnition of
drugs and includes manipulation, sampling or control procedures resulting in
the fnished 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.
"Nonresidentoutsourcing facility" means any outsourcing facility
located outside New Mexico, that ships, mails or delivers, in any manner,
prescription drugs into New Mexico.
J.
"Outsourcingfacility" 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 incharge" 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 fnished
dosageform" 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.
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.