N.M. Admin. Code § 16.19.37.7

Current through Register Vol. 35, No. 21, November 5, 2024

Section 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.

N.M. Admin. Code § 16.19.37.7

Adopted by New Mexico Register, Volume XXVI, Issue 22, November 30, 2015, eff. 12/13/2015