N.M. Admin. Code § 16.19.6.18

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

Section 16.19.6.18 - LABELING OR TO LABEL

As used in Section 61-11-2 of the Pharmacy Act "labeling" or "to label". The act of affixing, applying or attaching a display of written, printed or graphic matter upon or in the immediate container of any human use drug, repackaging or dispensed on the order of a practitioner, shall be defined as "labeling" or "to label", and is a function restricted to registered pharmacists and registered pharmacist interns as required by Section 61-11-21 of the Pharmacy Act, except that the pharmacist labeling requirement shall not apply to Board Regulation Article 15. As used in Section 26-1-11 Drug and Cosmetic Act "label" or "labeling" means the manufacturer or repackagers label required on the commercial container, when such substance is offered for sale, or distributed by the manufacturer or repackager.

A. PRESCRIPTION DRUG DISPENSING CONTAINER REQUIREMENTS: Prescription drug dispensing container requirements to be included on the label by the manufacturer. Both pharmacist and drug manufacturer are responsible for packaging a drug product in accordance with packing requirements specified in the monographs for drug products recognized in the official compendium as defined in 26-1-2 L. All drug products introduced or delivered into interstate commerce after August 27, 1978, must provide information for the pharmacist to be utilized when dispensing the drug to maintain the identity, strength, quality and purity of the product. The compendia standards for proper dispensing containers became effective on April 1, 1977, and applies to both containers used by manufacturers and containers used by pharmacists for dispensing compendia drugs. Manufacturers of non-compendia drug products must use terminology defined in an official compendium to describe a suitable container for dispensing the product. Proper container descriptions include standards of tightness of seal (well-closed or tight), light-resistant, and moisture permeability and other special instruction such as "Keep in a cold place, "Avoid exposure to excessive heat", etc.

B. DISPENSING CONTAINER INFORMATION: The label attached to the dispensing container shall identify the contents by generic or trade name, or a compounded prescription containing more than three drugs or trade name products, may be labeled "Compound" at the discretion of the pharmacist or prescribing physician, and shall contain the expiration date, per USP/NF's guidelines, as well as the quantity dispensed. This information required by NMSA Drug and Cosmetic Act 26-1-16 B; except, to those instances where the prescribing practitioner specifically requests that such information be omitted from the label.

N.M. Admin. Code § 16.19.6.18

16.19.6.18 NMAC - Rp, 16 NMAC 19.6.18, 03-30-02