TITLE 16 OCCUPATIONAL AND PROFESSIONAL LICENSING

CHAPTER 19 PHARMACISTS

PART 16 SAMPLE DRUG DISTRIBUTION

16.19.16.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505) 841-9102.

[02-15-1889...02-15-96; 16.19.16.1 NMAC - Rn, 16 NMAC 19.16.1, 03-30-02]

16.19.16.2 SCOPE: All individuals and entities that distribute, furnish or supply pharmaceutical product samples.

[02-15-96; 16.19.16.2 NMAC - Rn, 16 NMAC 19.16.2, 03-30-02]

16.19.16.3 STATUTORY AUTHORITY: Section 61-11-6.A.(1) NMSA 1978 authorizes the Board of Pharmacy to adopt, regularly review and revise rules and regulations necessary to carry out the provisions of the Pharmacy Act. Section 61-11-6.A.(7) gives the Board authority to enforce the provisions of all laws of the state pertaining to the distribution of drugs.

[02-15-96; A, 04-30-98; 16.19.16.3 NMAC - Rn, 16 NMAC 19.16.3, 03-30-02]

16.19.16.4 DURATION: Permanent.

[02-15-96; 16.19.16.4 NMAC - Rn, 16 NMAC 19.16.4, 03-30-02]

16.19.16.5 EFFECTIVE DATE: February 15, 1996, unless a different date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the New Mexico Administrative Code (NMAC) effective 2-15-96.

[02-15-96; A, 04-30-98; 16.19.16.5 NMAC - Rn, 16 NMAC 19.16.5, 03-30-02]

16.19.16.6 OBJECTIVE: The objective of Part 16 of Chapter 19 is to protect the health and safety of New Mexico citizens by regulating the distribution of pharmaceutical samples not intended for resale.

[02-15-96; 16.19.16.6 NMAC - Rn, 16 NMAC 19.16.6, 03-30-02]

16.19.16.7 DEFINITIONS:

A. Sample - means a drug which is not intended to be sold and is intended to promote the sale of the drug.

B. [Reserved]

[03-07-80...08-27-90; 16.19.16.7 NMAC - Rn, 16 NMAC 19.16.7, 03-30-02]

16.19.16.8 DISTRIBUTION OF PHARMACEUTICAL SAMPLES:

A. No person regulated by this Board including a person acting as principal or agent (detail person) for a manufacturer, wholesaler, or distributor shall buy, sell, trade, barter or exchange, or offer to buy, sell, trade, barter or exchange:

(1) Pharmaceutical product samples;

(2) Pharmaceutical products sold for export only;

(3) Pharmaceuticals purchased by hospitals, and/or clinics, including agencies of state and local governments for the exclusive use of those institutions and not intended for resale;

(4) Pharmaceutical products donated or supplied at reduced prices to charitable institutions in the United States or abroad for their own institutional use;

(5) Complementary pharmaceutical product trade packages.

B. Sales otherwise permitted by law to affiliated corporations in furtherance of a planned, integrated approach to the delivery of health care within a health care corporate structure and sales by a bona fide group purchasing arrangement to members are not subject to 16.19.16.8 NMAC nor are emergency borrowing/lending between licensed health care facilities.

C. Violations of these regulations is grounds for revocation of licenses or permits issued by the Board of Pharmacy.

[03-07-80...08-27-90; 16.19.16.8 NMAC - Rn, 16 NMAC 19.16.8, 03-30-02]

HISTORY OF 16.19.16 NMAC:

Pre-NMAC History: The material in this part was derived from that previously filed with the State Records Center and Archives:

Regulation No. 16, Sample Drug Distribution, 2-2-87.

Regulation No. 16, Sample Drug Distribution, 7-27-90.

History of Repealed Material: [RESERVED]

Other History: 16 NMAC 19.16, Pharmacists - Sample Drug Distribution, filed 02-02-96, reformatted and renumbered to 16.19.16 NMAC, Sample Drug Distribution, effective 03-30-2002.