New Mexico Register / Volume XXXIV, Issue 15 / August 15, 2023

NOTICE OF INTERIM REGULAR BOARD MEETING AND RULE HEARING

The New Mexico Board of Pharmacy will convene on September 15^th at 1:00 p.m. and continue until finished in the Board of Pharmacy Conference Room located at 5500 San Antonio Dr., NE, Albuquerque, NM 87109 for the purpose of conducting an interim regular board meeting and rule hearing.

The agenda is posted 72 hours prior to the scheduled meeting. You may view and download a copy of the agenda through the board’s website: https://www.rld.nm.gov/boards-and-commissions/individual-boards-and-commissions/pharmacy/pharmacy-board-information/pharmacy-board-meetings/. All proposed language regarding rule hearings is linked to the Agenda, the Notice to the Public on our website and the New Mexico Sunshine Portal.

Individuals petitioning the board regarding requests/waivers and/or interested persons wishing to comment on proposed language regarding rule hearings must submit documentation for presentation; via fax (505) 222-9845, mail or email to the Board Administrator, Davilyn Valencia at the general e-mail pharmacy.board@rld.nm.gov in advance of the scheduled meeting, as public comment is allowed during the rule hearing.

The board may go into Executive Session to discuss items pursuant to Section 10-15-1H(1), Section 10-15-1H(2), Section 10-15-1H(3) or Section 10-15-1H(7) of the Open Meeting Act. Agenda items may be executed at any time during the meeting to accommodate hearings.

If you are an individual with a disability who is in need of a reader, amplifier, qualified sign language interpreter, or any other form of auxiliary aid or service to attend or participate in the hearing or meeting, please contact Gabriella Romero 505-222-9835 at least one week prior to the meeting or as soon as possible. Public documents, including the agenda and minutes, can be provided in various accessible formats. Please contact Board Administrator, Davilyn Valencia, at 505-222-9830 or e-mail pharmacy.board@rld.nm.gov if a summary or other type of accessible format is needed.

The Board will address:

All Board Matters:

Rule Hearings: September 15, 2023 at 1:10 p.m.

16.19.6 NMAC – PHARMACIES – Subsections A and C of Section 17 are updated with the removal of terms apothecary and apothecary shop, which terms are no longer restricted in use. Paragraph 5 of Subsection D of Section 23 is updated to allow transfer or forwarding of controlled substance prescriptions as allowed by federal law. Subsection C of Section 24 is updated by striking or renewal of licensure from initial application requirements, and a separate paragraph is added stating that a nonresident pharmacy may apply for license renewal by submitting a renewal application on a form provided by the board. This will help to streamline required renewal application information by eliminating unnecessary information requirements, such as policies and procedures which were approved with the initial application for licensure. Required change of information reporting is updated from 10 to 30 days, aligning with the statute.

STATUTORY AUTHORITY: Paragraph (6) of Subsection A of Section 61-11-6 NMSA 1978 requires that the board of Pharmacy provide for the licensing of retail pharmacies and nonresident pharmacies and for the inspection of their facilities and activities.

16.19.8 NMAC - WHOLESALE DISTRIBUTORS; THIRD-PARTY LOGISTICS PROVIDERS; REPACKAGERS; DRUG SUPPLY CHAIN SECURITY – Subsection A of Sections 9, 11, 15, 17 and 20 are updated by removal of “but not limited to” (leaving just including), and addition of a separate paragraph in Sections 9 and 15 which states that renewal applications shall be on a form furnished by the board. Subsection A of Section 20 is updated with removal of Paragraph 5 (evidence of criminal background checks and fingerprinting for repackager applicant and designated representative). Section 21 is updated with removal of Paragraph C (background check and fingerprint results for repackager personnel), and Section 22 is updated to remove certification requirement for designated representative of a repackager. These changes align requirements for repackager licensure with that of manufacturers, as both are required to be registered with the Food and Drug Administration as a drug establishment under the Federal Food, Drug, and Cosmetic Act.

STATUTORY AUTHORITY: Paragraph (6) of Subsection A of Section 61-11-6 NMSA 1978 directs the board of pharmacy to provide for the licensing of drug manufacturers, repackagers and wholesale drug distributors and for the inspection of their facilities and activities. Paragraph (7) of Subsection A of Section 61-11-6 NMSA 1978 authorizes the board to enforce the provisions of all state laws pertaining to the practice of pharmacy and the manufacture, production, sale or distribution of drugs, cosmetics or poisons, including the New Mexico Drug, Device and Cosmetic Act, Chapter 26, Article I NMSA 1978. Pursuant to Section 26-1-18 of the Drug, Device and Cosmetic Act, the board is authorized to promulgate regulations for the efficient enforcement of the act.

16.19.20 NMAC – CONTROLLED SUBSTANCES – Section 9 is updated by deletion of Subsection D (renewal applications will be mailed…). The board now has an electronic license system, and applications are not mailed out.

STATUTORY AUTHORITY: Section 30-31-11 of the Controlled Substances Act, 30-31-1 through 30-31-42 NMSA 1978, authorizes the board of pharmacy to promulgate regulations and charge reasonable fees for the registration and control of the manufacture, distribution and dispensing of controlled substances. Paragraph (2) of Subsection B of Section 61-11-6 authorizes the board to provide by regulation for the electronic transmission of prescriptions.

16.19.29 – CONTROLLED SUBSTANCE PRESCRIPTION MONITORING PROGRAM Section 7, Subsection F is updated to exclude required dispenser reporting of gabapentin prescriptions, when issued by a veterinarian. Section 8, Subsection B is an administrative update (website domain name).

STATUTORY AUTHORITY: Sections 30-31-1 through 30-31-41 of the Controlled Substance Act NMSA 1978, authorizes the board of pharmacy to promulgate rules and charge reasonable fees regarding controlled substances. Section 30-31-16 of the Controlled Substance Act NMSA 1978 authorizes the board to collect information regarding controlled substances. Paragraph (1) of Subsection A of Section 61-11-6 NMSA, 1978 authorizes the board of pharmacy to promulgate rules to carry out the provisions of the Pharmacy Act, Paragraph (18) of Subsection A of Section 61-11-6 NMSA 1978 authorizes the Board to promulgate rules that prescribe the activities and duties of pharmacy owners and pharmacists in each practice setting. Section 61-11-8 NMSA requires drug records to be kept for all dangerous drugs pursuant to the Pharmacy Act.

Disciplinary Hearing(s): no disciplinary hearings are currently scheduled. If scheduling occurs, the final hearing date and time for each case will be included in the agenda posted to the board’s website at least 72 hours before the meeting.

Executive Director’s Report:

Published in NM Register: August 15, 2023

Published in Albuquerque Journal: August 15, 2023