New Mexico Register / Volume XXXVI, Issue 18 / September 23, 2025

 

 

NOTICE OF REGULAR BOARD MEETING AND RULE HEARING

 

The New Mexico Board of Pharmacy will convene on October 23rd and 24th, 2025 at 9:00 a.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 a 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/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 must submit documentation for presentation; via fax (505) 222-9845, mail or email to the Board Administrator, at the general e-mail pharmacy.board@rld.nm.gov at least one week in advance of the scheduled meeting.

 

Interested persons wishing to comment on proposed language regarding rule hearings may submit documentation for presentation prior to the hearing; via fax (505) 222-9845, mail or email to the Board Administrator, at the general e-mail pharmacy.board@rld.nm.gov in advance of the scheduled meeting.  Public comment is also allowed during the rule hearing.

 

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, or if you are in need of a translator to attend or participate in the hearing or meeting, please contact Board Administrator at 505-222-9830 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 at 505-222-9830 or e-mail pharmacy.board@rld.nm.gov if a summary or other type of accessible format is needed.

 

The full text of Proposed Rule Amendments for Rule Hearing on October 23rd, 2025, at 9:10 a.m. is available for each rule via the hyperlinks below, agenda hyperlinks, and Sunshine Portal notice hyperlinks.  If you are unable to access the full text of Proposed Rule Amendments via the links provided, please contact pharmacy.board@rld.nm.gov for a copy.

 

Short explanation of the Purpose of Proposed Rule Amendments: see below.

 

16.19.7 NMAC – HOSPITAL PHARMACIES

 

Section 8, the number of competent and qualified personnel assisting the pharmacist in charge shall be determined by the same.  Remove requirement for the board or its agent to review pharmacy policy and procedure manual changes.

 

Section 9, remove provision detailing original or direct copy of the medication order, consistent with contemporary technological standards.  For specialty designation pharmacy, replace yearly with initial license application and specify that blueprints will be provided, rather than photos and a drawing.   Add allowance for pharmacist intern to be present in the pharmacy to perform clerical tasks or drug regimen reviews when the pharmacist is not in the facility.  This change can improve training opportunities for interns, while allowing for increased utilization of available resources to support pharmacy operations and patient care. 

 

Section 10, minimum square footage of a pharmacy service unit does not include space for sterile compounding.  Addition of a pharmacy service unit in a hospital requires submission of plans for board approval and inspection. 

 

Section 11, Subsection D, simplify by replacing “inpatients and outpatients” with “patients” and “inpatient” with “patient.”  Subsection E, schedule III-V controlled substance records must be kept separate or readily retrievable (rather than just schedule IV).  Subsection F, remove reference to inpatient distribution records. Subsection J, remove requirement for listing drugs in the policy and procedure manual, and correct grammar.  Subsection M, allow designee for control of security/access to automated pharmacy systems.  Subsection N, the contract will outline the services provided in outsourcing of pharmaceutical services and be incorporated into the policy and procedure manual.  Records of pharmaceuticals transferred will be kept.  Remove requirement for documentation of services provided.

 

Section 12, remove list of drug information requirements.  Required reference materials are commensurate with scope of practice. 

 

Section 13, administrative update. 

 

Section 15, the addition of an in-house clinic will require submission of plans to the board for approval and inspection prior to authorization.

 

The purpose of these changes is to remove unnecessary provisions, reduce administrative burden, correct grammar, and update requirements and allowances consistent with contemporary standards.

 

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 hospital pharmacies and the drug rooms of hospitals and the inspection of their facilities and activities.

 

https://www.rld.nm.gov/wp-content/uploads/2025/09/16.19.7-NMAC-Clean-Copy-Amend-Short-October-2025-hearing.pdf

 

16.19.9 NMAC - MINIMUM STANDARDS FOR MANUFACTURERS AND REPACKAGING FIRMS

 

Section 1, administrative updates.

 

Section 3, correct citation format.

 

Section 7, correct terms.

 

Section 8, minimum standards - Subsection A, change conformance with required United States Pharmacopeia chapter from 1141 to 1197 (packaging, storage and distribution to risks and mitigation strategies for the storage and transportation of finished drug products).  Paragraph 4, administrative update.  Subsection B, require equipment, accessories and space as necessary for the manufacture of radiopharmaceuticals as specified by delineated agencies.  Remove list of minimum equipment and accessory standards.  

 

Section 9, licensure or registration, remove reference to wholesale distributor, administrative update, delete paragraphs D-F and re-letter accordingly.

 

Section 14, administrative update.

 

The purpose of the proposed changes is to update, correct, remove unnecessary provisions, and minimize administrative burden

 

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 and for the inspection of their facilities and activities.  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.

 

https://www.rld.nm.gov/wp-content/uploads/2025/09/16.019.0009-Clean-Copy-Amend-Short-October-2025-hearing.pdf

 

16.19.18 NMAC – NUCLEAR PHARMACY

 

Section 1, administrative update

 

Section 7, remove requirement that qualified nuclear pharmacist be currently certified as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties.

 

Section 9, a nuclear pharmacy shall have the minimum equipment, accessories and space as necessary for the manufacture of radiopharmaceuticals as specified by delineated agencies.  Delete list of required equipment.

 

The purpose of the updates is to remove unnecessary provisions and minimize administrative burden.

 

STATUTORY AUTHORITY:  Paragraph (1) of Subsection (A) of Section 61-11-6 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.  Paragraph (3) of Subsection (A) of Section 61-11-6 NMSA 1978 directs the Board to provide for the registration and annual renewal of licenses of pharmacists.  Pursuant to Paragraph (6) of Subsection (A) of Section 61-11-6 NMSA 1978, the Board is authorized to provide for the licensing of retail pharmacies, nonresident pharmacies and wholesale drug distributors and to provide for the inspection of their facilities and activities.

 

https://www.rld.nm.gov/wp-content/uploads/2025/09/16.019.0018-Clean-Copy-Amend-Short-October-2025-hearing.pdf

 

16.19.36 NMAC - COMPOUNDED STERILE PREPARATIONS

 

Section 10, routine viable surface sample testing may be performed onsite by appropriately trained personnel.

 

Section 16, compounding veterinary preparations, add allowance for distribution of limited quantities of sterile compounded preparations for office use under specified conditions.

 

The purpose of the changes is to allow trained personnel to perform routine required sampling, and for availability of office use sterile compounded veterinary preparation for certain circumstances, to improve timely treatment access.

 

STATUTORY AUTHORITY:  Paragraph (6) of Subsection A of Section 61-11-6 NMSA 1978 authorizes the board of pharmacy to provide for the licensing of all places where dangerous drugs are stored, dispensed, distributed or administered and for the inspection of their facilities and activities.  Paragraph (7) of Subsection A of 61-11-6 NMSA 1978 authorizes the board to enforce the provisions of all laws of the state pertaining to the practice of pharmacy and the manufacture, production, sale or distribution of drugs and their standards of strength and purity.

 

https://www.rld.nm.gov/wp-content/uploads/2025/09/16.019.0036-clean-copy-amend-short-october-2025-hearing.pdf

 

Disciplinary Hearing(s):

There are no disciplinary hearings scheduled at time of submission for publication.

 

If additional 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:   September 23, 2025

Published in Albuquerque Journal:   September 18, 2025