New Mexico Administrative Code

A. Drug warehouses shall establish and maintain inventories and records of all transactions regarding receipt and distribution of other disposition of prescription drugs. These records shall be maintained at the clinic, hospital or pharmacy and must include the following informat…

A. Drug warehouses shall establish, maintain and adhere to written policies and procedures which shall be followed: (1) for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures; (2) for identifying, recording and rep…

Drug warehouses shall establish and maintain lists of officers, directors, managers and other persons in charge of drug warehouse storage and handling, including a description of their duties and a summary of their qualifications.

Drug warehouses shall operate in compliance with applicable federal, state and local laws and regulations. A. Drug warehouses shall permit board authorized personnel and authorized federal, state and local law enforcement officials to enter and inspect their premises, delivery ve…

A. Every clinic, hospital or pharmacy requiring off-site storage of drugs shall license with the board by application and provide information required by the board on an application approved by the board, including but not limited to: (1) all trade or business names used by the l…

A. The board shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in warehousing of prescription drugs within the state: (1) any conviction of the applicant under any federal, state or local laws relating to drug samples, whole…

This section applies to all licensed clinics, hospitals and pharmacies.

Section 61-11-6(A)(6) NMSA 1978 authorizes the board of pharmacy to provide for the licensing of all places where dangerous drugs are stored or administered and for the inspection of their facilities and activities. Section 61-11-14(B)(10) NMSA 1978 authorizes the board to issue …

Permanent.

November 15, 2010, unless a different date is cited at the end of a section.

The objective of Part 35 of Chapter 19 is to establish standards for the safe and competent storage of pharmaceutical products in facilities located off-site from the licensed clinic, hospital or pharmacy.

"Drug warehouse" means an off-site physical storage location of a clinic, hospital or pharmacy currently licensed by the New Mexico board of pharmacy. Dangerous drugs may be stored for the use of the licensed clinic, hospital or pharmacy.

A. All facilities at which prescription drugs are stored shall: (1) be of suitable size and construction to facilitate cleaning, maintenance and proper operations; (2) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space,…

All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or in compliance with standards in the current edition of an official compendium, such as United States phar…

Regulation and Licensing Department - Board of Pharmacy.

Each facility compounding sterile preparations shall have sufficient equipment for the safe and appropriate storage, compounding, packaging, labeling, dispensing and preparation of compounded sterile preparations drugs and parenteral preparations appropriate to the scope of pharm…

A. Written policies, procedures and SOPs consistent with USP/NF <797> (General Chapter <797> Pharmaceutical Compounding-Sterile Preparations) standards as well as those required below, must be established, implemented, followed by facility personnel, and available for inspection …

The compounded sterile preparations facility is required to maintain patient's records which include but are not limited to the following. A. Prescription records or provider orders including the original prescription or original provider order, refill authorization, alterations …

All personnel, including pharmacists, pharmacists who supervise compounding personnel (including designated persons), pharmacists interns and pharmacy technicians, shall have completed didactic and experiential training with competency evaluation through demonstration and testing…

A. The pharmacist shall maintain documentation that the patient has received training consistent with Subsection F of 16.19.4.16 NMAC. B. The facility shall provide a 24-hour toll free telephone number for use by patients of the pharmacy. C. There shall be a documented, ongoing q…

A. There shall be a documented, ongoing performance improvement control program that monitors personnel performance, equipment, and facilities:(1) all aspects of sterile product preparation, storage, and distribution, including details such as the choice of cleaning materials and…

All facilities as defined in Paragraph (1), (2), (5) through (11) and (15) of Subsection B of 61-11-14 NMSA 1978, and all persons or entities that own or operate, or are employed by a facility for the purpose of providing pharmaceutical compounded sterile preparations or services…

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)…

Permanent.

June 28, 2014, unless a different date is cited at the end of a section.

The objective of Part 36 of Chapter 19 is to establish standards to ensure that the citizens of New Mexico receive properly compounded contaminant-free sterile preparations properly compounded in accordance with all applicable USP/NF General Chapters numbered below 1000.

A. "Air changes per hour" (ACPH) means the number of times a volume of air equivalent to the room passes through the room each hour. B. "Anteroom" means an ISO Class 8 or cleaner area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP lab…

A. All facilities compounding sterile preparations must designate a pharmacist in charge of operations who is licensed as a pharmacist in the state of residence of the facility. B. The pharmacist-in-charge (or consultant pharmacist, for in-state clinics) is responsible for:(1) th…

A. The room or area in which compounded sterile preparations (CSP's) are prepared: (1) must be physically designed and environmentally controlled to meet standards of compliance as required by USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparatio…

Regulation and Licensing Department - Board of Pharmacy.

A. PHARMACIST IN CHARGE. (1) Any drugs compounded in an outsourcing facility or dual purpose facility licensed pursuant to this rule shall be compounded by or under the direct supervision of a licensed pharmacist and in accordance with all applicable federal and state laws. (2) A…

All outsourcing facilities, resident and nonresident, and all persons or entities that own or operate, or are employed by, an outsourcing facility for the purpose of providing pharmaceutical products or services.

Section 61-11-6 A(6) NMSA 1978 authorizes the board of pharmacy to provide for the licensing of drug manufacturers and for the inspection of their facilities and activities; and to enforce the provisions of all state laws pertaining to the practice of pharmacy and the manufacture…

Permanent.

December 13, 2015, unless another date is cited at the end of a section.

The objective of 16.19.37 NMAC is to establish standards for the safe and competent manufacture and distribution of drugs by outsourcing facilities.

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 …

A. Any outsourcing facility that is engaged in the compounding of sterile drugs in this state shall be registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act and be licensed as an outsourcing facility in this state. B. Any nonresident outsourcing fac…

The following minimum standards shall apply to all outsourcing facilities and dual purpose facilities for which licenses have been issued by the board: A. All drugs and chemicals used in the manufacturing process or held for sale shall conform to the Drug, Device and Cosmetic Act…

Board of Pharmacy.

A. Continuing pharmacy education (CPE) shall include study in one or more of the general areas of socioeconomic and legal aspects of health care; the properties and actions of drugs and dosage forms; etiology; characteristics and therapeutics of the disease state, or such other s…

A. Duties and responsibilities: (1) To abide by the code of ethics of the American Society of Consultant Pharmacists. Must be qualified to practice as a consultant pharmacist and is to be aware of all federal and state drug laws, rules and regulations related to pharmacy services…

A. Definitions: For the purpose of this section: (1) Chemical dependence - repeated use of alcohol or drugs culminating in a pattern of chemical need. (2) Disciplinary authority - the board which may discipline pharmacists. (3) Diversion - illicit dispensing, distribution or admi…

Any registrant or licensee shall report in writing any change of address or employment to the Board within ten (10) days.

Any pharmacist who maintains competency through the development and maintenance of knowledge, skill and aptitude, to ensure continuing competence as a pharmacy professional, and is able to demonstrate to the board said competence in the practice of pharmacy shall be issued an act…

A. A pharmacist not engaged or ceasing to be engaged in the practice of pharmacy for two or more years shall be issued an inactive status license upon proper application and payment of fees. B. Pursuant to Section 61-11-13.B, an inactive status pharmacist applying for an active s…

A. The following responsibilities require the use of professional judgment and therefore shall be performed only by a pharmacist or pharmacist intern: (1) receipt of all new verbal prescription orders and reduction to writing; (2) initial identification, evaluation and interpreta…

A. Purpose: The purpose of these regulations is to implement the Pharmacist Prescriptive Authority Act, Sections 61-11B-1 through 61-11B-3 NMSA 1978 by providing minimum standards, terms and conditions for the certification, registration, practice, and supervision of pharmacist c…

A. Purpose: The purpose of these regulations is to implement the Pharmacist Prescriptive Authority Act, Sections 61-11B-1 through 61-11B-3 NMSA 1978 by providing minimum standards, terms and conditions for the certification, registration, practice, and supervision of pharmacist c…