New Mexico Administrative Code

A. The pharmacist-in-charge is responsible for provision of drug information to the staff and patients of the healthcare facility. The pharmacist-in-charge shall be responsible for providing in-service education to the facility's professional staff. In-service activities shall be…

A. The pharmacist in conjunction with practitioners, nurses and other professional staff shall develop a procedure for the review and reporting of significant adverse drug reactions and medication errors. These events shall be reported to the prescribing practitioner and the appr…

A. The pharmacist shall conduct, participate in and support medical and pharmaceutical research appropriate to the goals, objectives and resources of the facility. B. There shall be a pharmacist member on the facility's Institutional Review Board, or its equivalent. The pharmacis…

In-house clinics owned and operated by the institution must meet regulations set forth in Part 10 "Limited Drug Clinics" and Part 4 "Pharmacists". The clinic may operate under the license of the hospital pharmacy and is not required to obtain a separate license or permit from the…

A. In order to improve continuity of care by avoiding temporary disruption in a patient's prescribed medication regimen upon discharge from hospitalization, and to decrease medication waste (as in the case of a partially used multidose container, such as an inhaler), dispensing b…

All pharmacies, hospital-based skilled nursing facilities and all drug rooms maintained in hospitals.

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.

Permanent.

August 16, 1999, unless a later date is cited at the end of a Section or Paragraph.

The objective of Part 7 of Chapter 19 is to establish standards for the safe and competent delivery of quality pharmaceutical care.

A. "Automated Medication Management System" means automated devices that compound, measure, count, or package and deliver a specified quantity of dosage units for a designated drug product and which collects, controls and maintains all transaction information. B. "Bar-Code" means…

A. There shall be a pharmacist-in-charge of the hospital pharmacy. The pharmacist in charge may be employed part-time or full-time as the activity of service requires. When services are provided on a part-time basis, the pharmacist-in-charge or designated pharmacist shall visit t…

A. The hospital pharmacy shall be enclosed and locked if a pharmacist is not present in the facility. Adequate security systems shall be maintained and be consistent with the security plan of the facility. B. The pharmacist-in-charge shall control access to the pharmacy and devel…

Regulation and Licensing Department - Board of Pharmacy.

A. The board shall prohibit a person from receiving or maintaining licensure for wholesale distribution if the person: (1) has been convicted of any felony for conduct relating to wholesale distribution, any felony violation of Subsection (i) or (k) of Section 301, or any felony …

As a condition of receiving and retaining a wholesale drug distributor license, the licensee shall require each person employed in any prescription drug wholesale distribution activity to have education, training, and experience, or any combination thereof, sufficient for that pe…

The board shall have the authority to suspend or revoke any licenses granted under this part on the grounds established by law or regulations; and may impose fines or civil penalties if allowed by law.

A. Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall: (1) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; (2) have storage areas designed to provide …

A. Every third-party logistics provider, wherever located, who engages in providing third-party logistics into, out of, or within this state must be licensed by the board in accordance with the laws and regulations of this state before engaging as a third-party logistics provider…

A. Every third-party logistics provider, located in New Mexico or located in another state and not licensed as a third-party logistics provider by the FDA, who engages in third-party logistics activities involving product shall be licensed with the board, by submitting an applica…

A. The board will not license a third-party logistics provider when the FDA has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and published notice thereof. B. The board shall consider, at a minimum, the following …

As a condition of receiving and retaining a third-party logistics provider license, the licensee shall require each person employed in any prescription drug third-party logistics activity to have education, training, and experience, or any combination thereof, sufficient for that…

A. Reporting: Each facility of a third-party logistics provider shall comply with the FDA annual reporting requirements. B. Storage practices, facilities: All third-party logistics provider facilities at which prescription drugs are stored, warehoused, handled, held, or displayed…

A. Every repackager, wherever located, who engages in distribution into, out of, or within this state must be licensed by the board in accordance with the laws and regulations of this state before engaging in repackaging or distribution of prescription drugs. B. A repackager shal…

All individuals and entities engaged in the wholesale distribution of prescription drugs, including, own-label distributors, private-label distributors, jobbers, brokers, manufacturer's warehouses, distributor's warehouses, chain drug warehouses, wholesale drug warehouses, indepe…

A. Every repackager who engages in the distribution of product shall be licensed with the board by submitting an application and providing information required by the board on an application approved by the board, including:(1) applicant's full name; all trade or business names u…

A. The board shall prohibit a person from receiving or maintaining repackager licensure if the person: (1) has been convicted of any felony for conduct relating to manufacturing or distribution, any felony violation of Subsection (i) or (k) of section 301, or any felony violation…

As a condition of receiving and retaining a repackager license, the licensee shall require each person employed in any repackaging or distribution activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned …

A. Compliance with federal, state, and local law. A repackager shall operate in compliance with applicable federal, state, and local laws and regulations. (1) A repackager shall comply with 16.19.9 NMAC, including operation in compliance with the Federal Food, Drug, and Cosmetic …

A. Product tracing, product identifier, and verification: Manufacturers shall comply with the requirements for tracing products through the distribution system as defined in Sections 353 and 360eee, et seq., of the DSCSA, 21 U.S.C. 301, et seq., and successor FDA regulations, wit…

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 Sec…

Permanent

November 28, 2017, unless a different date is cited at the end of a section.

The objective of Part 8 of Chapter 19 is to implement the Federal Food, Drug and Cosmetic Act, 21 United States Code (U.S.C.) 351 et seq., as amended by the Drug Supply Chain Security Act of 2013 (Pub. L. 113-54), by providing minimum standards, terms and conditions for the licen…

A. "Adulterated" a drug or device shall be deemed to be adulterated if it: (1) consists in whole or part of any filthy, putrid, or decomposed substance; (2) has been produced, prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, o…

A. Every wholesale drug distributor, wherever located, who engages in wholesale distribution into, out of, or within this state must be licensed by the board in accordance with the laws and regulations of this state before engaging in wholesale distribution of prescription drugs.…

A. Every wholesale distributor who engages in the wholesale distribution of drugs shall be licensed with the board by submitting an application and providing information required by the board on an application approved by the board including: (1) applicant's full name; all trade …

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

Labels for legend drugs in package form shall conspicuously state the name and place of business of the manufacturer of the finished dosage form and the name and place of business of the packer or distributor.

Where the manufacturer of the finished dosage form and the packer or distributor are the same person, only the name and place of business of such persons are required to be on the labels, no qualifying language is necessary.

Where the manufacturer of the finished dosage form and the packer or distributor are different persons, the labels shall contain qualifying language that states the connection such persons have with the drugs: i.e., "Manufactured by ________, distributed by _________, "Manufactur…

In the case of a corporation, only the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation shall be required. In the case of an individual partnership or association, the name under which the business is conducted sha…

If a person manufactures, packs or distributes a drug at a place other than his principle place of business, the label may state the principle place of business in lieu of the actual place where such drug is manufactured or packed or is to be distributed, unless such statement wo…

All manufacturers, packagers and distributors, other than wholesalers, of drugs, including radioactive pharmaceuticals.

Section 61-11-6 A(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. Section 61-11-6(A) NMSA 1978 authorizes the Board to enforce the provisions of all state laws pertaining to t…

Permanent.

February 15, 1996, unless another date is specified at the end of a section.

The objective of Part 9 of Chapter 19 is to establish standards for the safe and competent manufacture, packaging, repackaging and distribution of drugs, including radioactive pharmaceuticals.

For the purpose of defining Section 26-1-11 A(3) NMSA Comp. the following definitions apply: A. "Manufacturer" means the steps in the preparation, propagation, processing or compounding of a drug - the making by chemical, physical, biological or other procedures of any articles w…