New Mexico Administrative Code

Permanent.

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.

The objective of Part 14 of Chapter 19 is to establish mandatory controls and performance standards for health care devices so as to minimize the risk of injury from the distribution and use of adulterated or misbranded devices, and to establish standards for the repackaging and …

A. "Device", as used in the New Mexico Drug and Cosmetic Act, is any health care product that does not achieve any of its principal intended purpose through chemical action within or on the body of man or other animal and which is not dependent upon being metabolized for achievem…

Three regulatory classes are established based on the extent of control necessary to ensure safety and effectiveness of each device: A. Class I -- General Controls (1) prohibiting adulteration or misbranding (2) requiring federal registration and listing by the manufacturer (3) r…

A device may be considered to be adulterated: A. It is subject to a performance standard and does not comply with all requirements of such standard. B. Class II device FDA pre-market approval is not completed. C. It is a banned device. D. It is in violation of good manufacturing …

Regulation and Licensing Department, Board of Pharmacy, Albuquerque NM.

A. All such drugs shall be labeled by the licensed retail distributor as follows: (1) name and address of the retail distributor; (2) consecutively numbered prescription or order number; (3) date of the prescription, or in the case of a refill, the date of the refill of the origi…

The package insert shall be left in the dispensed container, unless the prescribing veterinarian indicates on the prescription that it be removed by the dispenser.

A. Labels as required in Section 10 of this Regulation shall be placed on each drug container when quantity is in less than case lot distribution. B. If the prescriber orders in quantities of case lot or carton, which is the same strength and dose units, the label shall be placed…

Dangerous veterinary use drugs which are distributed at retail without the label required in Section 10 of this regulation shall be deemed to be misbranded under the provisions of the New Mexico Drug and Cosmetic Act and the federal law.

A. A prescription or order of a licensed veterinarian shall not be refilled without the authorization of the prescribing veterinarian. If such authorization is other than written authorization, indicate the information on the back of the original order or prescription with the da…

Prescriptions or orders must be consecutively numbered and filed by the retail veterinary drug distributor. Such files shall be kept for three years.

All procurement invoices and distribution records for dangerous veterinary drugs shall be kept for three years and shall be open to the inspection by an enforcement officer of the State.

A. All stock or inventory of dangerous veterinary drugs shall be maintained in an area not accessible to the public. Such area shall provide for the proper storage of drugs with adequate ventilation, lighting, temperature controls and refrigeration as may be required. B. Purchase…

Written permission shall be obtained from the Board before any disposal or sale, transfer, or other removal of a major part or all the inventory, not in the ordinary course of business by a licensed retailer of veterinary dangerous drugs.

When a retail veterinary drug distributor is involved in a robbery, fire, flood or any unusual event in which dangerous veterinary drugs might be missing or damaged, the owner shall immediately file with the Board, a signed statement of the circumstances of such occurrence and ev…

All retail veterinary drug distributors.

Any retail distributor licensed by the Board to dispense veterinary prescription drugs is required to have a consultant pharmacist. A. Consultant pharmacists to retail distributors of veterinary prescription products are required to visit the facility every other month. Consultan…

Section 61-11-14.B. (13) NMSA 1978 authorizes the board of pharmacy to issue drug permits for wholesalers, retailers and distributors of dangerous drugs limited to veterinary use. Section 26-3-3(A) NMSA 1978 (the Drug Product Selection Act or "DPSA") authorizes pharmacists to dis…

Permanent.

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.

The objective of Part 15 of Chapter 19 is to establish standards to be followed by retailers and distributors for the safe and competent delivery, distribution, and disposal of dangerous drugs limited to veterinary use and to carry out the purpose of the Drug Product Selection Ac…

A. "Limited licensure for retailers of veterinary drugs" means a license issued in accordance with the Pharmacy Act 61-11-14.B (13), which authorizes licensees to retail dangerous drugs limited to veterinary use, in accordance with the labeling provisions of the Drug and Cosmetic…

Retail distribution of veterinary drugs which by federal law require the manufacturer to label the following legend: "CAUTION: Federal law restricted this drug to use or on the order of a licensed veterinarian" shall be as follows: A. shall be sold at retail by the licensee or an…

All dangerous drugs distributed at retail on the order of a licensed veterinarian by the limited retail veterinary drug distributor shall be sold in the original, unbroken manufacturer's containers. A. Upon receipt of a prescription for an animal drug, a pharmacist may dispense a…

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

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

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 sta…

Permanent.

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.

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.

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

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…

Regulation and Licensing Department -- Board of Pharmacy.

All individuals or entities who sell, dispose of or possess any dangerous drug, including institutions of higher education, private organizations, or other applicants who do not possess a pharmacy license, and are not subject to licensure with any professional licensing board or …

Section 26-1-18 of the New Mexico Drug, Device and Cosmetic Act, Chapter 26, Article 1 NMSA 1978, authorizes the board of pharmacy to promulgate regulations for the efficient enforcement of the act and to declare, by regulation, a substance a dangerous drug. Section 61-11-6.A(6) …

Permanent.

February 15, 1996, unless a later date is cited at the end of a section.

The objective of Part 17 of Chapter 19 is to provide notice of the board's designation of particular substances as dangerous drugs and for the licensure of dangerous drug researchers. A dangerous drug researcher will be allowed to possess dangerous drugs for the purpose of conduc…

A. "Board" means the New Mexico board of pharmacy. B. "Dangerous Drug" as defined in the New Mexico Drug, Device and Cosmetic Act, Subsection F of Section 26-1-2 NMSA 1978. (1) The following substance(s) has(have) been declared by the N.M. board of pharmacy as "Dangerous Drugs" i…

A. Authorized persons to be licensed: public agencies, institutions of higher education and private organizations, or individuals for the purpose of conducting research, demonstration or special projects with the use of a dangerous drug. B. The person applying for licensure must …

Regulation and Licensing Department - Board of Pharmacy.

A. Medications shall be dispensed from a nuclear pharmacy in accordance with the requirements contained in 16.19.6 NMAC, except as provided for in this section. B. A radiopharmaceutical shall be dispensed only to a licensed practitioner authorized by the Nuclear Regulatory Commis…

All individuals and entities that provide radiopharmaceutical products or services or engage in the practice of nuclear pharmacy, including owners of nuclear pharmacies.

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 direct…

Permanent.

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.

The objective of Part 18 of Chapter 19 is to recognize and provide for the specialization of nuclear pharmacy and to protect the public health and welfare of New Mexico citizens by establishing standards for the practice.

A. The "Practice of Nuclear Pharmacy" means a patient-oriented service that embodies the scientific knowledge and professional judgement required to improve and promote health through the assurance of the same and efficacious use of radiopharmaceuticals and other drugs. B. "Nucle…