New Mexico Administrative Code

Permanent.

09-15-06, unless a later date is cited at the end of a section.

The objective of part 30 of chapter 19 is to provide standards for the compounding of non-sterile pharmaceuticals. Pharmacies compounding non-sterile pharmaceuticals shall comply with the requirements of this part in addition to all provisions for their specific license classific…

In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise. A. "Active pharmaceutical ingredient (API)" any substance or mixture of…

A. Pharmacist-in-charge. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding: (1) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary t…

A. General requirements.(1) Non-sterile drug products may be compounded in licensed pharmacies as a result of a practitioner's prescription order based on the practitioner-patient-pharmacist relationship in the course of professional practice. (2) Preparing limited quantities of …

Board of Pharmacy.

A. Emergency provisions for registration by endorsement. Practitioners currently possessing a temporary license issued by a New Mexico regulatory agency and possessing a current drug enforcement administration controlled substance registration in a state in which a federal disast…

A. During a declared civil or public health emergency resulting in unavailable required testing or training, the board may authorize a temporary extension for a: (1) temporary pharmacist license under reciprocity issued pursuant to 16.19.3 NMAC; (2) pharmacy technician registrati…

All pharmacies, resident and non-resident, as defined in Subsections S and Z of Section 61-11-2 NMSA 1978, and all persons or entities that own or operate, or are employed by, a pharmacy for the purpose of providing pharmaceutical products or services. Pharmacists and technicians…

Paragraph (1) of Subsection A of Section 61-11-6 NMAC 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, Sections 61-11-1, 61-11-2, 61-11-4 to 61-11-28 NMSA 1978. Paragraph (…

Permanent.

April 3, 2006, unless a later date is cited in the history note at the end of a Section.

The objective of Part 31 of Chapter 19 is to ensure the safe and competent delivery of quality pharmaceutical products and services to the public by establishing standards for the operation of pharmacies, including but not limited to minimum space requirements and standards for e…

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. A. Emergency situation - and emergency caused by a natural or manmade disaster or any other exceptional situation that causes and extrao…

A. Emergency temporary pharmacist license. In an emergency situation, the board may grant a pharmacist who holds a license to practice pharmacy in another state an emergency temporary pharmacist license to practice in New Mexico. The following is applicable for the emergency temp…

A. Emergency provisions for license by endorsement. Pharmacist currently licensed in a state in which a federal disaster has been declared may be licensed by endorsement in New Mexico during the four months following the declared disaster at no cost with the following requirement…

Regulation and Licensing Department - Board of Pharmacy.

Any person or business pursuant to 26-1-17 of the New Mexico Drug, Device and Cosmetic Act, 30-31-12(A), (B) of the Controlled Substance Act, and 61-11-9, 61-11-11, 61-11-11.1, 61-11-14(A), (B) of the Pharmacy Act.

Section 26-1-18(A) NMSA 1978 authorizes the board to promulgate regulations for the efficient enforcement of the New Mexico Drug, Device and Cosmetic Act (26-1-1 NMSA 1978). The board shall conform the regulations promulgated under the New Mexico Drug, Device and Cosmetic Act, in…

Permanent.

April 30, 2007, unless a later date is cited in the history note at the end of a section.

This regulation established guidelines to waive provisions of the New Mexico board of pharmacy regulations as authorized by law.

"Waive/waivers" means to refrain from pressing or enforcing compliance with certain regulations for the specified period of time provided the health, safety, or welfare of patients and staff are not in danger. Waivers are issued at the sole discretion of the New Mexico board of p…

A. Petition for a waiver must be submitted to the board of pharmacy. Waivers granted by the board are limited to use by the party and business specified in the waiver document and other limitations set forth. Such petitions shall include: (1) name of party; (2) address of the bus…

Regulation and Licensing Department - Board of Pharmacy.

This section applies to hub pharmacies and remote tele-pharmacies. Both the hub pharmacy and remote tele-pharmacy must be located within and licensed by the New Mexico board of pharmacy. The remote tele-pharmacy must be greater than 20 miles from an existing retail pharmacy to qu…

Section 61-11-6.A.(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. Section 61-11-6.A.(1) NMSA 1978 requires the board of pharmacy to adopt, regula…

Permanent.

May 14, 2010, unless a different date is cited at the end of a section.

The objective of Part 33 of Chapter 19 is to ensure the safe and competent delivery of quality pharmaceutical products and the provision of pharmaceutical care to the public by establishing standards for the operation of remote dispensing sites and tele-pharmacy, including but no…

A. "Board" means the New Mexico board of pharmacy. B. "Electronic link" means a real time, continuous HIPAA-compliant computer video and audio link between the hub pharmacy and the remote tele-pharmacy during all hours of the remote tele-pharmacy's operation and in compliance wit…

The board is responsiblefor maintaining, continuing and enhancing the development of the education and professional role of the pharmacist for the protection of the health, welfare and safety of the citizens of New Mexico. In order to maintain, augment or expand the availability …

A. A remote tele-pharmacy shall comply with all standards of 16.19.6.8 NMAC governing the procedure for obtaining a license to operate a pharmacy in New Mexico. (1) The license holder of the hub pharmacy must apply for a license to operate a remote tele-pharmacy. A remote tele-ph…

Regulation and Licensing Department - Board of Pharmacy.

A. Any person who exercises reasonable care in donating, accepting or redistributing prescription drugs pursuant to this section shall be immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death or loss. B. The immunity…

A. Practitioners and licensed clinics must submit the required application form provided by the board to obtain eligibility for participation. B. The board may remove at any time practitioners or any licensed clinics from participating in the reuse of prescription drug donation s…

Participating practitioners and licensed clinics may dispose of unused donated prescription drugs, that were collected but not redistributed, in accordance with state and federal requirements for disposal of prescription drugs.

Participating practitioners shall monitor FDA recalls, market withdrawals, and safety alerts and will communicate with recipients if medications they received may be impacted by this FDA action.

This section applies to licensed clinics and participating practitioners located within the state of New Mexico who provide for the donation and redistribution of previously dispensed prescription drugs that have not been used.

Section 26-1-3.2 of the New Mexico Drug, Device and Cosmetic Act requires the board of pharmacy to promulgate rules establishing standards and procedures necessary for the safe redistribution of previously dispensed prescription drugs.

Permanent.

November 27, 2011, unless a different date is cited at the end of a section.

The objective of Part 34 of Chapter 19 is to ensure the safe donation and redistribution of unused prescription drugs by licensed clinics and participating practitioners by establishing standards and procedures including but not limited to accepting, storing, packaging, labeling,…

A. "Board" means the New Mexico board of pharmacy. B. "Clinic" means a facility licensed pursuant to Section 61-22-14 NMSA 1978 in which one or more licensed practitioners diagnose and treat patients and in which drugs are stored, dispensed or administered for the diagnosis and t…

All clinics and participating practitioners shall follow the procedures for accepting and redistributing certain donated prescription drugs, including refrigerated drugs, consistent with public health and safety standards. A. Before accepting donated prescription drugs the clinic…

All clinics and participating practitioners shall provide separate records or forms documenting the receipt and redistribution of all unused prescription drugs and maintain the records for three years. A. A form to be signed by the donor serving as receipt of the drug verifying t…

Regulation and Licensing Department - Board of Pharmacy.

A. All facilities used for drug warehouses shall be secure from unauthorized entry and; (1) access from outside the premises shall be kept to a minimum and well-controlled; (2) the outside perimeter of the premises shall be well-lighted; (3) entry into areas where prescription dr…

A. Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage…