reglab/statecodes huggingface dataset:
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.10 - MISBRANDING

Current through Register Vol. 35, No. 13, July 16, 2024
A device may be deemed to be misbranded if:
A. Manufactured in a nonregistered
				establishment pursuant to federal requirements.
B. If advertising and description literature
				fails to meet minimum requirements for disclosure of product
				information.
C. Devices subject to
				performance standards set by FDA, whose labeling fails to meet those prescribed
				in the standard.
D. Devices that
				fail or whose manufacturer refuses to comply with requirements relating to
				notification and other remedies and requirements or fails to maintain adequate
				records and necessary reports as required under the federal act Section
				518-519.
E. If its label does not
				bear adequate directions for use and adequate warning against unsafe
				use.
F. If the labeling is false or
				misleading.
G. If it is a
				restricted device and fails to bear required labeling.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.11 - RESTRICTED DEVICE (PRESCRIPTION STATUS)

Current through Register Vol. 35, No. 13, July 16, 2024
A. FDA requirements may restrict the sale,
				distribution, or use of a device if there cannot be reasonable assurance of its
				safety and effectiveness.
B.
				Prescription status devices are determined on the basis of its intended use and
				whether or not the device can be adequately labeled as usable by the layman
				(i.e., pacemaker, hearing aids, hear valves, etc.).
C. Labeling must contain certain information
				such as name of device, statement of intended use, relevant warnings,
				precaution, side effects and contraindications.
D. Labeling of a restricted device, other
				than surgical instruments, shall bear:
(1)
				"CAUTION: Federal law restricts this device to sale by or on the order of a
				______:, physician, dentist, veterinarian, or with the descriptive designation
				of any other practitioner licensed by the laws of this State to prescribe or
				use the device in his practice.
(2)
				The method of its application or use.
(3) The label meets all other requirements
				under CFR Title 21, Section 801.109 (c) and (d) and (e).
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.12 - CUSTOM DEVICES

Current through Register Vol. 35, No. 13, July 16, 2024
A. A custom
				device is one which is sometimes ordered from manufacturers by practitioners to
				conform to their own special needs or to those of their patients (i.e.
				prosthetic devices, dental devices and specially designed orthopedic
				footwear).
B. Custom devices are
				exempt from performance standards or pre-market approval requirements; however,
				they are subject to FDA requirements for investigational use, banning,
				restriction of distribution, adulteration and misbranding.
C. The exemption applied only to devices
				which are not generally available in finished form for dispensing, or on
				prescription, or for commercial distribution or generally available to other
				practitioners.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.13 - PROCEDURE FOR LICENSURE OF BUSINESS FOR MEDICAL GAS REPACKAGER OR SELLER AND FOR TRANSFER OF OWNERSHIP OF LICENSED BUSINESSES

Current through Register Vol. 35, No. 13, July 16, 2024
A. An applicant shall submit required
				application and fee to the board. Applications for a license or license renewal
				under this section shall be made on a form furnished by the board. The board
				may require such information as it deems is reasonably necessary to carry out
				the purposes of this part.
B. After
				preliminary approval of a new application for licensure, an applicant that is
				located in New Mexico shall submit a request for inspection and the inspection
				fee, where applicable, in advance of fourteen days of the requested date for
				inspection. All subsequent requests for inspection shall be submitted in
				advance of fourteen days of the requested date for inspection.
C. The license provided for herein shall
				terminate upon the sale or transfer of ownership. Operation of a business
				subsequent to the date of such transfer or sale without a new application and
				approval by the board shall constitute a violation of the law under Subsection
				I of Section
				61-11-14 NMSA 1978, and is subject
				to the penalties contained in the Pharmacy Act.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.14 - LICENSE REQUIREMENTS MEDICAL GAS REPACKAGER OR SELLER

Current through Register Vol. 35, No. 13, July 16, 2024
A. Every medical gas repackager or seller,
				wherever located, shall be licensed by the board in accordance with the laws
				and regulations of this state before engaging in repackaging, distribution or
				selling of medical gases in this state.
B. Repackagers and sellers cannot operate
				from a place of residence. No primary business location will be operated out of
				a storage unit. Use of a storage unit shall be consistent with accrediting body
				approval and allowance.
C. Where
				operations are conducted at more than one location, each such location shall be
				licensed by the board.
D. A
				manufacturer or wholesale drug distributor licensed by the board may distribute
				medical gas without the requirement of a separate medical gas license. Said
				licensees shall distribute only to an entity licensed to receive medical gas. A
				pharmacy, dentist, or licensed prescriber's license verifies their authority to
				receive prescription only medical gases.
E. A pharmacy licensed by the board may
				provide medical gas pursuant to a drug order, or to nearby emergency medical
				services, i.e., ambulance companies and firefighting organizations in the same
				state or same marketing or service area, or nearby licensed practitioners
				allowed to prescribe medical gases for use in the treatment of acutely ill or
				injured persons; to nearby or contracted nursing homes or home care services;
				or to another pharmacy to alleviate a temporary shortage without the
				requirement of a separate medical gas license.
F. The Board may prohibit a person or entity
				from receiving or maintaining licensure if the person or entity:
(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 of Section 1365
				of title 18, United States Code, relating to product tampering; or
(2) has been found by the board to have
				violated the requirements of this part, or state requirements for
				licensure.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.15 - MINIMUM QUALIFICATIONS MEDICAL GAS REPACKAGER OR SELLER

Current through Register Vol. 35, No. 13, July 16, 2024
A. Compliance with
				federal, state, and local law. Repackagers and sellers shall operate in
				compliance with all applicable federal, state, and local laws and
				regulations.
B. Every person or
				entity subject to this part shall meet the federal requirements to handle
				medical gas, the Prescription Drug Marketing Act at
				21 U.S.C., Sec.
				331 et seq., and any other applicable
				federal, state, or local laws and regulations. Said applicants and licensees
				shall be registered with the FDA, if required.
C. Every person or entity subject to this
				part must conform to the Compressed Medical Gases Guidelines published by the
				FDA.
D. Personnel. As a condition
				of receiving and retaining a license under this part, the licensee or applicant
				shall require each person employed in any medical gas related activity to have
				education, training, and experience, or any combination thereof, sufficient for
				that person to perform the assigned functions in such a manner as to provide
				assurance that the medical gas quality, safety and security will at all times
				be maintained by law.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.16 - MINIMUM REQUIREMENTS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Written
				policies and procedures. Repackagers and sellers shall establish, maintain, and
				adhere to written policies and procedures, which shall be followed for the
				proper receipt, security, storage, handling, repackaging, labeling, inventory,
				distribution, quarantine, return or disposition of medical gases, for
				identifying, recording and reporting losses or thefts, for correcting all
				errors and inaccuracies in inventories, for maintenance of required drug
				records in proper form, and handling recalls.
B. The facility shall be of suitable size and
				construction, with adequate lighting, environmental control, quarantine,
				cleanliness and pest control.
C.
				The facility shall be secure from unauthorized entry.
D. Recordkeeping. Medical gas repackagers and
				sellers shall establish and maintain inventories and records of all
				transactions regarding the receipt and distribution or other disposition of
				medical gas.
E. Inventories and
				records shall be made available for inspection and copying by Board inspectors
				for a period of at least three (3) years.
F. All repackagers or sellers in New Mexico
				must publicly display or have readily available all required licenses and the
				most recent inspection report administered by the board.
G. Medical gas repackagers shall distribute
				only to an entity licensed to receive medical gas. A pharmacy, dentist, or
				licensed prescriber's license verifies their authority to receive prescription
				only medical gases.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.17 - CHANGE IN LOCATION OF A MEDICAL GAS REPACKAGER OR SELLER

Current through Register Vol. 35, No. 13, July 16, 2024
Before any person or entity subject to this part located in
				  New Mexico changes the location of the facility, a new application shall be
				  submitted to the board, setting forth such changes. Upon approval and
				  completion of the change, a request for inspection will be submitted to the
				  board. There will be no charge for the new application, but the inspection will
				  carry the same fee as applies for a new facility inspection.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.18 - TRANSFER OF OWNERSHIP

Current through Register Vol. 35, No. 13, July 16, 2024
A transfer of ownership occurs upon.
A. The sale of the facility to another
				individual or individuals by the present owner.
B. The addition or deletion of one or more
				partners in a partnership.
C. The
				death of a singular or sole owner.
D. The change of ownership of thirty percent
				or more of the voting stock of a corporation since the issuance of the license
				or last renewal application.
E. A
				new license application will be required to be filed in each of the above
				circumstances. As stated in the Pharmacy Act, Subsection I of Section
				61-11-14 NMSA 1978, licenses are
				not transferable, and shall expire on December 31 of every other year unless
				renewed.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.19 - PRESCRIPTION REQUIREMENT

Current through Register Vol. 35, No. 13, July 16, 2024
A.
				Prescription requirement, in general: A designated medical gas shall be subject
				to the requirements of 21
				U.S.C. section 353(b)(1)
				unless the Secretary of the FDA exercises the authority provided in section
				353(b)(3) to remove such medical gas from the requirements of section
				353(b)(1), the gas is approved for use without a prescription pursuant to an
				application under 21 U.S.C.
				section 355 or
				360b, or the use in question is
				authorized pursuant to another provision of this part relating to use of
				medical products in emergencies.
B.
				Oxygen, no prescription required for certain uses: oxygen may be provided
				without a prescription for the following uses:
(1) for use in the event of depressurization
				or other environmental oxygen deficiency; and
(2) for oxygen deficiency or for use in
				emergency resuscitation, when administered by properly trained
				personnel.
(3) Labeling - For
				oxygen provided pursuant to this Subsection B., the requirements of section
				353(b)(4) of 21 U.S.C. shall be deemed to have been met if its labeling bears a
				warning that the oxygen can be used for emergency use only and for all other
				medical applications a prescription is required.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 14 - DEVICES; MEDICAL GAS REPACKAGERS AND SELLERS › Section 16.19.14.20 - REPORT OF ROBBERY, FIRE AND FLOOD

Current through Register Vol. 35, No. 13, July 16, 2024
When a medical gas repackager or seller located in New Mexico
				  is involved in a robbery, fire, flood or any unusual event in which medical
				  gases might be missing or damaged, the owner shall immediately file with the
				  Board, a signed statement of the circumstances of such occurrence and evidence
				  that local authorities were notified, if applicable.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.1 - ISSUING AGENCY

Current through Register Vol. 35, No. 13, July 16, 2024
Regulation and Licensing Department, Board of Pharmacy,
				  Albuquerque NM.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
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 dispense lower cost versions of
				  multiple-source drugs that meet a final determination of the federal government
				  that is published in the federal register. Section
				  26-3-2 of the
				  DPSA states that the purpose of the DPSA is to assure that all New Mexico
				  citizens continue to receive high quality drugs at a reasonable cost.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
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 Act
				  by providing a uniform standard for drug product selection of animal drugs.
				  Section 26-3-3(A) NMSA 1978 permits a pharmacist to select a lower cost
				  multiple source drug that meets a final determination in the federal register
				  when a more costly version of the drug is prescribed. Animal drugs approved by
				  FDA are subject to final determinations in the federal register and therefore
				  qualify for drug product selection as described in this
				  regulation.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.8 - MANUFACTURER'S LABEL

Current through Register Vol. 35, No. 13, July 16, 2024
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 employee or employees designated by the licensee
				only on the written order or prescription of a veterinarian licensed in this
				state; or
B. if the order or
				prescription is other than a written order, the designated individual receiving
				the oral order or prescription shall immediately reduce such order to writing
				and the person receiving the order shall indicate the following information on
				the written record.
(1) name and address of
				the licensed veterinarian;
(2) name
				and strength of drug prescribed;
(3) quantity of drug ordered by the
				veterinarian;
(4) directions for
				use and cautionary statements, if given, by the veterinarian
				prescriber;
(5) date of
				order;
(6) name of owner and/or
				consignee of animal or animals;
(7)
				name of individual taking order from veterinarian prescriber.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.9 - DANGEROUS VETERINARY DRUGS AND ANIMAL DRUG PRODUCT SELECTION

Current through Register Vol. 35, No. 13, July 16, 2024
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 any lower cost animal drug that is:
(1) therapeutically equivalent to the
				prescribed animal drug;
(2)
				bioequivalent to the prescribed animal drug; and
(3) listed in FDA's list of approved animal
				drug products (the "green book").
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.10 - DRUGS, LABEL CONTENT

Current through Register Vol. 35, No. 13, July 16, 2024
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 original order or
				prescription;
(4) name and address
				of licensed veterinarian prescriber;
(5) name of owner and/or consignee of the
				animal or animals;
(6) directions
				for use and cautionary statements, if any, contained in the order or
				prescription.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.11 - PACKAGE INSERT

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.12 - LABELS, CASE LOT DISTRIBUTION

Current through Register Vol. 35, No. 13, July 16, 2024
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 on each case or
				carton.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.13 - DANGEROUS VETERINARY USE DRUGS, MISBRANDED

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.14 - AUTHORIZATION

Current through Register Vol. 35, No. 13, July 16, 2024
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 date of such authorization and the
				signature of the individual receiving such authorization from the
				prescriber.
B. A prescription or
				order shall be valid for no more than 12 months from the date of
				issue.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.15 - NUMBERED PRESCRIPTIONS

Current through Register Vol. 35, No. 13, July 16, 2024
Prescriptions or orders must be consecutively numbered and
				  filed by the retail veterinary drug distributor. Such files shall be kept for
				  three years.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.16 - INVOICES AND RECORDS FOR DANGEROUS VETERINARY DRUGS

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.17 - STOCK OR INVENTORY OF DANGEROUS VETERINARY DRUGS

Current through Register Vol. 35, No. 13, July 16, 2024
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, storage and
				control of dangerous drugs shall be such as to prevent having outdated or
				deteriorated drugs in stock. Expiration dated drugs shall be checked
				periodically for outdated products. Outdated products shall be returned to the
				supplier or destroyed.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.18 - DISPOSAL OF INVENTORY - PERMISSION REQUIRED

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.19 - REPORT OF ROBBERY, FIRE AND FLOOD

Current through Register Vol. 35, No. 13, July 16, 2024
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 evidence that
				  local authorities were notified, if applicable.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 15 - DANGEROUS VETERINARY DRUGS - RETAIL DISTRIBUTION › Section 16.19.15.20 - CONSULTANT PHARMACIST

Current through Register Vol. 35, No. 13, July 16, 2024
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. Consultant pharmacists to retail
				distributors of veterinary prescription products that do not dispense
				controlled substances are required to visit the licensed facility
				quarterly.
B. The consultant
				pharmacist shall maintain a log or record of all visits and activities at the
				retail distributor of veterinary prescription products. That record shall
				document at least the following:
(1) the date
				of the annual review of the Policy and Procedure Manual required by 16.19.4.11
				NMAC;
(2) prescriptions are in a
				consecutively numbered file;
(3)
				all procurement, distribution by precription wholesalers, and disposition
				records are maintained for at least 3 years;
(4) all inventory of dangerous drugs is
				stored in an area not accessible to unauthorized persons;
(5) all dangerous drugs are stored according
				to USP/NF requirements with adequate ventilation, lighting, temperature
				controls and refrigeration;
(6) the
				facility is in compliance with all State and Fedral laws and regulations for
				the procurement, storage and dispensing of dangerous drugs; and
(7) orientation and training of all facility
				employees, who have access to the dangerous drugs, to the legal requirements of
				dangerous drugs and to the Policy and Procedure Manual of the
				facility.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 16 - SAMPLE DRUG DISTRIBUTION › Section 16.19.16.1 - ISSUING AGENCY

Current through Register Vol. 35, No. 13, July 16, 2024
Regulation and Licensing Department - Board of Pharmacy, 1650
				  University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505)
				  841-9102.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 16 - SAMPLE DRUG DISTRIBUTION › Section 16.19.16.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
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 state
				  pertaining to the distribution of drugs.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 16 - SAMPLE DRUG DISTRIBUTION › Section 16.19.16.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 16 - SAMPLE DRUG DISTRIBUTION › Section 16.19.16.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 16 - SAMPLE DRUG DISTRIBUTION › Section 16.19.16.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. Sample - means a
				drug which is not intended to be sold and is intended to promote the sale of
				the drug.
B. [Reserved]
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 16 - SAMPLE DRUG DISTRIBUTION › Section 16.19.16.8 - DISTRIBUTION OF PHARMACEUTICAL SAMPLES

Current through Register Vol. 35, No. 13, July 16, 2024
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) Pharmaceutical products sold for export
				only;
(3) Pharmaceuticals purchased
				by hospitals, and/or clinics, including agencies of state and local governments
				for the exclusive use of those institutions and not intended for
				resale;
(4) Pharmaceutical products
				donated or supplied at reduced prices to charitable institutions in the United
				States or abroad for their own institutional use;
(5) Complementary pharmaceutical product
				trade packages.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH › Section 16.19.17.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
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 the New
				  Mexico department of health.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH › Section 16.19.17.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
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)
				  NMSA 1978 authorizes the board to provide for the licensing of all places where
				  dangerous drugs are stored, distributed, dispensed or administered and provide
				  for the inspection of the facilities and activities. Section
				  26-1-16.A(2)
				  NMSA 1978 authorizes the board to license any person to sell, dispose of or
				  possess any dangerous drug. Appropriate records of receipt and disposition must
				  be kept.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH › Section 16.19.17.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
February 15, 1996, unless a later date is cited at the end of
				  a section.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH › Section 16.19.17.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
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 conducting research,
				  including demonstrations or special projects, after receiving approval from the
				  board.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH › Section 16.19.17.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
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" in
				accordance with Section
				26-1-18
				NMSA 1978 of the Drug, Device and Cosmetic Act, Section
				26-1-18
				NMSA 1978 and the Uniform Licensing Act (Sections
				61-1-1 to
				61-1-31
				NMSA 1978). The board of pharmacy shall by regulation declare a substance a
				"dangerous drug" when necessary and notification shall be sent to all
				registered pharmacies in the state within 60 days of the adoption of the
				regulation. Ephedrine, USP, as ephedrine hydrochloride or ephedrine sulfate or
				as any other salt form. Any compound, mixture, or preparation containing
				one-half percent or less of ephedrine or of any salt form of ephedrine is
				exempt from the above. These products are exempt because they are approved for
				sale over the counter (OTC) without a prescription under federal law, are
				labeled and marketed in a manner consistent with the pertinent OTC tentative
				final or final monograph, are manufactured and distributed for legitimate
				medical use in a manner that reduces or eliminates the likelihood for abuse,
				and are not marketed, advertised or labeled for an indication of stimulation,
				mental alertness, energy, weight loss, appetite control, or muscle enhancement.
				These approved OTC products shall be reported as required of a pseudoephedrine
				containing product as defined in Subsection B of
				16.19.20.53
				NMAC.
(2) A dangerous drug shall be
				dispensed only upon the prescription of a practitioner licensed by law to
				administer or prescribe such drug.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH › Section 16.19.17.8 - RESEARCH LICENSING REQUIREMENTS

Current through Register Vol. 35, No. 13, July 16, 2024
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
				fill out a license for dangerous drug research application prior to purchasing
				any dangerous drug. The applicant must provide information pertinent to the
				research including:
(1) name, address, and
				date of birth of persons who will be involved in handling of dangerous drugs,
				and if they have been convicted of a felony:
(2) drug protocol:
(a) formulary of dangerous drugs for
				research;
(b) how will the
				dangerous drug be utilized;
(c) how
				much of the dangerous drug will be used for each administered dose or
				experiment;
(d) how much drug will
				be purchased annually.
(3) policy and procedure manual including:
(a) drug security: storage area, list of
				individuals with access to dangerous drugs;
(b) drug procurement: invoices, receipts, and
				drug sources;
(c) drug usage:
				records or logs for accountability;
(d) drug waste/destruction: memorandum report
				describing accountability;
(e) drug
				storage area;
(f) research
				protocol: proprietary or trade secrets are confidential and not subject to
				public disclosure;
(4)
				qualifications of the applicant to conduct such research with dangerous drugs
				which may include:
(a) degrees;
(b) higher education;
(c) specialized training.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.2 - SCOPE

Current through Register Vol. 35, No. 13, July 16, 2024
All individuals and entities that provide radiopharmaceutical
				  products or services or engage in the practice of nuclear pharmacy, including
				  owners of nuclear pharmacies.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
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.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
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.
"Nuclear Pharmacy"
means a
				pharmacy which provides radiopharmaceutical services, and shall be licensed by
				the Board as a wholesaler or retail pharmacy.
C.
"Qualified Nuclear
				Pharmacist"
means a pharmacist currently licensed by the Board who meets
				either of the following criteria:
(1) Must be
				currently certified as a Nuclear Pharmacist by the Board of Pharmaceutical
				Specialties; or
(2) Must have
				successfully completed the requirements of Subparagraphs (a) and (b) of this
				Paragraph.
(a) Must have attained a minimum
				of 500 contact hours of experiential training in nuclear pharmacy under the
				supervision of a qualified nuclear pharmacist in, but not limited to, the
				following areas:
(i) procurement of
				radioactive materials;
(ii)
				compounding of radiopharmaceuticals;
(iii) maintenance of a quality assurance
				program;
(iv) dispensing of
				radiopharmaceuticals;
(v)
				distribution of radiopharmaceuticals;
(vi) implementation of basic health and
				safety practices and procedures; and
(vii) provision of information and
				consultation related to the practice of nuclear pharmacy and the use of
				radiopharmaceuticals.
(b) 200 contact hours of didactic instruction
				in nuclear pharmacy and the safe handling and use of radioactive materials,
				from a nationally-accredited college of pharmacy or other training program
				sponsored by an ACPE-accredited provider of continuing pharmaceutical
				education, in the following five areas:
(i)
				radiation physics and instrumentation;
(ii) radiation protection;
(iii) mathematics pertaining to the use and
				measurement of radioactivity;
(iv)
				radiation biology; and
(v)
				radiopharmaceutical chemistry.
(3) Any pharmacist who has been legally
				listed on a radioactive material license for a nuclear pharmacy in the State of
				New Mexico for at least six months prior to the 1994 effective date of these
				regulations, is exempt from Paragraphs (1) and (2) of Subsection C of
				16.19.18.7 NMAC.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.8 - LICENSING REQUIREMENTS FOR A NUCLEAR PHARMACY

Current through Register Vol. 35, No. 13, July 16, 2024
A. The licensing provisions contained in this
				section are in addition to, and not a substitute for, general licensing
				requirements for all pharmacies in New Mexico.
B. Any pharmacy that will provide
				radiopharmaceutical services must obtain a nuclear pharmacy license from the
				Board.
C. A nuclear pharmacy shall
				employ one or more qualified nuclear pharmacists. The application for a nuclear
				pharmacy license must include documentation that all pharmacists who provide
				radiopharmaceutical services in the nuclear pharmacy meet the criteria
				specified for a qualified nuclear pharmacist.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.9 - REQUIREMENTS FOR OPERATION OF A NUCLEAR PHARMACY

Current through Register Vol. 35, No. 13, July 16, 2024
A. A nuclear pharmacy shall meet the
				requirements of 16.19.6 NMAC of the Board, except as provided for in this
				section.
B. A qualified nuclear
				pharmacist shall be in personal attendance when the nuclear pharmacy is open
				for business.
C. A nuclear pharmacy
				shall meet minimum space requirements established for all pharmacies in the
				state (see
				16.19.6.10
				NMAC, with the exception that the space may be interrupted).
D. The nuclear pharmacy shall maintain
				records of procurement, inventory and disposition of all radioactive drugs and
				other radioactive materials.
E. A
				nuclear pharmacy shall have a current copy (paper or electronic) of city,
				state, and federal regulations governing the safe storage, handling, use,
				dispensing, transport and disposal of radiopharmaceuticals.
F. The following minimum equipment
				requirements, as appropriate for the scope of nuclear pharmacy services
				provided, are in addition to those contained in
				16.19.6.11
				NMAC;
(1) Radionuclide Dose
				Calibrator;
(2)
				Refrigerator;
(3) Single or
				multiple channel scintillation counter with well-type NaI(T1) or Ge(Li)
				detector;
(4) Radiochemical fume
				hood and filter system;
(5) Area
				rate meter;
(6) At least two (2) GM
				survey meters;
(7) Microscope and
				hemacytometer;
(8) Laminar air flow
				hood and/or biologic safety cabinet;
(9) Syringe and vial radiation
				shields;
(10) Lead-shielded drawing
				station;
(11) Decontamination
				supplies;
(12) Other equipment as
				needed for radiation safety to workers and the public; or for performance of
				quality control/quality assurance specified by standards of practice for the
				individual setting and the products involved.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 18 - NUCLEAR PHARMACY › Section 16.19.18.10 - REQUIREMENTS FOR PROVISION OF RADIOPHARMACEUTICAL SERVICES

Current through Register Vol. 35, No. 13, July 16, 2024
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 Commission
				or an equivalent agreement state agency to possess, use and administer such
				drug. A radiopharmaceutical shall be dispensed only upon receipt of a
				prescription from such licensed practitioner. Otherwise, a radiopharmaceutical
				may be transferred to a person who is authorized to possess and use such drug
				for non-clinical applications.
C.
				In addition to other labeling requirements of the Board for nonradioactive
				drugs, the outer container shield of a radiopharmaceutical to be dispensed or
				transferred shall also be labeled with the following information:
(1) the standard radiation symbol;
(2) the words "Caution -- Radioactive
				Materials";
(3) the
				radionuclide;
(4) the chemical
				form;
(5) the amount of
				radioactivity and the calibration date and time;
(6) the expiration date and time;
(7) if a liquid, the volume;
(8) if a solid, the number of dosage units or
				weight;
(9) if a gas, the number of
				ampules or vials;
(10) the name of
				the patient (required only for radiolabeled blood components and all
				radiopharmaceuticals intended for therapeutic use).
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 19 - HOME CARE SERVICES › Section 16.19.19.1 - ISSUING AGENCY

Current through Register Vol. 35, No. 13, July 16, 2024
Regulation and Licensing Department - Board of Pharmacy, 1650
				  University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505)
				  841-9102.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 19 - HOME CARE SERVICES › Section 16.19.19.3 - STATUTORY AUTHORITY

Current through Register Vol. 35, No. 13, July 16, 2024
Section 61-11-6(A)(6) NMSA 1978 authorizes the Board 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 limited drug permits
				  for home care services.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 19 - HOME CARE SERVICES › Section 16.19.19.5 - EFFECTIVE DATE

Current through Register Vol. 35, No. 13, July 16, 2024
February 15, 1996, unless a different date is cited at the
				  end of each Section or Paragraph. This Part reformatted for inclusion into the
				  New Mexico Administrative Code (NMAC) effective 2-15-96.
New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 19 - PHARMACISTS › Part 19 - HOME CARE SERVICES › Section 16.19.19.6 - OBJECTIVE

Current through Register Vol. 35, No. 13, July 16, 2024
The objective of Part 19 of Chapter 19 is to establish
				  standards for the safe and competent delivery of pharmaceutical products and
				  services to persons who utilize home care services outside the institutional
				  setting.