54,212 sections across 3,422 New Mexico regulatory chapters.
R.16.19.11-16.19.11.2 SCOPE
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All nursing homes and custodial care facilities; all health care professionals who provide pharmaceutical products or services, including the ordering and administration of drugs, to patients in nursing homes and custodial care facilities. Hospital based Skilled Nursing Facilitie…
R.16.19.11-16.19.11.3 STATUTORY AUTHORITY
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Section 61-11-6.A(6) NMSA 1978 authorizes the Board of Pharmacy to license nursing home drug facilities and all places where dangerous drugs are dispensed or administered and to provide for the inspection of their facilities and activities. Section 61-11-14.B(9) NMSA 1978 directs…
R.16.19.11-16.19.11.4 DURATION
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Permanent.
R.16.19.11-16.19.11.5 EFFECTIVE DATE
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December 15, 2002, unless a later date is cited at the end of a Section.
R.16.19.11-16.19.11.6 OBJECTIVE
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The objective of Part 11 of Chapter 19 is to establish standards for the ordering, administration, maintenance and disposal of drugs for patients in nursing homes, skilled nursing facilities, and long-term care and custodial care facilities and to ensure that the facilities' phar…
R.16.19.11-16.19.11.7 DEFINITIONS
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A. Licensed Facility - Any facility, skilled nursing facility, intermediate care or any other upper level of care facility as defined by Health and Human Services Department that is required to maintain custody of patients drugs in a drug room, and such drugs are administered by …
R.16.19.11-16.19.11.8 MINIMUM STANDARDS
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A. MINIMUM STANDARDS FOR THE DISTRIBUTION, STORAGE, HANDLING AND RECORD KEEPING OF DRUGS: (1)The pharmaceutical service shall be organized and maintained primarily for the beneft and safety of the patient. (2) All medications administered to patients shall be by direct order of a…
R.16.19.12-16.19.12.1 ISSUING AGENCY
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Board of Pharmacy
R.16.19.12-16.19.12.10 CERTIFICATE OF REGISTRATION OR REPLACEMENT
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Any replacement of a certificate shall be accompanied by a notarized statement of the reason or cause of the loss of the original, or by the original certificate to be replaced in case of damage or name change. All replacement certificates will be given the same number as the ori…
R.16.19.12-16.19.12.11 CERTIFICATION OF GRADES AND INTERNSHIP HOURS
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A. Certification of Grades $10.00 B. Certification of Internship Hours $10.00
R.16.19.12-16.19.12.12 LICENSE/REGISTRATION RENEWAL
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A. Pharmacist license renewal for active $200.00 bi-ennially B. Pharmacist license renewal for in-active $70.00 bi-ennially C. Intern renewal $25.00 per year D. Duplicate license for interns and pharmacists $10.00 E. Controlled substance registration $180.00 tri-ennially A locum …
R.16.19.12-16.19.12.13 LICENSE FEES
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A. Drug manufacturer $1000.00 bi-ennially B. Wholesale drug distributor $1000.00 bi-ennially C. Drug manufacturer/re-packager $1000.00 bi-ennially D. Re-packager $1000.00 bi-ennially E. Retail pharmacy $300.00 bi-ennially F. Hospital pharmacy $300.00 bi-ennially G. Nonresident ph…
R.16.19.12-16.19.12.14 DRUG ROOM PERMIT
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A. Drug room permit in adult shelter care or custodial care facility: (1) 10 or fewer beds: $100.00 bi-ennially (2) 11 or more beds: $200.00 bi-ennially B. Drug room permit in an intermediate nursing home facility $200.00 bi-ennially C. Drug room permit in a skilled nursing home …
R.16.19.12-16.19.12.15 CLINIC LICENSE FEES
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A. Class A, B, C, or E Clinic $300.00 bi-ennially B. Class D clinic $50.00 bi-ennially C. Animal control clinic $100.00 bi-ennially
R.16.19.12-16.19.12.16 HOME CARE SERVICES DRUG PERMIT FEE
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$75.00 per year
R.16.19.12-16.19.12.17 LIMITED VETERINARY DRUG RETAIL OR WHOLESALE LICENSE
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Limited veterinary drug retail or wholesale license shall be: $150.00 per year
R.16.19.12-16.19.12.18 INSPECTION FEE
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A. Initial inspection or reinspection $150.00 B. Pre-licensing inspection for Class D clinic $30.00
R.16.19.12-16.19.12.19 DRUG PRECURSOR LICENSE
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Drug precursor manufacturer or distributor license: $500.00 bi-ennially
R.16.19.12-16.19.12.2 SCOPE
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All applicants for licensure, registration or certification by the Board of Pharmacy.
R.16.19.12-16.19.12.20 REINSTATEMENT FEES
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Any person whose board registration or license has expired and who seeks reinstatement of the certificate of license must pay the following reinstatement fee in addition to all delinquent renewal fees: A. Pharmacists $25.00 B. All other licenses issued by the board of pharmacy un…
R.16.19.12-16.19.12.21 EMS LICENSURE FEES
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Annual license fees shall be paid to the Board according to the following schedule: A. The home office or headquarters shall pay $50.00; B. Every additional location shall pay $25.00.
R.16.19.12-16.19.12.3 STATUTORY AUTHORITY
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Section 30 -31-11 NMSA 1978 authorizes the board of pharmacy ("board") to charge reasonable fees relating to the registration and control of the manufacture, distribution and dispensing of controlled substances. Section 30-31B-6 NMSA 1978 authorizes the board to charge reasonable…
R.16.19.12-16.19.12.4 DURATION
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Permanent.
R.16.19.12-16.19.12.5 EFFECTIVE DATE
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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.
R.16.19.12-16.19.12.6 OBJECTIVE
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The objective of Part 12 of Chapter 19 is to ensure uniform imposition and collection of fees that conform to statutory requirements for individuals and entities that provide pharmaceutical products and services.
R.16.19.12-16.19.12.7 DEFINITIONS
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[RESERVED]
R.16.19.12-16.19.12.8 FEES
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All fees shall be paid in advance of the issuance of any license, permit, certificate or replacement of a certificate and shall not be refundable.
R.16.19.12-16.19.12.9 REGISTRATION FEES
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A. Registration by examination $200.00 B. Registration by reciprocity $200.00 C. Registration as an intern $25.00 D. Registration as a pharmacy technician $25.00 E. Waiver of registration fees: The board of pharmacy waives the registration fee set forth in regulation 16.19.12.9 f…
R.16.19.13-16.19.13.1 ISSUING AGENCY
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Regulation and Licensing Department Board of Pharmacy, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505) 841-9102.
R.16.19.13-16.19.13.2 SCOPE
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All business entities that possess, administer, dispense and/or distribute prescription drugs and/or devices for the purpose of providing pharmaceutical products and services.
R.16.19.13-16.19.13.3 STATUTORY AUTHORITY
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Section 61-11-6.B.(1) NMSA 1978 authorizes the Board to delegate its authority to the Executive Director to issue temporary licenses as provided in Section 61-11-14.H. NMSA 1978.
R.16.19.13-16.19.13.4 DURATION
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Permanent.
R.16.19.13-16.19.13.5 EFFECTIVE DATE
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December 15, 2002, unless a later date is cited at the end of a Section.
R.16.19.13-16.19.13.6 OBJECTIVE
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To expedite the licensure of business entities providing pharmaceutical products and services. Temporary licenses shall only be issued after the applicant has completed a deficiency free facility inspection.
R.16.19.13-16.19.13.7 DEFINITIONS
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All terms defined in the Pharmacy Act or elsewhere in the Board regulations shall have the same meaning in this regulation unless otherwise defined below: A. Deficiency Free Inspection means compliance with all Board pre-licensing inspection requirements. B. [Reserved]
R.16.19.13-16.19.13.8 PROCEDURE FOR TEMPORARY LICENSURE OF BUSINESS ENTITIES THAT POSSESS, ADMINISTER, DISPENSE AND/OR DISTRIBUTE PRESCRIPTION DRUGS AND/OR DEVICES
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A. Prior to issuance of a permanent license, an applicant may apply once, for each location, for a temporary license. The applicant shall submit required application and fee to the Board office. B. After preliminary approval of the application, the applicant shall submit a "Reque…
R.16.19.14-16.19.14.1 ISSUING AGENCY
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Board of Pharmacy.
R.16.19.14-16.19.14.10 MISBRANDING
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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 …
R.16.19.14-16.19.14.11 RESTRICTED DEVICE (PRESCRIPTION STATUS)
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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 labe…
R.16.19.14-16.19.14.12 CUSTOM DEVICES
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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 per…
R.16.19.14-16.19.14.13 PROCEDURE FOR LICENSURE OF BUSINESS FOR MEDICAL GAS REPACKAGER OR SELLER AND FOR TRANSFER OF OWNERSHIP OF LICENSED BUSINESSES
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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 pur…
R.16.19.14-16.19.14.14 LICENSE REQUIREMENTS MEDICAL GAS REPACKAGER OR SELLER
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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 …
R.16.19.14-16.19.14.15 MINIMUM QUALIFICATIONS MEDICAL GAS REPACKAGER OR SELLER
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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 …
R.16.19.14-16.19.14.16 MINIMUM REQUIREMENTS
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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…
R.16.19.14-16.19.14.17 CHANGE IN LOCATION OF A MEDICAL GAS REPACKAGER OR SELLER
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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 th…
R.16.19.14-16.19.14.18 TRANSFER OF OWNERSHIP
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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…
R.16.19.14-16.19.14.19 PRESCRIPTION REQUIREMENT
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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 …
R.16.19.14-16.19.14.2 SCOPE
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All individuals and entities subject to the New Mexico Drug, Device and Cosmetic Act, Chapter 26, Article I NMSA 1978.
R.16.19.14-16.19.14.20 REPORT OF ROBBERY, FIRE AND FLOOD
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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…
R.16.19.14-16.19.14.3 STATUTORY AUTHORITY
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Paragraph 7 of Subsection A of Section 61-11-6 NMSA 1978 authorizes the Board to enforce the provisions of all state laws pertaining to the practice of pharmacy and the manufacture, production, sale or distribution of drugs, cosmetics or poisons, including the New Mexico Drug, De…