54,212 sections across 3,422 New Mexico regulatory chapters.
R.16.19.18-16.19.18.8 LICENSING REQUIREMENTS FOR A NUCLEAR PHARMACY
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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 Boar…
R.16.19.18-16.19.18.9 REQUIREMENTS FOR OPERATION OF A NUCLEAR PHARMACY
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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…
R.16.19.19-16.19.19.1 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.16.19.19-16.19.19.2 SCOPE
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All entities that provide home care services.
R.16.19.19-16.19.19.3 STATUTORY AUTHORITY
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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…
R.16.19.19-16.19.19.4 DURATION
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Permanent.
R.16.19.19-16.19.19.5 EFFECTIVE DATE
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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.
R.16.19.19-16.19.19.6 OBJECTIVE
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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.
R.16.19.19-16.19.19.7 DEFINITIONS
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Definitions as used in this regulation, are: A. "Home care services" means any organization licensed by the New Mexico Department of Health and the Board of Pharmacy to provide skilled nursing services and at least one other therapeutic or supportive service to patients/clients i…
R.16.19.19-16.19.19.8 HOME CARE SERVICES
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A. The New Mexico Board of Pharmacy acknowledges the establishment of home care services outside the institutional setting. In order to protect the people who utilize such services, laws, regulations and safeguards pertaining to drugs must be observed. B. The dangerous drugs acqu…
R.16.19.19-16.19.19.9 DRUG STORAGE
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A. There shall be adequate space for the proper storage of drugs provided with proper ventilation, lighting, temperature controls and refrigeration. B. Dangerous drugs must be stored in a special locked space which provides adequate security. C. Purchase, storage and control of d…
R.16.19.2-16.19.2.1 ISSUING AGENCY
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Board of Pharmacy.
R.16.19.2-16.19.2.10 RESERVED
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R.16.19.2-16.19.2.11 COMPLETION OF INTERNSHIP
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No applicant may be admitted to the examination until completion of required internship has been certified by the Board.
R.16.19.2-16.19.2.12 QUALIFICATIONS
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The board shall not recognize as sufficient qualifications for licensure the diploma of any school or college of pharmacy.
R.16.19.2-16.19.2.13 PHOTO REQUIRED
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Each applicant for licensure shall furnish a current photograph, head and shoulders only, approximately 3 x 4 inches.
R.16.19.2-16.19.2.14 REINSTATEMENT EXAMINATIONS
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A. The board may require an applicant for reinstatement of licensure, for any reason, including revocation, to make a passing score on any combination of the NAPLEX and MPJE. B. The criteria for passing these examinations shall be the same as required by this regulation. C. If a …
R.16.19.2-16.19.2.2 SCOPE
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All applicants for licensure as pharmacists by examination or reinstatement of licensure by examination.
R.16.19.2-16.19.2.3 STATUTORY AUTHORITY
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Section 61-11-9 NMSA 1978 establishes qualifications for licensure as a pharmacist by examination. Paragraph (2) of Subsection A of Section 61-11-6 NMSA 1978 requires that the board of pharmacy provide for examinations of applicants for licensure as pharmacists.
R.16.19.2-16.19.2.4 DURATION
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Permanent.
R.16.19.2-16.19.2.5 EFFECTIVE DATE
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February 15, 1996, unless a later date is cited at the end of a section.
R.16.19.2-16.19.2.6 OBJECTIVE
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The objective of Part 2 of Chapter 19 is to identify candidate's qualifications and establish uniform criteria for obtaining licensure as a pharmacist by examination.
R.16.19.2-16.19.2.7 DEFINITIONS
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A. "ACPE" Accreditation Council for Pharmacy Education B. "FPGEE" Foreign Pharmacy Graduate Equivalency Examination C. "MPJE" Multistate Pharmacy Jurisprudence Examination D. "NABP" National Association of Boards of Pharmacy E. "NAPLEX" North American Pharmacist Licensure Examina…
R.16.19.2-16.19.2.8 APPLICATIONS - SUBJECTS
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Applicants for licensure by examination shall pass the standard national examination currently known as the NAPLEX and pass the MPJE. A. EXAMINATIONS: (1) In order to sit for the NAPLEX, the applicant must be a graduate from a college of pharmacy accredited by the ACPE. (2) Candi…
R.16.19.2-16.19.2.9 EXAMINATION REPEATS
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A candidate who fails either the NAPLEX or MPJE may repeat that examination upon submittal of the proper application and fee. A candidate may not take either the NAPLEX or MPJE more than four consecutive times without passing, and the time limit is three years from the first exam…
R.16.19.20-16.19.20.1 ISSUING AGENCY
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Board of Pharmacy.
R.16.19.20-16.19.20.10 REGISTRATION FEE
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A. The registration fee or renewal fee required by the Controlled Substances Act shall be as listed in 16.19.12 NMAC. B. Research applicants registered as a practitioner shall not be required to register as a scientific investigator if he is registered as a practitioner. However,…
R.16.19.20-16.19.20.11 APPLICATION FORMS
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Application forms may be obtained from the board of pharmacy, Albuquerque, New Mexico.
R.16.19.20-16.19.20.12 SCHEDULES
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Applications shall designate the schedule of controlled substances and whether the application is for narcotic or non-narcotic in schedules I through V.
R.16.19.20-16.19.20.13 SEPARATE REGISTRATION OF EACH PRINCIPAL PLACE OF BUSINESS
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Separate registration is required for each principal place of business or professional practice with the address indicated on the application if drugs are dispensed or distributed from the different locations. NOTE: This does not include warehouse storage areas; office used by ag…
R.16.19.20-16.19.20.14 INFORMATION REQUIRED
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A. The board shall register an applicant to manufacture or distribute controlled substances unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the board may consider the following factors…
R.16.19.20-16.19.20.15 FACILITY INSPECTION
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The board of pharmacy may direct the drug inspector to inspect the facilities prior to approval of any application for security provision and other applicable standards as required by the Controlled Substances Act.
R.16.19.20-16.19.20.16 PROCEDURE SUMMARY, RESEARCH
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A scientific investigator or research applicant shall submit a summary of procedures indicating the nature, extent and duration of such research. The summary shall also include the names of individuals engaged in the project (other than those exempt under the Controlled Substance…
R.16.19.20-16.19.20.17 ANALYTICAL LABORATORIES
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A. Analytical laboratory applicants shall submit application on the form provided by the board. All applicable questions on the application shall be filled in and signed by the person in charge of the facility. B. Quantities of controlled substances in possession of analytical la…
R.16.19.20-16.19.20.18 EXEMPTION OF LAW ENFORCEMENT OFFICIALS
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Registration is waived for the following persons: A. Any officer or employee of the state or federal customs agency, the state police, or any enforcement officer of any political subdivision of the state, who is engaged in the enforcement of any federal, state and local law relat…
R.16.19.20-16.19.20.19 MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION
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A. Modification of a registration to authorize additional controlled substances may be made by filing an application in the same number as an application for a new registration. No fee shall be required for such modification. B. Registration shall terminate if and when a registra…
R.16.19.20-16.19.20.2 SCOPE
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All persons or entities that manufacture, distribute, dispense, administer, prescribe, deliver, analyze, or conduct research using controlled substances.
R.16.19.20-16.19.20.20 INVENTORY RECORDS
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A. All registrants are required to keep inventory and procurement records. B. All registrants shall comply with the following inventory requirements: schedule I, II, III, IV and V initial, annual, newly controlled substances, change in pharmacist in charge, and transfer of pharma…
R.16.19.20-16.19.20.21 INVENTORY RECORDS OF MANUFACTURERS AND REPACKAGERS
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Manufacturers and repackagers inventory records shall contain the following information: A. Finished form: (1) name of substance; (2) each finished form of the substance (10 milligram tablet, etc.) (3) the number of units or volume of each finished form in each commercial contain…
R.16.19.20-16.19.20.22 DISTRIBUTION INVENTORY RECORDS
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Distributor inventory records shall contain the same information required of manufacturers.
R.16.19.20-16.19.20.23 INVENTORY REQUIREMENTS - RESEARCH
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A. Research registrant shall include in his inventory the name of the substance, each finished form of the substance, the number of units or volume of each finished form in each commercial container (100 tablet bottle, etc.) and the number of commercial containers of each such fi…
R.16.19.20-16.19.20.24 ANALYTICAL LABORATORIES
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Analytical laboratories shall include in the inventory record the same information required of manufacturer's.
R.16.19.20-16.19.20.25 CONTROLLED SUBSTANCES INVENTORIES AND RECORDS
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A. Pharmacies, hospitals, clinics and practitioners who dispense controlled substances shall maintain inventories and records of controlled substances listed in schedules II and II-N separately from all of the other prescription records. B. "Readily retrievable" means records kep…
R.16.19.20-16.19.20.26 PROCUREMENT RECORDS
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"Order forms"refer to DEA form 222 or its electronic equivalent required for distribution or procurement of a schedule I or II controlled substance under the federal act.
R.16.19.20-16.19.20.27 ORDER FORMS AS RECORDS
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Order forms for schedule I and II controlled substances shall be deemed proper record of receipt, if the purchaser records on copy 3 of the order form the number of commercial or bulk containers furnished of each item and the date on which such containers are received by the purc…
R.16.19.20-16.19.20.28 INVENTORY RECORDS
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All schedule I and II narcotic substance inventory records and procurement records will be kept separate from other records of the registrant.
R.16.19.20-16.19.20.29 PROCUREMENT RECORDS
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Procurement records, other than the inventory, may be kept at a central location, rather than at the registered location, if prior approval has been obtained under the federal regulations; provided such records are delivered, upon request of the board, to the registered location …
R.16.19.20-16.19.20.3 STATUTORY AUTHORITY
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Section 30-31-11 of the Controlled Substances Act, 30-31-1 through 30-31-42 NMSA 1978, authorizes the board of pharmacy to promulgate regulations and charge reasonable fees for the registration and control of the manufacture, distribution and dispensing of controlled substances. …
R.16.19.20-16.19.20.30 DISPOSITION RECORDS
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Practitioner's disposition records shall include date of dispensing, name of patient, name and strength of substance and amount dispensed.
R.16.19.20-16.19.20.31 PHARMACY AND HOSPITAL PRESCRIPTION AND DISPENSING RECORDS
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A. Prescriptions for schedule II shall be maintained in a separate file. B. In pharmacies without computerized prescription information, prescriptions for schedules II, III, IV and V shall have the name of the dispensing pharmacist and the date filled inscribed on the face of the…