54,212 sections across 3,422 New Mexico regulatory chapters.
R.16.19.21-16.19.21.14 FACILITY INSPECTION
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The board of pharmacy may direct the drug inspector to inspect the facilities prior to approval of any registration application filed under this part of any wholesaler, manufacturer, or distributor, for security provisions and other applicable standards as required by the Drug Pr…
R.16.19.21-16.19.21.15 PROCEDURE SUMMARY
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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. This summary shall include, but is not limited to, the names of individuals engaged in the project, the name or names of the precursor…
R.16.19.21-16.19.21.16 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 drug precursors in possession of analytical laborato…
R.16.19.21-16.19.21.17 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 federal, state and local law relating …
R.16.19.21-16.19.21.18 TRANSFER AND TERMINATION OF REGISTRATION
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A. Registration shall terminate if and when a registrant dies, discontinues business or professional practice, has his professional license revoked or suspended, or changes his name or address as shown on the registration. In such instance, the registrant or his estate shall noti…
R.16.19.21-16.19.21.19 INVENTORY RECORDS
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All registrants are required to keep procurement records in a readily retrievable manner for 3 years.
R.16.19.21-16.19.21.2 SCOPE
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All individuals and entities that manufacture, possess, transfer, or transport drug precursors.
R.16.19.21-16.19.21.20 ORDER FORMS (INVOICES) AS RECORDS
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Order forms (invoices) for drug precursors shall be deemed proper records of receipt if the purchaser records on their copy the number of commercial or bulk containers furnished of each item, the date received and the name of person receiving the order.
R.16.19.21-16.19.21.21 PROCUREMENT RECORDS
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Procurement records, and all other records, must be kept at the registered location and must be available for inspection.
R.16.19.21-16.19.21.22 REPORT OF LOSS OR THEFT OF A DRUG PRECURSOR
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A significant loss or theft of a drug precursor shall be reported in writing to the Board of Pharmacy. "Significant loss" includes suspected diversions, in-transit losses or any other unexplained loss.
R.16.19.21-16.19.21.23 DISTRIBUTION RECORDS
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All wholesaler, manufacturer, or distributor registrants shall include the following in distribution records for drug precursors under this part: A. purchaser's name, address and telephone number, and drug precursor registration number or other license number issued by the board …
R.16.19.21-16.19.21.24 DISPOSITION OF DAMAGED, OUTDATED, OR UNWANTED DRUG PRECURSORS
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Any registrant in possession of any drug precursor and desiring to dispose of such substance must abide by any applicable federal, state, local law or regulation for the destruction of such substance. This destruction must be witnessed by at least one law enforcement officer cert…
R.16.19.21-16.19.21.25 DISTRIBUTION UPON TRANSFER OR DISCONTINUANCE OF BUSINESS
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A. Upon transfer of a business from one owner to another, the owner may dispose of the drug precursors in the following manner: (1) have the drug precursor destroyed as discussed in 16.19.21.24 NMAC; (2) transfer the drug precursors to the new owner. All records required to be ke…
R.16.19.21-16.19.21.26 SECURITY REQUIREMENTS
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A. All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of drug precursors. B. In evaluating the overall security system of a registrant or applicant, the following factors may be considered: (1) the type of activity;…
R.16.19.21-16.19.21.27 HEARINGS, DENIAL OF REGISTRATION, REVOCATION OR SUSPENSION OF REGISTRATION
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Proceedings to suspend or revoke a registration or to refuse renewal of a registration shall be held pursuant to the Uniform Licensing Act.
R.16.19.21-16.19.21.28 ADMINISTRATIVE INSPECTION - DEFINED
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Administrative inspection means: the inspection of any place where registrants are permitted to hold, manufacture, compound, process, sell, deliver, transport, or otherwise dispose of any drug precursors. When authorized by an administrative inspection warrant, the inspector may:…
R.16.19.21-16.19.21.29 VOLUNTARY CONSENT TO INSPECTION
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The Board inspector will ask the registrant to voluntarily consent to the inspection. He will inform the registrant of his constitutional rights to an inspection warrant. However, if the registrant consents to inspection without warrant, the inspector will obtain a signed consent…
R.16.19.21-16.19.21.3 STATUTORY AUTHORITY
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Pursuant to 30-31B-6 of the Drug Precursor Act, 30-31B-1 through 30-31-B-18 NMSA 1978, the Board of Pharmacy may promulgate regulations and charge reasonable fees relating to the licensing and control of the manufacture, possession, transfer and transportation of drug precursors.…
R.16.19.21-16.19.21.30 WRITTEN CONSENT
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A. The written consent shall contain the following information: (1) that the owner, or agent in charge of the premises has been informed of his constitutional rights not to have an administrative inspection made without an administrative inspection warrant; (2) of his right to re…
R.16.19.21-16.19.21.31 ADMINISTRATIVE WARRANT
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A. A copy of the administrative warrant need not be given to the registrant unless items are seized or confiscated. B. To serve the warrant, all that is required, is to announce possession of it, the contents of the warrant need not e stated to the person upon whom the warrant is…
R.16.19.21-16.19.21.32 CONSENT
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Unless the person in charge of the premises so consents in writing, these regulations shall not extend to financial data; pricing data; or sales data other than shipping dates.
R.16.19.21-16.19.21.33 ADMINISTRATIVE WARRANT - NOT REQUIRED
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An administrative warrant shall not be required for a new facility applying for initial registration under the Drug Precursor Act, or in any situation where a warrant is not constitutionally required.
R.16.19.21-16.19.21.34 ADMINISTRATIVE WARRANT - REFUSAL
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If a registrant or any person subject to the Drug Precursor Act refuses to permit execution of an administrative warrant or impedes the inspection in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of the Drug Precursor Act.
R.16.19.21-16.19.21.35 CONTROLLED SUBSTANCE PRECURSORS
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The following substances are designated as immediate precursors used in the manufacture of controlled substances: A. phenyl acetone; B. ephedrine; C. phenyl-2-propanone; D. norephedrine; E. ethyl-1-methyl butyl diethyl malonate; F. allyl-1-methyl butyl diethyl malonate; G. hydrox…
R.16.19.21-16.19.21.4 DURATION
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Permanent.
R.16.19.21-16.19.21.5 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.16.19.21-16.19.21.6 OBJECTIVE
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The objective of Part 21 of Chapter 19 is to protect the public health and welfare of the citizens of New Mexico by establishing effective controls against unlawful diversion of drug precursors.
R.16.19.21-16.19.21.7 DEFINITIONS
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[RESERVED]
R.16.19.21-16.19.21.8 PERSONS REQUIRED TO REGISTER
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A. The board shall license an applicant to manufacture, possess, transfer or transport drug precursors unless it determines that the issuance of that license would be inconsistent with the public interest. In determining the public interest, the board may consider the following f…
R.16.19.21-16.19.21.9 REGISTRATION AND EXPIRATION DATE
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A. Any person who is required to be registered under this part and who is not registered may apply for registration at any time. B. The license for persons required to register under this part shall be renewed bi-ennially before the last day of December.
R.16.19.22-16.19.22.1 ISSUING AGENCY
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Board of Pharmacy.
R.16.19.22-16.19.22.10 RATIO OF TECHNICIANS TO PHARMACISTS
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A. The permissible ratio of pharmacy technicians to pharmacists on duty is to be determined by the pharmacist in charge. B. The board reserves the right to impose a ratio of pharmacy technicians to pharmacists if circumstances so dictate.
R.16.19.22-16.19.22.11 IMPROPER ACTIVITIES OF PHARMACY TECHNICIANS
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A. The supervising pharmacist and the pharmacist-in-charge are responsible for the actions of pharmacy technicians. Performance of tasks by the pharmacy technician and support personnel outside the limits of the regulations that are authorized by the supervising pharmacist shall …
R.16.19.22-16.19.22.12 IDENTIFICATION OF PHARMACY PERSONNEL
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All personnel in pharmacy restricted area shall wear an identification badge which must include name and job title.
R.16.19.22-16.19.22.13 RESERVED
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R.16.19.22-16.19.22.14 REGISTRATION OF PHARMACY TECHNICIANS
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A. Application (and required registration fee) shall be submitted to the board prior to performing any technician duties. Non-certified pharmacy technicians must: (1) Complete requirements for certified pharmacy technician within (1) one year of original application. (2) Not re-a…
R.16.19.22-16.19.22.15 CHANGE OF ADDRESS
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Pharmacy technicians shall report in writing or through the online process available on the board's website of any change of address or employment to the board within ten (10) days.
R.16.19.22-16.19.22.16 PHARMACY TECHNICIAN ADMINISTRATION OF VACCINES
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A certified pharmacy technician may administer vaccines prescribed by and under the direct supervision of a New Mexico licensed pharmacist with current immunization prescriptive authority "qualified pharmacist," if all requirements of this section are met. A. Training and educati…
R.16.19.22-16.19.22.2 SCOPE
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All Pharmacy technicians and non-technicians supportive personnel, supervising pharmacists and pharmacists in charge of entities that utilize supportive personnel.
R.16.19.22-16.19.22.3 STATUTORY AUTHORITY
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Subsection A of Section 61-11-6 NMSA 1978 authorizes the Board of pharmacy to register and regulate qualifications, training and permissible activities of pharmacy technicians.
R.16.19.22-16.19.22.4 DURATION
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Permanent.
R.16.19.22-16.19.22.5 EFFECTIVE DATE
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June 27, 2001, unless a later date is cited at the end of a section.
R.16.19.22-16.19.22.6 OBJECTIVE
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The objective of Part 22 of Chapter 19 is to promote responsive delivery of pharmaceutical products and services to the public by establishing standards for training and supervision of support personnel and limitations on their use.
R.16.19.22-16.19.22.7 DEFINITIONS
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A. "Direct supervision" means that the pharmacist onsite shall observe and direct to a degree sufficient to assure the accurate completion of the activities of the pharmacy technicians and must provide a final check of all aspects of the prepared product and document the final ch…
R.16.19.22-16.19.22.8 PERMISSIBLE ACTIVITIES
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Pharmacy technician activities under the direct supervision of a pharmacist shall be limited to tasks enumerated in policies and procedures implemented by the pharmacist-in-charge that do not require professional judgment.
R.16.19.22-16.19.22.9 TRAINING AND EDUCATION
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A. The pharmacist-in-charge shall ensure that the pharmacy technician has completed initial training which includes: (1) federal and state laws and regulations that affect pharmacy practice; specific regulations which address the use of supportive personnel and technicians; (2) e…
R.16.19.23-16.19.23.1 ISSUING AGENCY
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New Mexico Board of Pharmacy.
R.16.19.23-16.19.23.10 INITIAL ACTION
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Upon determination that an applicant or licensee appears on the certified list, the board shall: A. Commence a formal proceeding under section 11 of part 23 to take the appropriate action under section 8 of part 23; or B. For current licensees only, informally notify the licensee…
R.16.19.23-16.19.23.11 NOTICE OF CONTEMPLATED ACTION
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Prior to taking any action specified in section 8 of part 23, the board shall serve upon the applicant or licensee a written notice stating that: A. The board has grounds to take such action, and that the board shall take such action unless the licensee or applicant: (1) mails a …
R.16.19.23-16.19.23.12 EVIDENCE AND PROOF
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In a hearing under this section, relevant evidence is limited to the following: A. a statement of non-compliance is conclusive evidence that requires the board to take the appropriate action under section 8 of part 23, unless B. the applicant or licensee provides the board with a…