NMBOP: Part 16, 17, 18, 19 Flashcards
PART 16 SAMPLE DRUG DISTRIBUTION
Q: What is the definition of a “sample” in the context of pharmaceutical regulations?
A: A sample is a drug that is not intended to be sold and is intended to promote the sale of the drug.
Q: What items are prohibited from being bought, sold, traded, bartered, or exchanged according to 16.19.16.8 NMAC?
A: The following items are prohibited from being bought, sold, traded, bartered, or exchanged:
1. Pharmaceutical product samples.
2. Pharmaceutical products sold for export only.
3. Pharmaceuticals purchased by hospitals and/or clinics, including state and local government agencies, for exclusive use within those institutions and not intended for resale.
4. Pharmaceutical products donated or supplied at reduced prices to charitable institutions in the U.S. or abroad for their institutional use.
5. Complementary pharmaceutical product trade packages.
Q: Are there any exceptions to the prohibition on buying, selling, or exchanging pharmaceutical samples?
A: Yes, exceptions include:
1. Sales otherwise permitted by law to affiliated corporations within a health care corporate structure.
2. Sales by bona fide group purchasing arrangements to members.
3. Emergency borrowing or lending between licensed health care facilities.
Q: What are the consequences of violating the regulations related to pharmaceutical sample distribution?
A: Violations of these regulations can result in the revocation of licenses or permits issued by the Board of Pharmacy.
PART 17 DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH
Q: Who is eligible to apply for a research license to conduct projects involving dangerous drugs?
A: Eligible applicants include public agencies, institutions of higher education, private organizations, and individuals for the purpose of conducting research, demonstration, or special projects using dangerous drugs.
Q: What must an applicant provide when applying for a research license for dangerous drugs?
A: The applicant must provide the following information:
1. Name, address, and date of birth of persons involved in handling dangerous drugs, and any felony convictions.
2. Drug protocol, including:
- Formulary of dangerous drugs for research.
- Utilization of the dangerous drug.
- Quantity used per dose or experiment.
- Annual drug purchase amount.
3. Policy and procedure manual, including:
- Drug security: storage area and list of individuals with access.
- Drug procurement: invoices, receipts, and sources.
- Drug usage: records or logs.
- Drug waste/destruction: memorandum report.
- Drug storage area.
- Research protocol: confidentiality of proprietary or trade secrets.
4. Qualifications of the applicant, which may include degrees, higher education, and specialized training.
PART 18 NUCLEAR PHARMACY
“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.
“Nuclear Pharmacy”
means a pharmacy which provides radiopharmaceutical services, and shall be licensed by the Board as a wholesaler or retail pharmacy.
Q: What defines a “Qualified Nuclear Pharmacist”?
A: A “Qualified Nuclear Pharmacist” is a pharmacist currently licensed by the Board who meets either of the following criteria:
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Certification:
- Certified as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties.
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Training and Instruction:
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Experiential Training:
- Attained a minimum of 500 contact hours of experiential training in nuclear pharmacy under the supervision of a qualified nuclear pharmacist. This training must include:
- Procurement of radioactive materials.
- Compounding of radiopharmaceuticals.
- Maintenance of a quality assurance program.
- Dispensing of radiopharmaceuticals.
- Distribution of radiopharmaceuticals.
- Implementation of basic health and safety practices and procedures.
- Provision of information and consultation related to nuclear pharmacy and radiopharmaceuticals.
- Attained a minimum of 500 contact hours of experiential training in nuclear pharmacy under the supervision of a qualified nuclear pharmacist. This training must include:
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Didactic Instruction:
- Completed 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 an ACPE-accredited provider. This instruction must cover:
- Radiation physics and instrumentation.
- Radiation protection.
- Mathematics pertaining to the use and measurement of radioactivity.
- Radiation biology.
- Radiopharmaceutical chemistry.
- Completed 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 an ACPE-accredited provider. This instruction must cover:
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Experiential Training:
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Exemption:
- Any pharmacist 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 the above training and certification requirements.
“Radiopharmaceutical Services”
“Radiopharmaceutical Services” means the procurement, storage, handling, compounding, labeling, quality control testing, dispensing, distribution, transfer, record keeping and disposal of radiochemicals, radiopharmaceuticals and ancillary drugs, and also includes quality assurance procedures, radiological health activities, any consulting activities associated with the use of radiopharmaceuticals, and any other activities required for provision of pharmaceutical care.
“Quality Control Testing”
“Quality Control Testing” means the performance of appropriate chemical, biological and physical tests on compounded radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.
“Quality Assurance Procedures”
“Quality Assurance Procedures” means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including authentication of product history and maintenance of all records as required by pertinent regulatory agencies.
“Authentication of Product History”
“Authentication of Product History” means identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug.
“Radiopharmaceutical”
“Radiopharmaceutical” means any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or protons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term ‘radiopharmaceutical’ also includes any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.
Q: Are the licensing requirements for a nuclear pharmacy separate from general pharmacy licensing requirements in New Mexico?
A: No, the licensing provisions for a nuclear pharmacy are in addition to, and not a substitute for, the general licensing requirements for all pharmacies in New Mexico.
