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Questions and Answers
What is the maximum beyond-use date for ordinary prescription vials?
Which of the following can be a permissible structure/function claim for dietary supplements?
What essential statement must be included on any dietary supplement label with a permissible claim?
What defines cosmetics according to the Food, Drug, and Cosmetic Act?
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Which of the following is NOT a component that can be found in dietary supplements?
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What must manufacturers do at least 75 days prior to marketing a dietary supplement?
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How is a product classified as a drug-cosmetic rather than just a cosmetic?
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Which of the following is a function of dietary supplements?
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What are pharmaceutical alternatives?
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Which codes indicate that drug products are therapeutically equivalent?
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Which of the following statements is true regarding products with a 'B' equivalence code?
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What is required for veterinary products used in food-producing animals?
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Which agency is responsible for regulating vaccines and biologics?
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What is the primary focus of the FDA in the pharmacological context?
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What is necessary before a new drug can be marketed?
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How does the regulation of OTC drugs differ from prescription drugs?
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What is a requirement for using investigational drugs in the general population?
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Which statement about tamper evident packaging is incorrect?
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What percentage of children under 5 years of age should not be able to open child-resistant packaging?
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What does the Poison Prevention Packaging Act require for all legend drugs?
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Which of the following products is exempt from child-resistant packaging?
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Which of these investigational drug criteria is not required?
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What is the necessary condition for a drug to be considered an investigational new drug?
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What is one characteristic of tamper evident packaging?
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Which types of practitioners are permitted to dispense controlled substances in the course of their professional practice?
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What happens to an individual who knowingly dispenses an invalid prescription order?
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What is the status of a prescription written for office stock or 'medical bag use'?
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Under what condition can a prescription for methadone be filled?
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What requirement is necessary for a practitioner to administer or dispense a narcotic to a narcotic dependent person?
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What form must a pharmacy request to register for the first time?
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How often must pharmacy registration be renewed?
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What should a pharmacy do if it does not receive its renewal form within 45 days before expiration?
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Which of the following are exempt from registering separately?
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What must be kept available for official inspection at a pharmacy?
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What is the consequence of not consulting the Secretary of the HHS for scheduling a drug?
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Which form is used for renewing pharmacy registration?
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What is a requirement for individual practitioners to administer controlled substances under a hospital's registration?
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Study Notes
Prescription Vials Beyond Use Dates
- For ordinary prescription vials, the beyond-use date should not be later than the expiration date on the manufacturer's container or one year from the date the drug is dispensed - whichever is earlier.
Dietary Supplements
- Dietary supplements include vitamins, amino acids, minerals, herbs, dietary substances, concentrates, metabolites, constituents, extracts, or combinations of the above.
- Permissible structure/function claims for dietary supplements include descriptions of the role of the supplement, the mechanism of action, the benefit of consumption, and the benefit of a classic nutrient deficiency disease, provided the prevalence of the disease in the United States is stated.
- If a dietary supplement label contains a permissible claim, it must include the statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
- Manufacturers must notify the FDA at least 75 days prior to marketing a dietary supplement and provide their basis for believing the supplement will be reasonably safe.
Cosmetics
- Cosmetics are articles intended for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or function.
- Cosmetics intended to treat or prevent disease or alter a body function are considered drug products.
- The key to determining whether a product is a cosmetic or a drug-cosmetic product is the product's claim. If the label claims the product will treat or prevent disease, it is a drug-cosmetic product.
Pharmaceutical Alternatives
- Pharmaceutical alternatives are drug products that contain the same therapeutic moiety but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths.
- The Orange Book provides therapeutic equivalence evaluations for approved drug products.
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A designation indicates therapeutic equivalence to other pharmaceutically equivalent products:
- AA - Products in conventional dosage forms without bioequivalence problems.
- AB - Products with actual or potential bioequivalence problems that have been resolved in vivo or in vitro.
- B designation indicates products are not therapeutically equivalent, usually due to dosage form issues and not active ingredients.
- In Pennsylvania, AA and AB drug products are considered equivalent and can be substituted unless they have a narrow therapeutic range (like Coumadin and Lanoxin). B drug products are not substitutable.
Biological Products
- Biological products include vaccines, various toxoids, skin test substances, blood and blood products for transfusion.
- A manufacturer license is issued by the Center for Biologics Evaluation and Research (CBER).
- Biosimilars are unique biological drugs from living organisms using recombinant technology. They are highly similar to the reference product.
Veterinary Products
- Veterinary products must obtain approval through a New Animal Drug Application (NADA).
- If used in food-producing animals, all edible products must be free of unsafe residues.
- Flea control products are regulated by the EPA (topical) and FDA (oral).
Regulation of Pharmaceutical Products
- Pre-market Requirements: Clinical testing and FDA approval required for prescription drugs; conforming to OTC monographs for OTC drugs; conforming to the Homeopathic Pharmacopeia for homeopathic drugs; and FDA notification for dietary supplements.
- Post-market Review: FDA review for prescription and homeopathic Rx drugs, FTC review for OTC drugs, and FTC review for dietary supplements.
- Regulation of Advertising: FDA for prescription and homeopathic Rx drugs, FTC for OTC drugs and dietary supplements.
- Current Good Manufacturing Practices (CGMP): Required for all categories of pharmaceutical products.
Drug Approval Process
- Before a new drug can be marketed, federal law requires submission and approval. This process begins with pre-clinical testing and progresses through clinical trials.
- Although the FDA discourages it, prescribers can prescribe drugs for off-label indications, and pharmacies can exercise professional discretion in dispensing such prescriptions.
Investigational Drugs
- Investigational drugs may be used in the general population under specific conditions:
- A treatment protocol must be submitted to the FDA.
- The drug must be for a serious or immediately life-threatening disease.
- No comparable or satisfactory alternative treatment must be available.
- The drug must be an approved investigational new drug being used in a controlled clinical trial, and the sponsor of the trial is seeking approval.
Packaging
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Tamper-Evident Packaging:
- Over-the-counter (OTC) medications must be packaged in tamper-evident containers.
- The container must have one or more indicators or barriers to entry to provide evidence of tampering.
- The packaging should be difficult to duplicate.
- Two-piece hard gelatin capsules must be sealed with tamper-evident technology.
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Child-Resistant Packaging:
- The Poison Prevention Packaging Act requires child-resistant caps on all legend drugs.
- At least 80% of children under 5 years of age cannot open these containers, and 90% of adults can.
- Physicians, patients, or heads of households may request non-child-resistant packaging in writing or orally.
- Several drug products are exempted from child-resistant packaging requirements.
DEA Registration (Pharmacies)
- Pharmacies seeking to register for the first time must request DEA Form-224.
- Hospitals do not need to separately register for decentralized pharmacy services or satellite pharmacies if they are part of the same structure.
- The Attorney General (AG) may place a drug into Schedule I without consulting the Secretary of Health and Human Services (HHS) to avoid an "imminent hazard to public safety."
- The Certificate of Registration must be maintained at the registered location and kept available for official inspection.
- The DEA will accept an affidavit of pharmacy license to process the application faster.
DEA Registration (Renewal)
- Pharmacy registration must be renewed every three years.
- Pharmacies seeking to renew their registration use DEA Form-224a.
- The renewal form is automatically sent to the address on the current registration certificate.
- If the renewal form is not received within 45 days before the expiration of the current certificate, the pharmacy should contact the Registration Unit of the DEA.
- Manufacturers and distributors must register every year due to their higher volume.
DEA Registration (Exemption)
- Individual practitioners (physicians, dentists, veterinarians, etc.), interns, residents, or foreign-trained physicians who are agents or employees of a hospital or other institution may administer, dispense, and prescribe controlled substances under the registration of the hospital or institution, provided that:
- The individual is acting within the usual course of professional practice.
- The individual is acting within the scope of their employment.
- The individual is authorized to dispense, administer, or prescribe by the jurisdiction in which they are practicing.
- The institution by which the practitioner is employed verifies authorization to dispense, administer, or prescribe by the jurisdiction.
Individual Practitioners: Dispensing, Administering, and Prescribing
- An individual practitioner does not include a pharmacist or pharmacy.
- A prescription written for office stock or "medical bag use" is not a valid request for controlled substances.
- A prescription for Methadone cannot be filled unless it is for analgesic purposes.
- A practitioner may administer or dispense, but not prescribe, a narcotic drug in any schedule to a narcotic-dependent person for the purpose of maintenance or detoxification treatment if the practitioner is separately registered with the Attorney General to conduct a Narcotic Treatment Program.
Invalid Prescription Orders
- Individuals knowingly dispensing an invalid prescription order, as well as the individual issuing it, can be subject to criminal and/or civil penalties and administrative sanctions.
- Chiropractors, psychologists, and opticians cannot prescribe controlled substances.
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Description
This quiz explores key regulations regarding prescription vials, including beyond-use dates, and dietary supplements. Understand the guidelines for permissible claims and labeling requirements for these products. Perfect for pharmacy students and professionals looking to reinforce their knowledge.
