Pharmacy Regulations Overview

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Questions and Answers

What is the maximum beyond-use date for ordinary prescription vials?

One year from the date the drug is dispensed (correct)

Two years from the date the drug is dispensed

The expiration date on the manufacturer's container (correct)

The date of manufacturing

Which of the following can be a permissible structure/function claim for dietary supplements?

Promotes muscle growth for everyone

Calcium supplement with vitamin D for strong bones (correct)

Cures calcium deficiency instantly

Helps prevent heart disease in all individuals

What essential statement must be included on any dietary supplement label with a permissible claim?

This statement has not been evaluated by the FDA (correct)

This product is approved by the FDA

Caution: May cause side effects

Consult your doctor before use

What defines cosmetics according to the Food, Drug, and Cosmetic Act?

Products for cleansing and beautifying without affecting body structure Signup and view all the answers

Which of the following is NOT a component that can be found in dietary supplements?

Antibodies Signup and view all the answers

What must manufacturers do at least 75 days prior to marketing a dietary supplement?

Notify the FDA and provide safety basis Signup and view all the answers

How is a product classified as a drug-cosmetic rather than just a cosmetic?

If it claims to affect the structure or function of the body Signup and view all the answers

Which of the following is a function of dietary supplements?

Supplement dietary intake Signup and view all the answers

What are pharmaceutical alternatives?

Drug products that contain the same therapeutic moiety but are different salts or dosage forms Signup and view all the answers

Which codes indicate that drug products are therapeutically equivalent?

AA and AB Signup and view all the answers

Which of the following statements is true regarding products with a 'B' equivalence code?

They are not therapeutically equivalent due to issues with dosage forms. Signup and view all the answers

What is required for veterinary products used in food-producing animals?

They must gain approval through the New Animal Drug Application. Signup and view all the answers

Which agency is responsible for regulating vaccines and biologics?

CBER Signup and view all the answers

What is the primary focus of the FDA in the pharmacological context?

To ensure the safety and efficacy of pharmaceutical products. Signup and view all the answers

What is necessary before a new drug can be marketed?

Submission and approval through clinical tests are required. Signup and view all the answers

How does the regulation of OTC drugs differ from prescription drugs?

OTC drugs must conform to an OTC monograph. Signup and view all the answers

What is a requirement for using investigational drugs in the general population?

A treatment protocol must be submitted to the FDA. Signup and view all the answers

Which statement about tamper evident packaging is incorrect?

The packaging must be easy to duplicate. Signup and view all the answers

What percentage of children under 5 years of age should not be able to open child-resistant packaging?

80% Signup and view all the answers

What does the Poison Prevention Packaging Act require for all legend drugs?

Child-resistant caps. Signup and view all the answers

Which of the following products is exempt from child-resistant packaging?

Erythromycin ethylsuccinate granules for oral suspension under 8 g. Signup and view all the answers

Which of these investigational drug criteria is not required?

Availability of multiple alternative treatments. Signup and view all the answers

What is the necessary condition for a drug to be considered an investigational new drug?

It must be approved and used within a controlled clinical trial. Signup and view all the answers

What is one characteristic of tamper evident packaging?

It provides evidence of tampering. Signup and view all the answers

Which types of practitioners are permitted to dispense controlled substances in the course of their professional practice?

Physicians, dentists, and veterinarians Signup and view all the answers

What happens to an individual who knowingly dispenses an invalid prescription order?

They can be subject to criminal and/or civil penalties Signup and view all the answers

What is the status of a prescription written for office stock or 'medical bag use'?

It is not a valid request for general dispensing Signup and view all the answers

Under what condition can a prescription for methadone be filled?

Only for analgesic purposes Signup and view all the answers

What requirement is necessary for a practitioner to administer or dispense a narcotic to a narcotic dependent person?

They must hold a separate registration for the Narcotic Treatment Program Signup and view all the answers

What form must a pharmacy request to register for the first time?

DEA Form-224.A Signup and view all the answers

How often must pharmacy registration be renewed?

Every three years Signup and view all the answers

What should a pharmacy do if it does not receive its renewal form within 45 days before expiration?

Contact the Registration Unit of DEA Signup and view all the answers

Which of the following are exempt from registering separately?

Satellite Pharmacies Signup and view all the answers

What must be kept available for official inspection at a pharmacy?

Certificate of Registration Signup and view all the answers

What is the consequence of not consulting the Secretary of the HHS for scheduling a drug?

It may lead to public safety hazards Signup and view all the answers

Which form is used for renewing pharmacy registration?

DEA Form-224a Signup and view all the answers

What is a requirement for individual practitioners to administer controlled substances under a hospital's registration?

They must act within the usual course of professional practice Signup and view all the answers

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.
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

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.
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.