Pharmacy Practice Chapter 02: Pharmacy Law, Regulations, and Standards

Key terms and definitions covering laws, amendments, agencies, and standards discussed in the lecture notes.

patent medicines

Unregulated medicinal products marketed in the 19th–early 20th centuries, often containing opium and alcohol and touted as miracle cures.

Food, Drug, and Cosmetic Act (1938)

U.S. law requiring safety data before marketing drugs and giving the FDA authority to regulate drug safety and labeling.

Kefauver-Harris Amendment (1962)

Amendment requiring evidence of drug efficacy and safety and strengthening manufacturing standards (GMP) for new drugs.

Durham-Humphrey Amendment (1951)

Legislation distinguishing prescription (legend) drugs from OTCs and allowing certain prescriptions to be refilled under specified rules.

adulterated drugs

Drugs that fail to meet official quality, strength, purity, or identity standards.

misbranded drugs

Drugs with false or misleading labeling, including incorrect ingredients, directions, or claims.

legend (Rx) drugs

Drugs that require a prescription and are dispensed only under medical supervision.

Center for Drug Evaluation and Research (CDER)

FDA center responsible for the development and review of new drugs, evaluation of generics, and OTC drug reviews.

Food and Drug Administration (FDA)

U.S. agency that regulates food, drugs, medical devices, and cosmetics to ensure safety and efficacy.

Drug Enforcement Administration (DEA)

Agency that enforces controlled substances laws and determines scheduling of drugs.

National Association of Boards of Pharmacy (NABP)

Professional organization linking state boards of pharmacy; oversees programs like VIPPS.

Verified Internet Pharmacy Practice Sites (VIPPS)

NABP program that accredits and monitors online pharmacies to promote safe practice.

Schedule II drugs

Drugs with high abuse potential and severe dependence; limited to no refills; strict prescribing requirements.

Schedule IV drugs

Drugs with lower abuse potential than Schedule III; limited refills permitted under federal/state law.

behind-the-counter (BTC) medications

Medications (e.g., pseudoephedrine) kept behind the counter; require pharmacist oversight for sale.

child-resistant containers (CRC) standard

Packaging that cannot be opened by 80% of children under 5 and can be opened by most adults.

blanket non-child-resistant request

A patient may request non-child-resistant packaging; blanket requests from providers are generally not allowed.

nitroglycerin packaging exemption

Nitroglycerin products are often exempt from child-resistant packaging due to clinical need.

National Drug Codes (NDC)

10- or 11-digit identifiers that encode manufacturer, product, and packaging information.

Investigational New Drug Application (IND)

FDA process that allows testing of new drugs in humans with safety oversight.

Food and Drug Administration Modernization Act (FDAMA, 1997)

Law allowing certain compounding activities under exemptions and updating FDA oversight practices.

Medicare Part D

Medicare program providing prescription drug coverage for beneficiaries.

HIPAA

Health Insurance Portability and Accountability Act; protects patient health information and privacy.

anabolic steroids (Schedule III)

Steroids placed on Schedule III by the Anabolic Steroid Control Act for illicit use and distribution.

Combat Methamphetamine Epidemic Act (CMEA) of 2005

Law regulating precursors like pseudoephedrine and requiring recordkeeping and sale limits.

Drug Quality and Security Act (DQSA)

2013 act to strengthen regulation of compounding and require certain facility registration and serialization.

What are patent medicines?

Unregulated medicinal products marketed in the 19th–early 20th centuries, often containing opium and alcohol and touted as miracle cures.

What is the Food, Drug, and Cosmetic Act (1938)?

U.S. law requiring safety data before marketing drugs and giving the FDA authority to regulate drug safety and labeling.

What is the Kefauver-Harris Amendment (1962)?

Amendment requiring evidence of drug efficacy and safety and strengthening manufacturing standards (GMP) for new drugs.

What is the Durham-Humphrey Amendment (1951)?

Legislation distinguishing prescription (legend) drugs from OTCs and allowing certain prescriptions to be refilled under specified rules.

What are adulterated drugs?

Drugs that fail to meet official quality, strength, purity, or identity standards.

What are misbranded drugs?

Drugs with false or misleading labeling, including incorrect ingredients, directions, or claims.

What are legend (Rx) drugs?

Drugs that require a prescription and are dispensed only under medical supervision.

What is the Center for Drug Evaluation and Research (CDER)?

FDA center responsible for the development and review of new drugs, evaluation of generics, and OTC drug reviews.

What is the Food and Drug Administration (FDA)?

U.S. agency that regulates food, drugs, medical devices, and cosmetics to ensure safety and efficacy.

What is the Drug Enforcement Administration (DEA)?

Agency that enforces controlled substances laws and determines scheduling of drugs.

What is the National Association of Boards of Pharmacy (NABP)?

Professional organization linking state boards of pharmacy; oversees programs like VIPPS.

What are Verified Internet Pharmacy Practice Sites (VIPPS)?

NABP program that accredits and monitors online pharmacies to promote safe practice.

What are Schedule II drugs?

Drugs with high abuse potential and severe dependence; limited to no refills; strict prescribing requirements.

What are Schedule IV drugs?

Drugs with lower abuse potential than Schedule III; limited refills permitted under federal/state law.

What are behind-the-counter (BTC) medications?

Medications (e.g., pseudoephedrine) kept behind the counter; require pharmacist oversight for sale.

What is the child-resistant containers (CRC) standard?

Packaging that cannot be opened by 80% of children under 5 and can be opened by most adults.

What is a blanket non-child-resistant request?

A patient may request non-child-resistant packaging; blanket requests from providers are generally not allowed.

What is the nitroglycerin packaging exemption?

Nitroglycerin products are often exempt from child-resistant packaging due to clinical need.

What are National Drug Codes (NDC)?

10- or 11-digit identifiers that encode manufacturer, product, and packaging information.

What is an Investigational New Drug Application (IND)?

FDA process that allows testing of new drugs in humans with safety oversight.

What is the Food and Drug Administration Modernization Act (FDAMA, 1997)?

Law allowing certain compounding activities under exemptions and updating FDA oversight practices.

What is Medicare Part D?

Medicare program providing prescription drug coverage for beneficiaries.

What is HIPAA?

Health Insurance Portability and Accountability Act; protects patient health information and privacy.

What are anabolic steroids (Schedule III)?

Steroids placed on Schedule III by the Anabolic Steroid Control Act for illicit use and distribution.

What is the Combat Methamphetamine Epidemic Act (CMEA) of 2005?

Law regulating precursors like pseudoephedrine and requiring recordkeeping and sale limits.

What is the Drug Quality and Security Act (DQSA)?

2013 act to strengthen regulation of compounding and require certain facility registration and serialization.