Federal Pharmacy Law Acts and DEA Forms

Flashcards covering key federal pharmacy laws from 1906 to 1987 and the primary DEA forms used for controlled substance management.

What did the Pure Food and Drug Act of 1906 prohibit?

The sale of adulterated or misbranded drugs.

Which 1938 act required new drugs to be proven safe before marketing?

The Food, Drug, and Cosmetic Act of 1938.

Which amendment first distinguished between prescription and over-the-counter drugs?

The Durham-Humphrey Amendment of 1951.

What additional requirement did the Kefauver-Harris Amendment of 1962 add for drug approval?

Drugs must be proven effective as well as safe.

Which federal law established drug schedules and regulations for controlled substances?

The Controlled Substances Act of 1970.

What did the Poison Prevention Packaging Act of 1970 mandate?

Child-resistant packaging for certain medications.

Which 1972 act required every drug product to have a National Drug Code (NDC) number?

The Drug Listing Act of 1972.

What was the main purpose of the Orphan Drug Act of 1983?

To provide incentives for developing drugs for rare diseases.

Which act encouraged the development of generic drugs by allowing abbreviated new drug applications?

The Drug Price Competition and Patent Term Restoration Act of 1984.

Which 1987 law established regulations for the distribution of prescription drugs?

The Prescription Drug Marketing Act of 1987.

Which DEA form is used to order, transfer, or return Schedule I and II controlled substances?

DEA Form 222.

What is the purpose of DEA Form 224?

Initial registration for retail pharmacies, hospitals/clinics, practitioners, and teaching institutions that handle controlled substances.

Which form is used by practitioners to renew their DEA registration?

DEA Form 224a.

For manufacturers, distributors, and researchers, which form is used for initial DEA registration?

DEA Form 225.

What is DEA Form 225a used for?

Renewal of DEA registration for manufacturers, distributors, and research organizations.

Which DEA form registers a narcotic treatment program such as a methadone clinic?

DEA Form 363.

When renewing a narcotic treatment program’s DEA registration, which form is required?

DEA Form 363a.

Which form is used to record the destruction of controlled substances?

DEA Form 41.

What DEA form must be filed to report the theft or significant loss of controlled substances?

DEA Form 106.

Food, Drug, and Cosmetic Act (FDCA)

: Regulates drug safety and efficacy.

Controlled Substances Act (CSA)

Governs the classification, manufacturing, and dispensing of controlled substances.

Drug Quality and Security Act (DQSA)

: Focuses on the safe compounding and tracking of pharmacy