U.S. Pharmacy Law & Drug Recall Overview

15 Question-and-Answer flashcards covering major U.S. pharmacy legislation from 1906 to 2005 and FDA drug-recall classifications.

What did the 1906 Federal Food and Drug Act prohibit?

The sale of adulterated or mislabeled food, drinks, and drugs.

Under the 1914 Harrison Narcotic Act, what was required to obtain or transport opium?

A valid prescription; the act limited non-medical access to opium.

Which key provisions were added by the 1938 Food, Drug, and Cosmetic Act?

Extended regulation to cosmetics, made misbranding/adulteration illegal, required package inserts, and mandated proof of drug safety under FDA guidelines before marketing.

What major distinction did the 1951 Durham-Humphrey Amendment create?

It separated legend (Rx) drugs from OTC drugs and required the label: “Caution: Federal law prohibits dispensing without a prescription.”

What requirements did the 1962 Kefauver-Harris Amendment impose on manufacturers?

Drugs must be proven safe and effective, companies must register annually, report adverse reactions, and undergo inspections every two years.

Which agency was formed by the 1970 Comprehensive Drug Abuse Prevention and Control Act, and what scheduling system did it create?

The Drug Enforcement Administration (DEA); it placed controlled substances into Schedules I–V based on abuse potential (I = highest, V = lowest).

What packaging standard was mandated by the 1970 Poison Prevention Packaging Act?

Child-resistant (childproof) containers for most prescription drugs, with exceptions such as nitroglycerin used in emergencies.

What is the purpose of the 1983 Orphan Drug Act?

To encourage research, development, and marketing of drugs for rare diseases.

What prohibition is established by the 1987 Prescription Drug Marketing Act?

The sale, trade, or purchase of prescription drug samples, and it requires reporting of adverse reactions to the FDA.

What counseling requirement did the 1990 Omnibus Budget Reconciliation Act (OBRA) impose on pharmacists?

Pharmacists must offer to counsel patients on all new prescriptions and provide drug information with each dispensing.

What protections are provided under the 1996 Health Insurance Portability and Accountability Act (HIPAA)?

Rules for privacy and security of patient health information, limitations on who may access it, and portability of health insurance for employees changing jobs.

According to the 2005 Combat Methamphetamine Epidemic Act, what limits apply to pseudoephedrine purchases?

A maximum of 3.6 g per day or 7.5 g per 30 days; purchasers must show ID and transactions are recorded electronically or in a logbook.

What is the primary purpose of lot numbers during a drug recall?

They identify which specific batches are affected so pharmacies can remove them from inventory and notify patients when necessary.

How is a Class I drug recall defined?

The product could cause serious harm or death; pharmacies must attempt to notify each patient who received the drug.

How do Class II and Class III drug recalls differ from Class I?

Class II: Serious harm is unlikely; recall does not reach the consumer level. Class III: Unlikely to cause adverse effects; also does not reach consumers.