Early Drug Laws
This 1906 law was one of the first to stop the sale of inaccurately labeled drugs.
What is the Pure Food and Drug Act?
This act created the DEA and established drug schedules CI–CV.
What is the Comprehensive Drug Abuse and Control Act (CSA)?
This 1970 act requires child‑resistant packaging for most prescriptions.
What is the Poison Prevention Packaging Act (PPPA)?
This 1984 act sped up generic drug approvals and extended patent terms.
What is the Hatch–Waxman Act?
This 1990 act requires pharmacists to offer to counsel Medicaid patients on new prescriptions.
What is OBRA‑90?
Passed in 1938, this act established the legal definitions of adulteration and misbranding.
What is the Food Drug and Cosmetic Act (FDCA)?
Under federal law, this schedule includes drugs with no accepted medical use and a high potential for abuse.
What is Schedule I?
Name one group exempt from PPPA requirements.
Who are hospitalized patients / a patient or prescriber requesting non–child resistant packaging / nitroglycerin users?
This law defines “dietary supplement” and restricts misleading label claims.
What is DSHEA of 1994?
Under OBRA‑90, pharmacists must perform this review before filling a prescription.
What is a Drug Utilization Evaluation (DUE)?
This 1914 act required a prescription to purchase opium and mandated documentation of opium and coca products.
What is the Harrison Narcotics Act?
These controlled schedules allow five refills in six months.
What are Schedules III, IV, and V?
This act introduced the National Drug Code (NDC) number.
What is the Drug Listing Act of 1972?
This amendment requires drug manufacturers to follow Good Manufacturing Processes (GMP).
What is the Kefauver–Harris Amendment of 1962?
This 1996 act protects patient privacy and defines “covered entities.”
What is HIPAA?
This law required manufacturers to include package inserts and directions for safe use.
What is the FDCA of 1938?
This act reclassified anabolic steroids as Schedule III and removed the requirement to prove muscle growth.
What is the Anabolic Steroid Control Act of 2004?
This 2013 act improved tracking of prescription drugs through barcodes and electronic tracing.
What is the Drug Supply Chain Security Act (DSCSA)?
This act changed the prescription label to “Rx Only” and allowed pharmacists to compound medications under USP standards.
What is the FDA Modernization Act of 1997?
This act prohibits drug sample sales and re-importation into the U.S.
What is the Prescription Drug Marketing Act of 1987?
This 1951 amendment introduced the “federal legend” separating prescription and OTC drugs.
What is the Durham–Humphrey Amendment?
This meth-related act limits purchasers to 3.6 g/day and requires ID and logbook signatures.
What is the Combat Methamphetamine Epidemic Act of 2005?
These two warning label terms—one for addiction risk and one for habit-forming products—were created under the 1938 FDCA.
What are “Warning—May be habit forming” and “adequate directions for use”?
This law encourages drug development for conditions affecting under 200,000 Americans.
What is the Orphan Drug Act of 1983?
This 2003 federal act created Medicare Part D and expanded MTM services.
What is the Medicare Modernization Act?