Pharmacy-Related Federal Laws

Question 0

1906
First law to regulate the development, compounding, distribution, storage, and dispensing of drugs. No false or misleading information on label about the drug strength or purity. No interstate transport or sale of adulterated or misbranded food or drugs.

Answer 0

Pure Food and Drug Act

Question 1

1938
Clearly defined adulteration and misbranding; created the federal Food and Drug Administration (FDA); required that products be safe for human use

Answer 1

Food, Drug, and Cosmetic Act (FDCA)

Question 2

1951
Distinguished between prescription (legend) and nonprescription drugs. Requires that all drug products have usage directions or have the legend “Caution: Federal Law Prohibits without Prescription”; allowed verbal prescription and refill requests to pharmacies by phone.

Answer 2

Durham-Humphrey Amendments to FDCA

Question 3

1962
Requires drugs to be not only safe but effective; requires that pharmaceutical manufacturers file an investigational New Drug Application (INDA) before starting clinical trials on human subjects.

Answer 3

Kefauver-Harris Amendment to FDCA

Question 4

1970
Established the federal Drug Enforcement Agency (DEA), created a schedule of drugs that has the potential for abuse and/or addiction and categorized them into five classes.

Answer 4

Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act)

Question 5

1970
Requires child-resistant containers for most prescription and over-the-counter (OTC) drugs to prevent accidental ingestion and poisoning.

Answer 5

Poison Prevention Packaging Act

Question 6

1972

Requires National Drug Code (NDC) numbers be assigned to every marketed drug.

Answer 6

Drug Listing Act

Question 7

1983
Provides tax incentives for developing and marketing drugs used to treat rare conditions (orphan drugs); established life-long exclusive license for manufacturers that develop orphan drugs

Answer 7

Orphan Drug a Act

Question 8

1984
Streamlined the FDA approval process for marketing generic drugs; extends the term of patents for companies that develop new drugs

Answer 8

Drug Price Competition and Patent Term Restoration Act

Question 9

1987

Prohibits the re-importation of drugs to the US, except by the manufacturer

Answer 9

Prescription Drug Marketing Act

Question 10

1990

Redefined anabolic steroids as Schedule III controlled substance

Answer 10

Anabolic Steroid Control Act

Question 11

1990
Requires pharmacist to engage in drug utilization reviews (DUR); requires technicians to offer patients the option of prescription counseling without charge

Answer 11

Omnibus Budget Reconciliation Act (OBRA)

Question 12

1994
Classifies herbal supplements as food products rather than drugs; prohibits its manufacturers of herbs and dietary supplements from making claims that their products treat or cure any specific disease or illness

Answer 12

Dietary Supplement Health and Education Act (DSHEA)

Question 13

2003
Provides a voluntary prescription drug plan for Medicare patients for additional cost; created the health savings account (HSA)

Answer 13

Medicare Modernization Act

Question 14

2004
Changed federal legend to “Rx only”; allowed pharmacist to compound for individual patients for products not commercially available

Answer 14

FDA modernization Act

Question 15

2005
Restricts sales of drugs used to manufacture methamphetamine, such as pseudoephedrine, ephedrine, and phenylpropanolamine, to behind the pharmacy counter, in some states, only a pharmacist may complete the sale

Answer 15

Combat Methamphetamine Epidemic Act

Question 16

2010
Mandates universal health care coverage for US citizens; provides catastrophic coverage for high-cost illness; prohibits insurers from refusing coverage to those with pre-existing conditions

Answer 16

Patient Protection and Affordable Care Act (ACA)