Pharmacy Law & Regulatory Agencies

FDA (Food and Drug Administration)

Regulates the safety | efficacy | and labeling of drugs | foods | and cosmetics

DEA (Drug Enforcement Administration)

Enforces the Controlled Substances Act (CSA) and prevents illegal drug distribution

BOP (State Board of Pharmacy)

Licenses pharmacy personnel | registers pharmacies | and enforces state-specific laws

USP (United States Pharmacopeia)

Sets public quality standards for prescription and over-the-counter medicines

USP Chapter 795

Regulations and standards for Non-Sterile Compounding (ointments | creams | oral liquids)

USP Chapter 797

Regulations and standards for Sterile Compounding (IV bags | eye drops | injections)

USP Chapter 800

Regulations and standards for Hazardous Drugs (handling chemo drugs to protect workers and patients)

Pure Food and Drug Act of 1906

Prohibited the sale of misbranded or adulterated food and drugs

Food Drug and Cosmetic Act of 1938

Required manufacturers to prove drug safety before marketing | created after Elixir Sulfanilamide tragedy

Durham-Humphrey Amendment of 1951

Established two distinct classes of drugs: Prescription (Legend) and Over-the-Counter (OTC)

Kefauver-Harris Amendment of 1962

Required drugs to be proven both safe AND effective before hitting the market

Poison Prevention Packaging Act of 1970

Required child-resistant packaging on most prescription medications

Omnibus Budget Reconciliation Act of 1990 (OBRA-90)

Mandated that pharmacists perform drug utilization reviews (DUR) and offer patient counseling

Combat Methamphetamine Epidemic Act of 2005

Regulated OTC sales of pseudoephedrine | ephedrine | and phenylpropanolamine

Pseudoephedrine Daily Purchase Limit

Maximum of 3.6 grams per day per customer

Pseudoephedrine 30-Day Purchase Limit

Maximum of 9.0 grams per 30-day period per customer

Adulteration Definition

A drug that contains decomposed materials | is prepared in unsanitary conditions | or differs in purity from standards

Misbranding Definition

A drug label that is false | misleading | missing directions | or lacks mandatory warning statements

Class I Recall

Dangerous product that will cause severe health problems or death

Class II Recall

Temporary or reversible health problems with a remote chance of serious consequences

Class III Recall

Product not likely to cause adverse health consequences (e.g. minor labeling error)