Pharmacy Laws and Acts

Food, Drug, and Cosmetic Act (FDCA) of 1938

Requires drugs to be safe before marketing; gives FDA authority over drug safety and labeling.

Durham-Humphrey Amendment of 1951

Established the distinction between prescription (Rx) and over-the-counter (OTC) drugs.

Kefauver-Harris Amendment of 1962

Requires drugs to prove BOTH safety and effectiveness before approval.

Comprehensive Drug Abuse Prevention and Control Act of 1970

Created the Controlled Substances Act (CSA) and five federal drug schedules.

Poison Prevention Packaging Act of 1970

Requires child-resistant packaging for covered medications.

Drug Listing Act of 1972

Requires drug manufacturers to register and list their products; associated with the NDC.

Orphan Drug Act of 1983

Encourages development of medications for rare diseases.

OBRA of 1990

Requires Medicaid-related prospective drug reviews (DUR) and offers of pharmacist counseling.

HIPAA of 1996

Protects patient health information (PHI) and medical privacy.

Medicare Prescription Drug Improvement and Modernization Act of 2003

Created Medicare Part D prescription drug coverage.

Combat Methamphetamine Epidemic Act of 2005

Restricts sales of covered pseudoephedrine products; requires ID checks and sales records.

Occupational Safety and Health Act (OSHA) of 1970

Protects employees by establishing workplace health and safety standards.

Anabolic Steroid Control Act of 2004

Classified anabolic steroids as Schedule III controlled substances.

Resource Conservation and Recovery Act (RCRA) of 1976

Regulates hazardous waste management and disposal.

Biologics Price Competition and Innovation (BPCI) Act of 2009

Created an approval pathway for biosimilar and interchangeable biologic products.

DEA Diversion Control Division

Enforces controlled-substance laws and works to prevent drug diversion.

Florida Board of Pharmacy

Regulates pharmacists, pharmacies, and pharmacy practice in Florida.

Florida pharmacy technician requirements

Technicians must be registered and work under pharmacist supervision; they cannot perform pharmacist-only duties.

Florida Controlled Substance Law

Florida Statute Chapter 893; regulates controlled substances, including schedules, prescribing, and dispensing.

FDA Recall Class I

Most serious: reasonable chance of serious health consequences or death.

FDA Recall Class II

May cause temporary or medically reversible health problems; serious harm is unlikely.

FDA Recall Class III

Unlikely to cause adverse health consequences.

Medication Therapy Management (MTM)

Reviews medications, identifies problems and interactions, improves understanding, and supports adherence.

Patient Bill of Rights

Includes privacy, understandable information, participation in care decisions, and respectful treatment.

Tall-Man Lettering

Uses uppercase letters within similar drug names to highlight differences and reduce medication errors.

LASA Drugs

Look-Alike, Sound-Alike drugs; names or appearances can be confused and cause errors.

DEA vs. FDA

DEA regulates controlled substances; FDA oversees drug safety, effectiveness, and approval.