Pharmacy Laws ⚖❤

Laws that you should probably know for the PTCB

Controlled Substances Act of 1970 (CSA)

• Establishes a federal policy to regulate the manufacturing, distribution, importation, exportation, and the use of regulated substances.

• Places all substances which are classified into schedules I-V based on their potential for abuse, accepted medical use, and safety.

Durham-Humphrey Amendment

• Created distinction between OTC and prescription drugs by representing the need for prescription labels and refills.

Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA, FDCA, FD&C)

• States that all medication products must have directions for use and appropriate safety warnings

• Landmark US law that regulates the safety and labeling of food, drugs, medical devices, and cosmetics

Kefauver-Harris Act of 1962

• Strengthened the FDA’s regulatory powers over drug development and marketing.

• Required drug companies to prove a drug’s effectiveness and safety before it could be approved for sale.

• Mandated informed consent for patients participating in drug trials

Isotretinoin Safety and Risk Management Act, 2004

• Enforced strict guidelines for the prescription of isotretinoin to prevent birth defects and ensure patient safety.

Poison Prevention Packaging Act of 1970 (PPPA)

• Required child-resistant packaging for over-the-counter and prescription medications to reduce accidental poisoning in children.

Orphan Drug Act of 1983

• Incentivized pharmaceutical companies to develop drugs aimed specifically at treating rare diseases

Occupational Safety and Health Act of 1970

• Established standards to ensure a safe and healthy working environment for employees, regulating workplace hazards and promoting safety.

Combat Methamphetamine Epidemic Act of 2005

• established retail sales and purchase transaction limits in grams for scheduled listed chemical products which include pseudoephedrine drug products.

Drug Listing Act of 1972

• requires drug establishments to register with the Food and Drug Administration (FDA) and list all commercially available drugs they manufacture, prepare, or process. This act also mandates the assignment of a unique National Drug Code (NDC) to each drug product.

Federal Hazardous Substances Act 1960

• Regulates the labeling of hazardous substances in household products to protect consumers

• Requires specific warning labels on products deemed hazardous due to their toxicity, flammability, corrosiveness or other harmful properties.

Pure Food and Drug Act of 1906

• aimed to protect consumers by ensuring accurate labeling and prohibiting the sale of unsafe or falsely advertised products

Omnibus Budget Reconciliation Act (OBRA) 1993

• requires pharmacies that fill prescription orders for Medicaid patients to obtain, record, and maintain basic patient info

• mandatory counseling for patients by only a pharmacist

Medicare Drug Improvement and Modernization Act of 2003

• A significant piece of legislation that expanded Medicare benefits to include prescription drug coverage.

• Established Medicare Part D