Pharmacy Laws and Regulations

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Established the principle of protected health information (PHI), specifically all "individually identifiable health information".

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

Due to the diversion of pseudoephedrine as an ingredient in the street drug methamphetamine, access to was limited to be purchased behind the counter (BTC)

3.6 g in a calendar day 9 g per 30 days - retail 7.5 g per 30 days - mail order

Logbook and ID requirement for purchase Training course for employees

Drug Listing Act of 1972 (including elements of the NDC)

Every drug has a unique 10 digit number divided into three segments called the national drug code

Food and Drug Act of 1906

Prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs.

Government pre approval of drugs is required.

Stop the sale of inaccurately labeled drugs.

Omnibus Budget Reconciliation Act of 1990 (OBRA 90)

Pharmacist must offer counsel (at time of purchase) for all Medicaid patients who receive new prescriptions. (now expanded to all patients)

Requires drug utilization evaluation (DUE) - a review of all prescriptions to determine appropriateness

Durham-Humphrey Amendment of 1951

Identified drugs which required a physicians order and supervision.

Created a distinction between "OTC" and "Legend Drugs"

Required legend drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription."

Federal Food, Drug, and Cosmetic Act of 1938

Stricter wording than the Food and Drug act of 1906.

Clarification about misbranding and adulteration definitions.

Companies must include package inserts regarding safe use.

Poison Prevention Packaging Act of 1970 (PPPA)

To protect children less than 5 years old from accidental poisoning

Required child-resistant closure on almost all OTC, Rx and hazardous household products

Drug products intended to be dispensed in their manufacture packaging must meet PPPA req's

Kefauver-Harris Amendment of 1962

Required drug manufacturers to provide proof of the effectiveness and safety of their drugs based on the scientific method and obtain approval from the FDA prior to commercial sales.

Orphan Drug Act of 1983

Provided incentives for the development of orphan drugs for treatment of rare diseases

Medicare Modernization Act of 2003

Expanded to include low income families Introduced an entitlement benefit for prescriptions (Medicare part D)

Created Tax free savings accounts for pharmaceutical purposes

Anabolic Steroid Act of 1990

Identified anabolic steroids as a separate drug class and categorized over two dozen drugs as controlled substances

Drug Supply Chain Security Act (DSCSA) a.k.a. Track and Trace (2013)

Enhance FDA's ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful

Requires development of electronic system to identify and trace certain prescription drugs as they are distributed in the United States.

Regulation: USP <800>

Safe handling and disposal practices for hazardous drugs issued by the United States Pharmacopeia

Regulation: USP <797>

Sterile compounding regulation issued by the United States Pharmacopeia

aseptic techniques and flow hoods

Regulation: USP <795>

Non-sterile compounding requirements issued by the United States Pharmacopeia