Pharmacy/drug laws and Reg. Agencies

1906: The Pure Food and Drug Act (PFDA)

Required all foods and drugs to meet a standard of strength and purity.

1914: The Harrison Narcotic Act

Regulated drugs that produce or sustain physical and psychological dependence, like Opium.

1938: The Federal Food, Drug and Cosmetic Act (FFDCA)

Manufacturers of drugs and cosmetics must prove that their products are safe.

1951: The Durham-Humphrey Amendment to the FFDCA

Clarified the distinction between prescription and over-the-counter (OTC) drugs. Required physician consent for refills.

1962: The Kefauver-Harris Amendment to the FFDCA

Required drug manufacturers to prove the safety and efficacy of their products before approval by the FDA for marketing.

1970: Poison Prevention Packaging Act

Requires child-proof packaging for safety.

1970: Controlled Substances Act (CSA)

Classified drugs based on their potential for abuse: schedules I-IV

1972: Drug Listing Act

Requires registered drug establishments to provide the FDA with a current list of all drugs intended for commercial distribution.

1976: Medical Device Amendment

Requires pre-market approval for safety and effectiveness of medical devices by the FDA.

1983: Orphan Drug Act

Expedited development of orphan drugs for rare diseases.

1984: Drug price Competition and Patent-term restoration Act (Hatch-Waxman Amendment)

Created the modern generic drug industry, by streamlining approval process of generic drugs that are bioequivalent to the Brand-name Drug; Established the Orange book of drugs with therapeutic equivalence.

1987: Prescription Drug Marketing Act (PDMA)

Restricts sale or distribution of free samples and sales of deeply discounted drugs to hospitals.

1990: Omnibus Budget Reconciliation Act (OBRA)

Requires pharmacists to offer counseling to Medicaid patients regarding medications; Established mandatory Drug Utilization Reviews (DUR).

1990: The Anabolic Steroids Control Act

Drugs that contain testosterone are now schedule III and regulated by the Controlled Substance Act.

1994: Dietary Supplement Health and Education Act (DSHEA)

Vitamins, mineral, and herbs are now classified as 'dietary supplements.' Products do not require FDA approval, but FDA can remove them from the market if deemed unsafe.

1996: Health Insurance Portability and Accountability Act (HIPAA)

Safeguard the privacy of protected health information.

1997: FDA Modernization Act

Legend drug requirements must now state: "Rx only"; replaces verbiage of Durham-Humphrey.

2000: Drug Addiction Treatment Act (DATA)

Physicians can prescribe controlled substances to persons suffering from opioid addiction for detoxification.

2003: Medicare Prescription Drug, Improvement, and Modernization Act (MMA or Medicare Modernization Act)

Subsidize the costs of prescription drugs for Medicare beneficiaries (Medicare part D)

2005: The Combat Methamphetamine Epidemic Act (CMEA)

Regulates retail over-the-counter (OTC) sales of ephedrine and pseudoephedrine. (3.6g per day; 9 g per month)

2007: The Food and Drug Administration Amendments Act (FDAAA)

Shifted the FDA's focus from merely approving new drugs to overseeing the safety of drugs even after approval. Established REMS.

2013: Drug Supply Chain Security Act (DSCSA)

AKA: "Track and Trace." Enhances FDA's ability to protect consumers from exposure to drugs that are counterfeit, stolen, contaminated, or otherwise harmful. Established online database

The Joint Comission (TJC)

mission is to "continuously improve the safety and quality of care provided to the public"; sets standards and accredits healthcare facilities like hospitals, skilled nursing facilities.

U.S. Dept of Labor Occupational Safety and Health Org (OSHA)

Sets and enforces safety standards in the workplace; provides education, training and outreach

Food and Drug Administration (FDA)

a federal agency responsible for regulating food and drug products sold to the public; oversees clinical drug trials

Drug Enforcement Agency (DEA)

Enforce the controlled substances laws (C-I - C-V) and regulations of the United States; prevention of distribution of illicit drugs

American Association of Pharmacy Technicians (AAPT)

Created code of ethics and detailed responsibilities of the pharmacy technician; protects the pharmacy technician's right to due process

State Board of Pharmacy (BOP)

State agency that oversees practice of pharmacy in a given state and regulates the practice of pharmacy there.

United States Pharmacopeia (USP)

Develops manufacturing standards, purity, strength, packaging, and labeling; **created standards for sterile and non-sterile compounding

Institute for Safe Medication Practices (ISMP)

A nonprofit organization devoted to promoting safe medication use and preventing medication errors through research and making recommendations

Environmental Protection Agency (EPA)

Federal agency that protects human and environmental health. Created a P-list of hazardous drugs and regulations for safe disposal.