📌 Laws containing the "fun fact" emoji (🤯) in their
headersare not ones you have to remember by name.
DEA Policy (🔗 To Document)
| Title | Notes |
|---|---|
| Controlled Substances Act (CSA, 1970) | Classifies drugs into Schedules I–V based on abuse potential and medical use, regulating distribution. |
| Combat Methamphetamine Epidemic Act (CMEA, 2005) | Regulates pseudoephedrine and related substances with sales limits and strict storage requirements. |
Pure Food & Drug Act, FDCA, & Amendments (🔗 To Document)
| Title | Notes |
|---|---|
| Pure Food & Drugs Act (1906) | Prohibited adulterated or misbranded food & drugs in interstate commerce. Required purity standards, truthful labeling, disclosure of dangerous ingredients, and initiated FDA enforcement. |
| Food, Drug, and Cosmetic Act (FDCA, 1938) | Required premarket safety approval of drugs after sulfanilamide deaths. Expanded FDA authority to cosmetics and devices. Required labeling with warnings and directions. |
| Durham-Humphrey Amendment (1951) | Distinguished Rx and OTC drugs. Authorized verbal prescriptions and refills. Required "Rx Only" legend on prescription drugs. |
| Kefauver-Harris Amendment (1962) | Required drug effectiveness proof and FDA pre-approval. Instituted GMP standards and adverse event reporting after thalidomide tragedy. |
| 🤯 Medical Device Amendments (1976) | Classified devices by risk (Class I–III). Required premarket approval for high-risk (Class III) devices after the Dalkon Shield disaster. |
| 🤯 Orphan Drug Act (1983) | Provided incentives (tax credits, market exclusivity, grants) for developing drugs for rare diseases. |
| 🤯 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman, 1984) | Created ANDA pathway for generics. Allowed brand drugmakers to recover patent life lost during FDA approval. Balanced generic entry with brand protection. |
| Prescription Drug Marketing Act (PDMA, 1987) | Prohibited drug reimportation (except by manufacturer), regulated drug sample distribution, and required wholesale distributor licensure. |
| 🤯 Food & Drug Administration Amendments Act (FDAAA, 2007) | Required clinical trial registration and pediatric study requirements. Authorized FDA to mandate REMS programs for certain high-risk drugs (e.g., opioids, biologics). |
| 🤯 Drug Quality and Security Act (DQSA, 2013) | Enhanced oversight of compounded drugs and drug supply chain security. Created "outsourcing facility" category subject to cGMP and FDA inspections. |
Extended Packaging & Labeling Policy (🔗 To Document)
| Title | Notes |
|---|---|
| Fair Packaging & Labeling Act (FPLA, 1967) | Requires clear, truthful labels showing manufacturer info, quantity, and product identity. |
| Drug Listing Act (1972) | Requires drugs to have an 11-digit National Drug Code identifying manufacturer, product, and packaging. |
| 🤯 Drug Supply Chain Security Act (DSCSA, 2013) | Mandates unique product identifiers, 2D barcodes, electronic tracking, and rapid counterfeit reporting. |
Healthcare Policy (🔗 To Document)
| Title | Notes |
|---|---|
| Social Security Act Amendments (1965) | Created Medicare and Medicaid; foundational for public healthcare reimbursement and pharmacy regulations. |
| OBRA-90 (1990) | Requires patient profiles, DURs, and mandatory counseling offers for Medicaid prescriptions. |
| 🤯 Public Health Service Act (PHSA, 1944; 340B in 1992) | Establishes federal public health infrastructure and programs; includes the 340B program allowing eligible providers to purchase discounted outpatient drugs for underserved populations. |
| Medicare Modernization Act (MMA, 2003) | Established Medicare Part D and mandated MTM services to improve outcomes and medication safety. |
HIPAA & Amendments (🔗 To Document)
| Title | Notes |
|---|---|
| HIPAA (1996) | Protects patient privacy by regulating the use, disclosure, and safeguarding of PHI by Covered Entities. |
| 🤯 HITECH Act (2009) | Expands HIPAA to include business associates and promotes secure use of electronic health records. |
Miscellaneous Law (🔗 To Document)
| Title | Notes |
|---|---|
| Occupational Safety & Health Act (OSHA, 1970) | Requires employers to provide PPE, training, and Safety Data Sheets (SDS) for hazardous substances. |
| Red Flag Rule (2007) | Requires pharmacies that bill insurance or offer credit to implement identity theft prevention programs, detect red flags, and train employees accordingly. |
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