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The Pure Food and Drug Act
A United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines. -
The Food, Drug, and Cosmetic Act
defined the act labeling for products and defined miss branding and adulteration as being illegal -
Durham-Humphrey Amendment
It made a distinction between prescription and over the counter drugs. It established Rx legend (prescription) and OTC (over the counter). -
Kefauver-Harris Amendment
The purpose for it was to make sure that all new drugs marketed in the US must be safe and effective, regulates drug advertising and establish good manufacturing practices. -
Controlled Substances Act
Established the Drug Enforcement Agency, as part of the Department of Justice. Distribution is only permitted between entities registered with the DEA. -
The Poison Prevention Packaging Act
The purpose of the PPPA is prevention of poisoning, especially in children under 5 years old. -
Occupational Safety and Health Act
The identification, evaluation, and control of hazards associated with the work environment. It help protect employees from workplace injuries. -
Drug Listing Act
This act assigns a unique and permanent drug code to each medication. The codes is knows a the National Drug Code (NDC), provides the Manufacture, Product and Strength and Container Size -
Orphan Drug Act
Provides tax financial incentives to the organization that developed and marketed the medication that were not previously available in the United States. -
Prescription Drug Marketing Act
Amends FDCA to require states to license wholesale distributors of prescription drugs. It prohibited the sale and distribution of samples to anyone other than those licensed to prescribe them. -
The Omnibus Budget Reconciliation Act (OBRA)
Is a federal law that establishes regulations for nursing facilities and nurse aide training facilities. -
Dietary Supplement Health and Education Act (DSHEA)
Cannot make false claims on products.
Message FDA has not investigated product.
Product must be identified as dietary supplement.
Ingredient (botanical in origin, part of plant) and strength. Must have proper labeling. -
The Health Insurance Portability and Accountability Act (HIPAA)
A federal law that applies directly to providers, health plans, and clearinghouses (of confidential health information); composed of 5 titles. -
Medicare Prescription Drug Improvement and Modernization Act of 2003
It requires that these individuals receive their prescription drug coverage through Medicare, not their state's Medicaid program. -
Anabolic Steroid Control Act
Changed the definition of anabolic steroids by eliminating the need to prove muscle growth, increasing the number of anabolic steroids to 59. Ensured proper registration, security, labeling, packaging, inventory, record maintenance, disposal, import and export, and criminal liability in connection with anabolic steroids -
Combat Methamphetamine Epidemic Act
Created a category of controlled substances known as "scheduled listed chemical products", including pseudoephedrine, ephedrine, phenylpropanolamine. Products with these ingredients are subject to sales restrictions, storage requirements, and monitored book-keeping. Purchase limitations or 3.6 g/day and 9.0 g/month.
