Pharm Acts

Dietary Supplement Health and Education Act (DSHEA)-

•Herbal products are now regulated.

Federal Food, Drug and Cosmetic Act.

Requires the supplement industry to report all serious dietary supplement-related adverse drug effects to the FDA

2007 FDA regulations

•Requires supplement manufacturers to test for purity and to ensure that their products do not contain contaminants.

•They must also verify that the contents within the package match the labeling information.

2011 FDA Food Safety and Modernization Act of 2010.

•provides the FDA with mandatory recall authority for all foods, including dietary supplements, expands facility registration obligations, and requires the FDA to issue new dietary ingredients’ guidance.

1984: Drug Price Competition and Patent Term Restoration Act

•The FDA requires the active ingredient of the generic product to enter the bloodstream at the same rate as the trade name product. They must be biologically and therapeutically equivalent to the trade name before it can be marketed.

•Harrison Narcotic Act

•1914: Established regulations governing the use of opium, opiates, and cocaine , and require registration of all practitioners prescribing narcotics.

•1937: Marijuana laws added

•Food and Drug Administration (FDA)

•Grants approval for drugs marketed in the U.S.

•Sets standards for quality control in drug manufacturing plants

•Determines which drugs can be sold by prescription and over the counter

•Regulates the labeling and advertising of prescription drugs

•Federal Trade Commission (FTC)

•Regulates the trade practices of drug companies

•Prohibits the false advertising of foods, nonprescription (OTC) drugs, and cosmetics

•Omnibus Budget Reconciliation Act of 1990 (OBRA)

•Pharmacists must provide patient counseling and a prospective drug utilization review (DUR) for Medicaid patients

•Food and Drug Act of 1906

•The first federal law to regulate interstate commerce in drugs

•Food, Drug and Cosmetic Act of 1938

•It prohibits interstate commerce of drugs that have not been shown to be safe and effective.

•Durham-Humphrey Law of 1952

•requires certain types of drugs be sold by prescription only and be labeled as “Caution: Federal law prohibits dispensing without prescription”; it also prohibits the refilling of a prescription without directions.

•Drug Amendments of 1962, or the Kefauver-Harris Bill

•mandates that manufacturers demonstrate the effectiveness of drugs, follow strict rules in testing, and submit reports of adverse effects of drugs already on the market. Manufacturers are also required to list generic names in labeling and advertising. Advertising also should state adverse effects, contraindications, and efficacy of a drug.

•Drug Abuse Control Amendments of 1965

require accounting for drugs with a potential for abuse

•Controlled Substance Act of 1970

•replaced the Harrison Narcotic Act and the Drug Abuse Control Amendments to the Food, Drug and Cosmetic Act.

•It sets current requirements for writing prescriptions.