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PTCB Laws

Pharmacy Laws and Regulations

Law or RegulationPurposeDates
Federal Food, Drug, and Cosmetic Act (FD&C) Gives FDA oversight of the safety of the food, drug, and cosmetics industries. into effect 1938
Food and Drug Administration (FDA) Formed to oversee the production and safety of food and drugs in the US. formed in 1927
The Joint Commission (TJC) A majority of state governments recognize Joint Commission accreditation as a condition of licensure and the receipt of Medicaid and Medicare reimbursments. Conducts regular inspections of healthcare facilities (incl pharm). 1951
Drug Enforcement Agency (DEA) Enforce laws relating to drug use, according to the Controlled Substances Act. 1973
Controlled Substances Act (CSA) Created 5 Schedules of controlled substances. The DEA and the FDA, determine which substances are added to or removed from the various schedules. 1970
Prescription Drug Marketing Act 1. Ensure all marketed drugs are safe and effective 2. Prevent consumer risk from counterfeit, subpotent, expired, misbranded dugs 1988, modified in 1992
Health Insurance Portability and Accountability Act (HIPAA) Protect patients' medical information from improper distribution. enacted 1996, into effect 2003
Created by: fibro_fog