Pharmacy Laws and Federal Acts
related to Pharmacy Technicians
Pharmacy laws is made at local, state and federal levels.
For the purpose of studying for the PTCB or ExCPT exams it is necessary to know the federal acts and pharmacy law. Outlined below is brief summary of the major acts and amendments.
These laws and acts give authority to the
Pharmacy Regulating Agencies
to protect consumers and prosecute criminals. They also give guidance to the court system in deciding on legal matters and Pharmacy law.
The acts and amendments are listed in chronological order to loosely tell the story of how the current laws we use today were developed.
This is not a comprehensive list, but, major acts that are recommended for pharmacy technicians to be familiar with.
Federal Food and Drug Act of 1906
• Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.
Narcotic Tax Act of 1914
• Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.
Federal Food, Drug and Cosmetic Act of 1938
• Known as FDCA 1938.
• Replaced the Food and Drug act of 1906.
• Provided better clarification about misbranding definitions.
• Provided better clarification about adulteration definitions.
• Gave the FDA authority to require adequate testing of new drugs for safety.
The Durham-Humphrey Amendment of 1951
• Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
The Kefauver-Harris Amendment of 1962
• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate information about side effects
The Bureau of Narcotics and Dangerous Drugs (BNDD)
• Predecessor agency of the DEA.
• In 1973 the BNDD merged into the DEA.
• DEA (Drug Enforcement Administration)
Drug Abuse Prevention / Control Act of 1970
• Also known as the Controlled Substances Act (CSA)
• Completely replaced the Harrison Act.
• Required the use of DEA Numbers
• Required comprehensive record keeping and transaction tracking.
• Enforced by the DEA under the US Dept. of Justice
Poison Prevention Packaging Act of 1970
• Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions
Combat Methamphetamine Epidemic Act (2005)
• Enacted to regulate the OTC sales of pseudoephedrine.
• Identity and address of each purchaser to be kept for two years.
• Daily sales of regulated products not to exceed 3.6 grams.
• 30 day purchase limit not to exceed 9 grams
• 30 day purchase via mail order not to exceed 7.5 grams
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