Pharmacy Laws and Federal Acts

• 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.

• 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.

• 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.

• 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.

• 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

• Predecessor agency of the DEA.
• In 1973 the BNDD merged into the DEA.
• DEA (Drug Enforcement Administration)

• 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

• Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions

• 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

· Pre-Clinical (animal) testing.

· Review of of Pre-clinical Trial results.
· Determination of safety to use on humans.
· Authorization to ship across state lines.

· Involves a small number of healthy volunteers (25-100).
· Safely tolerated dosages determined.
· Identification of major side-effects
· Emphasis on safety and maximum tolerated dosages.

· Involves many more volunteers (100-300).
· Emphasis on the drugs effect against what it's designed to treat.
· Effects compared with similar patients receiving different treatments.

· Involves a few more volunteers (300-3000).
· Emphasis on the drugs overall effect.
· Effects compared with patients unknowingly taking placebos
· Study of different populations and different dosages.
· Testing the drug in combination with other drugs.
· Final Phase before presenting to FDA for approval.

· Ongoing/Post approval trials.
· Health-care professionals to report any adverse findings.
· This phase lasts eternally, as long as the drug is on the market.