1906: The Pure Food and Drug Act (PFDA)
- Restricted manufacture and scale of drugs and established USP/NF as official standard
- Required all food and drugs to meet a standard of strength and purity.
1907: Wiley Heyburn Act
- Prohibited adulteration and misbranding of food and drugs and required proper labeling of drugs.
1911: The Sherley Amendment to the PFDA
- Prohibited any company from making false therapeutic claims when labeling medicines for the purpose of defrauding the purchaser and put the responsibility of proving fraud on the government.
1914: The Harrison Narcotic Act
- Regulated the importation, sale, manufucture, and use of opium, cocaine, marijuana, many synthetic analgesics, and derivatives that produce or sustain physical or psychologic dependence.
- Established the work "Narcotic" as a legal term
1931: The Food and Drug Administration (FDA)
- It was renamed in order to enforce existing drug laws.
1938: The Federal Food, Drug, and Cosmetic Act (FFDCA)
- It was resulted from the "Elixir of Sulfanilamide" tragedies, in which 107 people died from taking elixir of sulfanilamide that contained the toxic solvent ethylene glycol.
- This act required that the following criteria be met.
- Manufacturers of drugs and cosmetics must prove that their products are safe.
- Medical devices must be proven effective.
1938: Amendment to Sherley Act
- It mandated that drug manufacturers test all drug for harmful effects before they enter the market. All drugs including OTC should be properly labeled.
1952: The Durham-Humphrey Amendments to the FFDCA
- It further clarified the distinction between prescription and over-the-counter drugs based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially harmful. These amendments required a physician's consent in order to dispense refills, giving rise to the legend, "Caution: Federal law prohibits dispensing without a prescription."
1962: The Kefauver-Harris Amendments to the FFDCA
- It required drug manufacturers to prove the efficacy of their products before approval was given by the FDA for marketing. These amendments resulted from the thalidomide tragedies in which the sedative thalidomide was used in Europe as an antinauseant for pregnant women, and it caused severe deformities in their offspring. Thalidomide was never approved for use in the United States.
1966: The Drug Efficacy Study Implementation (DESI) review
- It took place when the FDA contracted an outside agency (the National Academy of Sciences/National Research Council) to establish panels of scientists in order to examine the efficacy of all drugs that were manufactured between 1938 and 1962. Approximately 4000 of these drugs were then rated as effective, probably effective, possibly effective, or ineffective.
Significant Federal Drug Laws: 1970 to 1991. Many of the laws and regulation that pharmacists must follow are partly due to amendments of the FFDCA of 1938.
1970: Controlled Substances Act (CSA)
- The CSA is Title II of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention And Control Act of 1970, which was enacted to improve the administration and regulation of all parties involved with the manufacturing, distribution and dispensing of controlled substances.
See the Complete Schedule Here.
See the Complete Schedule Example Here.
1970: Poison Prevention Packaging Act
- It was passed in response to accidental poisonings in children. With certain qualifications, the act generally requires a child-resistant closure on aspirin, acetaminophen, methylsalicylate, controlled substances, iron-containing drugs, diphenhydramine, and most oral prescription drugs.
1972: OTC drug review
- The FDA appointed advisory panels to evaluate approximately 80 therapeutic classes of drugs in order to assure that they are safe and effective for use by the public for self treatment. Ingredients for OTC use were classified in one of three categories:
- Category I - Drugs are safe and effective and not misbranded (i.e. do not include false, misleading, or incomplete labeling).
- Category II - Drugs are not safe and effective, or they are misbranded.
- Category III - The data available are insufficient for classification of these drugs.
- It was enacted in response to the 1982 deliberate contamination of Tylenol R capsules. This act requires the following:
- Tamper-resistant packaging must be used for certain OTC products, cosmetics, and medical devices.
- Packages "must have an indicator or barrier to entry that, when breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred."
- It allows manufacturers to gain incentives for the research, development, and marketing of drug products that are used to treat rare disease or conditions that would otherwise be unprofitable.
1984: The Drug Price Competition and Patent Term Restoration Act (Waxmann-Hatch Amendments to the FFDCA)
- It was enacted to create a fair environment between the pioneer drug manufacturer and the emerging generic drug industry.
- Title I o this act allows generic drug firms to use Abbreviated New Drug Applications (ANDA) to gain quicker FDA approval for their products.
- Title II provides pioneer drug companies with patent extensions for those products that lose marketing time while in the regulatory review process.
- It was enacted to address the problems associated with the diversion of prescription drugs from legitimate commercial channels. This act:
- Requires states to license wholesalers
- Bans the sale, trade, or purchase of drug samples
- Requires that all requests for drug samples by practitioners be made in writing and that records be maintained concerning the receipt and storage of drug samples.
