-
The Pure Food & 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. -
The food drug and cosmetic act
- 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.
-
Durham - Humphrey Amendment
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. -
kefauver - Harris 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
-
Controlled substances Act
- 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
-
The poison prevention packaging act
known as the PPPA
- Designed to reduce the risk of children ingesting dangerous substances.
- Required locking caps on most prescriptions -
Occupational safety and health act
imposes a duty to employers to provide their employees with a workplace and job free from recognized hazards that may cause death or serious physical harm Requires employers to inform employees who could be exposed to hazardous chemicals provide employees with training so that they can effectively protect themselves -
Drug listing act
1972, the Drug Listing Act assigns a unique and permanent drug code for each medication. The codes are known as a National Drug Code (NDC), provides the Manufacture, Product and Strength and Container Size Gives FDA authority to compile a list of currently marketed drugs.
*Each drug is given a unique 11 digit National Drug Code (NDC) -
Orphan Drug Act
1983, financial incentives to organization that develop and market medication that were not previously available in the United States.
Development of Orphan Drugs to continue affects < 200,000 people in the US at a point in time or affects > 200,000 people but there is no reasonable expectation that the sales would exceed the drug's development costs -
Prescription Drug marketing act
Ammends FDCA to require states to license wholesale distributors of prescription drugs. What does the act ban? Re-importation of prescription drugs except by manufacturer or for emergency use.Trafficking in or counterfeiting of drug coupons. Waht did the act ask for? Minimum storage, handling and recordkeeping requirements for drug samples -
The Omnibus Budget Reconciliation Act (OBRA)
(1987) is a federal law that establishes regulations for nursing facilities and nurse aide training facilities. The intent was to improve the quality of life residents in nursing facilities. Primarily focus on Resident rights, restorative care, Psychosocial care and preventive care to maintain maximum physical and mental wellness of residents. regultions focus on State inspection of facilities for compliance with regulations with penalties for noncompliance. -
Dietary Supplement Health and Education Act (DSHEA)
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. -
The Health insurance portability and Accountability Act (HIPAA)
covers Administrative physical technical. Measures, policies, and procedures to protect electronic information systems from natural and environmental hazards, as well as unauthorized intrusion.there is 4 levels of HiPPA violations -
Medicare prescription drug improvement and modernization act
Legislation that enacted the most sweeping changes to Medicare since its inception by affording Medicare beneficiaries a prescription drug benefit. Starting in 2006, individuals who are eligible for Medicare Part A or enrolled in Medicare Part B were eligible to participate in the program, which provides a voluntary drug benefit for beneficiaries through private companies. -
Anabolic Steroid control act
Changed the definition of anabolic steroids by eliminating the need to prove muscle growth, increasing the number of anabolic steroids to 59. Ensured proper registration, security, labeling, packaging, inventory, record maintenance, disposal, import and export, and criminal liability in connection with anabolic steroids -
Combat Methamphetamine Epidemic Act
- 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
