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This act limits the transport of opium. In order to purchase opium, a prescription is required
1914 Harrison Narcotic Act
This act prohibits the sale of adulterated or mislabeled food, drinks and drugs
1906 Federal Food and Drug Act
This act made the Food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal.
*provide package inserts
* Labeled "habit forming" if case
* has to be proven safe according to FDA to be marketed
1938 Food Drug and Cosmetic Act
This act distinguishes legend drugs from OTC.
*labeled "federal law prohibits dispensing w/o a prescription
* physician supervision for the purchase of legend drugs
* OTC has to have specifics on label
1951 Durham Humphrey Amendment
According to the Durham Humphrey Amendment what has to be on OTC labels?
- *Product name
- *Name and address of manufacturer and/or distributor
- *Active ingredients
- *Quantities of all other ingredients whether active or not
What amendment was enacted due to birth defects caused by the drug thalidomide in Europe?
1962 Kefauver-Harris Amendment
This Amendment requires all drugs to be proven safe and effective
Stricter requirements are now placed on drug manufacturers seeking drug approval
FTC not the FDA, now handles drug advertisement
Manufacturer must register annually, report any adverse reactions, and be inspected every 2 years
1962 Kefauver-Harris Amendment
Act that which DEA was formed from and is charge of scheduling controlled substances based on abuse potential. I the highest, V the lowest
1970 Comprehensive Drug Abuse Prevention and Control Act
This act requires childproof packaging on most drugs dispensed in a pharmacy
1970 Poison Prevention Packaging Act
This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases. These drugs are made for such a small percentage of the population that the drugs demand does not make marketing and maufacturing in large quantities economically feasible
1983 Orphan Drug Act
This act established the FDA as an agency of the Department of Health and Human Services. Also, in 1988 the Prescription Drug Marketing Act was established, which banned the sale, trade or purchase of drug samples.
1988 Food and Drug Administration Act
What organization do you report any adverse drug reactions and outcomes?
This act requires a pharmacist to attempt or offer to counsel patients on all new prescriptions. Pharmacists are now required to provide information on any drug being dispensed such as: namen and discription of the medication, and how much of the medication shoulw be take, side effects, contraindication, interaction, ect
1990 Omnibus Budget Reconciliation Act (OBRA)
This act created rules and regulations regarding the privacy and security of patient health information. This act providdes limiations stating who can access, distribute and receive patient health information.
1996 Health Insurance Portability and Accountability Act (HIPAA)
THis act limits the purchase of pseudoephedrine products to 3.6 g of pse per day or 9 g per 30 days
2006 Combat Methamphetamine Epidemic Act (CMEA)