1906 and 1938
The law that required food or drug label could NOT BE FALSE to misleading and the presence of harmful ingredients (alcohol, heroin, cocaine) had to be listed
What is Pure For and Drug Act of 1906
What is the aim of Durham - Humphrey Amendment if 1951
What is a clear distinction made between prescription and OTC
The party that regulates OTC drugs
What is Federal trade Commission
This act made the tampering of OTC products a federal crime, and required tamper resistant features on OTC medications
What is the Federal Anti-Tampering Act of 1982
This Act help to reduce public health risk form adulterated, misbranded, counterfeit, or expired drugs.
BONUS** What does this law prohibit?
What is Prescription Drug Marketing Act of 1987
BONUS*** What is reimportation
What act required the manufacturer, not the FDA, to prove safety of the drug before it could be marketed.
What is the Food and Drug Cosmetic Act of 1938
The three conditions that make a drug available only by prescription:
What is
1.) Drugs that are habit forming
2.) Drugs considered unsafe for use except under expert supervision due to toxicity concerns
3.) Drugs limited to prescription use only under a manufacturer's new drug application
What Amendment gave way to the FDA to establish current goof manufacturing practices, regulate adverting of prescription drugs, and needed informed contact by individuals participating study subject in clinical trials
What is Kefauver-Harris Amendment of 1962
What is the act that was used to develop drugs used to treat diseases that affect <200,000 people in the US
BONUS: Tell the incentives
What is the Orphan Drug Act of 1983
BONUS: Tax credits for 50% and 7 year period of exclusivity
This act required pharmacist to preform a prospect drug utilization review (DUR) and counseling for all Medicaid beneficiaries before dispensing the prescription to the patient? And what was states also required to Preform
What is Omnibus Budget Reconciliation Act (OBRA) and retrospective drug utilization review
Drugs that are before the 1938 act are ____ in
BONUS POINTS IF CAN GIVE EXAMPLES
Grandfathered in
- Example Nitroglycerin and Digoxin
The Amendment that must prove that a drug is safe and effective before it can be FDA approved
What is Kefauver - Harris Amendment of 1962
What Act enforced the consumer product safety commission, that required a number of household substances and drugs to be packaged in child resistant (CR) packaging
What is Poison Prevention and Packaging Act of 1970 (PPPA)
This is also known as the Drug Proce Competition and Patent Term Restoration Act
What is the Hatch-Waxman Act of 1984
What Act defined dietary supplements as food products.
BONUS: Dietary supplements defintion
What is the Dietary Supplement Health and Education Act of 1994 (DSHEA)
Dietary supplements cannot cure or treat but instead help promote to support body functions
This Act required that no adulterated or misbranded drugs could be sent through interstate commerce
What is the pure food and drug act of 1906
According to the Kefauver-Harris Amendment after a drug is on the Market, manufactures must continue to do this
What is Report serious side effects to the FDA
What is the act that aimed to have each individual drug a unique national drug code (NDC) number
What is the Drug Listing Act of 1972
What is the act that made it to where companies can file ANDA
Hatch- Waxman Act of 1984
The information that must be on a dietary supplement label
What is Descriptive name of the product
The wording supplement
the name and address of the manufacturer/packer/distibutor
A complete list of ingredients and the net contents
What law aimed to regulate interstate commerce
What is Pure Food and Drug Act of 1906
This term describes entering impurities into a drug?
BONUSSSS **** can something be both and what is misbranding
What is Adulterated
The components of the NDC product identifier
10 or 11 digit code with three segments
Laberler code/Manufactuer code (4 or 5 digits) - assigned by FDA
Product code ( 3 or 4 digits) - which identifies strength, dosage, and formulation
Package code ( 1 or 2 digits) - identifies the package size and type
The formulation of a generic drug has to have this to be classified as the same -- better known as bioquivalent
What is The FDA Modernization Act of 1997 (FDAMA)