Federal Regulation of the Pharmaceutical Industry- Exam 1 Flashcards
1
Q
******FDCA
A
Food, Drug, and Cosmetic Act
1
Q
******FDCA ADULTERATED
A
- A drug or device is adulterated if:
- it consists of any filthy, putrid, or docomposed substance
- it has been prepared, packaged, or held under unsanitary conditions where it may have become contaminated
- its container is composed of any poisonous or deleterious substance
- it has an unsafe color additive
- its quality or strength has been reduced by the addition or substitution of other substances
2
Q
******FDCA History Continued
A
-
1938: Federal Food, Drug, and Cosmetic Act (FDCA)
- prompted by 107 deaths from sulfanilamide elixir, which was mixed w/ diethylene glycol (antifreeze)
- new drugs must be proven to be safe (to the FDA)
- pre-1938 drugs exempted from “safety” requirement (eg. ASA, warfarin)
3
Q
******FDCA MISBRANDED
A
- A drug or device is misbranded if:
- its labeling is false or misleading
- its labeling is inadequate
- it fails to have required statements prominently displayed & easily understood
- its container is misleading
- the manufacturer/distributor has not included the following in all labeling, descriptive matter, and advertising
- generic name, formula with each ingredient and quantity, information on effectiveness, side effects and contraindications
4
Q
******FDCA- What is a “Drug”?
A
-
DRUG means:
- articles recognized in the US Pharmacopeia. Homeopathic Pharm. or National Formulary
- articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
- articles intended to affect the structure or any function of the body of man or other animals
- articles intended for use as a component of one of the above 3 categories
- no differentiation between Rx and OTC
- manufacturer’s intent= whether an article is a drug
5
Q
*****FDCA Compounding
A
-
Compounding
- State board regulated
- prepared for 1 patient
- immediate demand
- [advertising of drug = ok] (Freedom of Speech issue)
- exempt from NDA and current GMP
- traditional pharmacy function
6
Q
*****FDCA History
A
-
1906: Pure Food & Drug Act
- prompted by unsanitary practices in food & drug industries
- prohibited adulteration and misbranding of foods & drugs
- amended in 1912 to prohibit false & fradulent efficacy claims
7
Q
*****FDCA Manufacturing
A
-
Manufacturing
- FDA inspected and regulated
- resale to 3rd parties
- future demands
- make inordinate amounts
- distribute out-of-state
- sell wholesale
8
Q
****FDCA History- 1962
A
-
1962: Kefauver-Harris Amendments
- prompted by the “thalidomide disaster”: European antinauseants, which caused 1000’s of birth defects
- drugs must be proven to be EFFECTIVE
- retroactive to drugs approved since 1938
- established Good Manufacturing Practices (GMP)
- required “informed consent” of research subjects in investigational drug trials
9
Q
****FDCA History Continued
A
-
1951: Durham-Humphrey Amendments
- established 2 classes of drugs:
- prescription (Rx)
- over-the-counter (OTC)
- authorized ORAL prescriptions and refills
- established 2 classes of drugs:
10
Q
****FDCA- Prohibited Acts
A
- Most prohibited acts involve misbranding or adulteration
- Violation of FDCA is subject to strict liability
- Applicable to pharmacies
- The mere receipt and subsequent delivery of an adulterated or misbranded drug
- The doing of any act which causes a drug to be counterfeit
- The alteration, mutilation, etc. of the labeling
11
Q
****FDCA- Rx Label Requirements
A
A prescription label MUST contain:
- Name and address of the pharmacy
- Serial number of the prescription
- Date of the prescription filling
- Name of the prescriber
- Name of the patient
- Directions for use
- Cautionary statements if indicated on the prescription
12
Q
****NDA Process- Phase IV Studies
A
-
Phase IV Studies
- FDAAA empowered FDA to require manufacturers to conduct Phase IV studies when adverse event reporting or active surveillance is inadequate
13
Q
****New Drug Application Process- Post Marketing Surveillance
A
-
Post Marketing Surveillance
- Required of manufacturer after NDA approval
- Must submit to FDA reports of serious adverse drug reactions and any new information of safety and efficacy
14
Q
****Out-of-State Rx
A
- Usually Rx from other states is honored as a professional courtesy
- Usually illegal to fill a Rx from a foreign country
- Texas allows written Rx for non-controlled medications from Canada and Mexico
15
Q
****Rationale for Federal Drug Regulation
A
- Protection of the public against adulterated and misbranded drug products
- Necessity of balancing “direct regulation” and “indirect regulation”
15
Q
***Drug Price Competition (DPC) & Patent Term Restoration Act (PTRA) of 1984
A
- Expedited generic approval process
- Generic manufacturer must demonstrate:
- same active generic ingredient
- bioequivalence
- acceptable manufacturing and control
- Concessions to innovator drug companies included
- patent extensions
- market exclusivity