Sherman Antitrust Act - correct answer This act:
Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen
... [Show More] competition
Federal Food Drug and Cosmetic Act - correct answer This act states:
No adulterated or misbranded drugs in interstate commerce
Adulteration - correct answer Gross - Think inside the capsule
Misbranded - correct answer Improperly labeled - think outside the bottle
FDCA - correct answer This act requires:
ingredients are disclosed on bottle
drug must be proven safe before marketing
authorizes FDA inspection of manufactures and distributors
Public Health Service Act - correct answer This act:
- biologic drugs approved under BLA not NDA
- reviewed for purity, potency, and safety
Durham- Humphrey Labeling Amendments to FDCA - correct answer This act:
- allows for refills
- establishes Rx and OTC
OTC requirements of Durham-Humphrey - correct answer This act states:
- must be labeled with adequate directions for use (drug facts label)
- pregnancy/ breast feeding warning
- domestic contact information to receive ADR report
- OTC drugs approved under OTC monograph or NDA
Rx requirements of Durham-Humphrey - correct answer This act states:
- Rx must be labeled with adequate info for use (package insert)
- Rx approved under NDA - grandfathered pre 1938
Durham-Humphrey Act established Pregnancy Categories
What are they? - correct answer A - safe in humans
B - safe in animals - no data in humans
C - Unknown safety in humans
D - unsafe in humans - benefits may outweigh risks
X - unsafe in humans - risks always outweighs benefits
Unit Dose Drugs - Labeling requirements - correct answer These items are required on which labels?
- generic name or brand - not both
- strength
- dosage form
- exp date (1 yr or earlier if manufacturer is sooner)
- Lot number
- business name of packager
- qty
-Rx only + Cautionary statement (if applies)
** directions for use are not required on dose but should be stored where can be accessed easily
Kefauver-Harris Drug Efficacy Amendments to FDCA - correct answer This act states:
- drugs must be proven effective before marketing
- creates NDA and SNDA
Phase I, II, and III research - studies require informed
consent and IRB approval
- IND required to test new drugs in humans (FDA has 30 days to issues "clinical hold" or else study can proceed
- mandates informed consent in clinical research
- ADRs must be reported to FDA on Med Watch Form
Manufacturers are required to report ADRs
Healthcare professionals and patients are voluntary
- All drug labels must have brand and generic name
- Advertising FDA for Rx FTC for OTC
- Establishes cGMP - current good manufacturing practices
- Manufacturers must register facility and be inspected every 2 years
- If not registered - drugs are Misbranded
- If a facility produces substandards of strength, quality or purity drugs are adulterated
Advertising of Rx drugs is by - correct answer FDA
Advertising of OTC drugs is by - correct answer FTC
ADRs must be reported on which form - correct answer Med Watch Form
If a Manufacturer is not registered the drugs are considered - correct answer Misbranded
If a facility produces substandards of strength, quality, or purity drugs are considered _________? - correct answer Adulterated
Pharmacies that compound large amounts of drug not based on an individual's Rx must register with the FDA as a _____________? - correct answer Manufacturer and meet cGMP
Poison Prevention Packaging Act - correct answer This act states:
- Pharmacy must dispense drugs using Child-resistant containers (exceptions: sl nitro, chloestyramine, erthyromycin, prednisone)
- may use reversible caps
- cannot reuse containers
- Patient may make a blanket request for non child resistant containers (verbal request is ok)
- Physician may request an individual Rx be non child resistant but cannot make a blanket request
- Hospitals are exempt
- Manufacturers may market one size as non child resistant
Identify some drugs that are exempt from PPPA - correct answer - sl nitro
- chloestyramine
- erythromycin
- prednisone
Who may make a blanket request from non child resistant containers? - correct answer Patient - may give verbal auth
Can a physician give a blanket approval for non child resistant containers for a patient? - correct answer No
May however give auth for an individual Rx
Federal Anti-Tampering Act - correct answer This act stipulates that OTC products must be in tamper resistant packaging
Orphan Drug Act - correct answer This act gives incentives to companies to create drugs for rare diseases - must still submit an NDA
Federal False Claims Act - correct answer This act stipulates that you are not allowed to falsely bill Medicaid or Medicare. Whistleblowers are allowed 25%
Hatch Waxman Amendment to FDCA - correct answer This act is also known as Drug Price Competition and Patent-Term Restoration Act [Show Less]