Federal Part 2 Flashcards
What is the food and rug act 1908?
Food and drugs labels should not be:
* False or misleading
* Adulterated or misbranded
What are the short comings of the Wiley act?
- Did not prevent false or misleading efficacy claims
- Failed to regulate cosmetics and devices
Provided that no new drug could be marketed until proven safe and approved by the new FDA
Food, Drug and Cosmetic Act of 1938
What is adulteration
- filthy, putrid, or decomposed substance
- prepared, packed, or held under unsanitary conditions
- Bad manufactering practice
- Container is poisonous
- Color additives are unsafe
- Unrecognizable label
- Substitutions in active drug
What is misbranding?
- Label is false or misleading
- Imporper pckaging
- Lack of required info for packaging
What created The first time that a clear distinction was made between OTC and prescription drugs?
Durham-Humphrey Amendment of 1951
What are the 3 conditions that should be on Rx drug?
- Habit forming
- Unsafe -> toxicity
- Limited Rx use under a manufacturer’s NDA
Another name for Rx drugs?
Legend drugs: needs script to dispense
What did kefauver-harris accomplish?
- Approval for safety and efficacy
- Evidence of effectiveness
- Post-market requires reports of serious ADRs
- Infomred consent for clinical trials
- Current good manufacturing practices
- Oversight to regulate ads f Rx drugs
What agency regulates the advertising of OTC drugs?
FTC
Jurisdiction of DESI?
Drugs marketed fter 1938
Established the regulations surrounding controlled substances that all manufacturers, importers, exporters, distributors, researchers, hospitals, pharmacies, prescribers and pharmacists must follow
Controlled Substances Act of 1970
How enforces PPPA?
Consumer product safety commission
What did the PPPA achieve
Requires a number of household substances and drugs to be packaged in child-resistant packaging
Amended the FDAC to require all drugs to be registered with the FDA
Drug Listing Act of 1972
Describe the NDC code?
First 4-5 digits: labeler code
Second 3-4 digits: Porduct code
Thrid 1-2 digit: Package code
What is Federal Anti-Tampering Act of 1982?
1.Federal crime to tamper OTC
2.Products require tamper resistant feautres
How long is the exclusivity of an orphan drug?
7 years with incentives and tax credit
What is an orphan drug?
- Dx affects <200,000 people
- No reasonable expectation that the sales revenue will recover the cost of research and development
What are requires initiated by Hatch-waxman?
- Proof of safetyand efficacy are not required for generics
- Only required proof of bioequivalence and proof of acceptable manufacturing methods
- Brand name drug manufacturers given exclusivity as incentive
Patients cannot buy drugs in other countries and bring them into the US, except under these conditions
Prescription Drug markting act
- <90 day supply
- An effective tx is not available in the US
Requires pharmacists to perform a prospective drug utilization review (DUR) and counseling for all Medicaid beneficiaries before dispensing the prescription to the patient
Omnibus
Enacted to reduce public health risks from adulterated, misbranded, counterfeit or expired drugs
Prescription Drug Marketing Act of 1987
According to Omnibus, states are required to implement?
Retrospective DUR for patterns of fraud, abuse, overuse, and medically unnecessary care
Allowed FDA to hire extra reviewers
Prescription Drug User Fee Act (PDUFA) of 1992
Established regulations for dietary supplements that were different from those for drugs or conventional foods
DSHEA
Differentiate drug from supplement?
Drug: claims to cure, prevent, and teat dx
Supplement: address a nutrient deficiency to support health
Protects individuals’ medical records and personal health information (PHI) held by covered entities, such as healthcare providers, health plans, and healthcare clearinghouses
HIPAA
Required the establishment of a registry for clinical trials
FDA Modernization Act of 1997(FDAMA)
What simplified D-humphrey?
FDAMA
* Rx only
* Warning: may be habit forming
Permitted physicians to prescribe and dispense controlled substances in an office-based setting to treat opioid dependence
The Drug Addiction Treatment Act of 2000(DATA 2000)
Can NPs and PAs prescribe controls?
Yes, under the CARA
Medicare Prescription Drug Improvement and Modernization Act of 2003
Created Medicare Part D to cover Rx drugs
Estblished REMS?
FDA Amendments Act of 2007(FDAAA)
Set up a marketplace where individuals and small businesses can compare and purchase health insurance plans and offers subsidies to lower-income individuals to make insurance more affordable
Affordable Care Act of 2010
Created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved product
The Biologics Price Competition and Innovation Act of 2009
Gave the FDA increased authority to regulate compounding
Drug Quality and Security Act of 2013
What is a traditional compounder?
Compound for an individual patient based on a prescription
What is an outsourcing facility?
Typically make larger batches of sterile compounds that are distributed to hospitals and other facilities
Requirements of outsourcing pahrmacies?
- CGMP requemnts
- Under the supervision of licensed pharmacist
- Inspected by FDA
- No Rx requirements
Changed the drug labeling requirements for pregnancy and nursing
Pregnancy and Lactation Labeling Final Rule 2014
What are the new classes of pregnancy and lactation labeling?
- Pregnancy
- Lactation
- Females and males of reporductive potential
An amendment to the Controlled Substances Act:
* Authorized prevention and education
* MAT and anloxone programs
The Comprehensive Addiction and Recover Act (CARA)
Permits pharmacist to partially fill CII prescriptions subject to state law
CARA
