Amendments and Acts Flashcards
(37 cards)
Controlled Substance Act (1970)
- Combat and control drug abuse
- Controlled substance (any drug with potentia for abuse)
- Created 5 schedules
- All C2 must be ordered with DEA222
- All destruction should be done with DEA 41
21st Century Cures Act
Federal Funding for rare diseases
Drug Quality and Security Act (2013)
**Response to meningitis outbreak (60 dead) by contaminated drugs.
Title I: Compounding Quality Act
Title II: Track and Trace
–1.) Sterilize Drugs
–2.) Manuf. must provide transaction info to purchases who must provide info to further purchasers.
–3.) Removed uncertainty regarding when a product compound by pharmacy from cGMP labeling, NDA approval process.
- FDA greater oversight of bulk and pharmaceutical compounding and enhance the agencies ability to track drugs through distribution process
Anabolic Steroids Control Act
- Prohibits dispensing of anabolic (CIII) steroids for intents OTHER than disease treatment
Prescription Drug Marketing Act (1987)
-
REQS. STATE LICENSING OF DRUG WHOLESALERS* - Prohibit re-import of drugs into US by anyone besides manuf.
- Created b/c safety and competition
- Prevent hospitals/etc. from reselling pharm purchases to other busineses
- Sales restrictions and recordkeeping for Rx Drug samples
Combat Methamphetamine Act (2005)
Meth. is a highly addictive stimulant from OTC drugs.
- Restricts availability of products used to make such as Pseudoephedrine, Phenylproanolamine, Ephedrine
- *Products should be stored behind counter and purchase should be recorded
Durham-Humphrey Amendment (1951)
TWO Classes of Drug (OTC and RX).
- Adequate instructions for use
- RX REFILLS and Oral (Phone) Rx’s
- *“Caution: Fed law probihibits dispensing without a prescription”
OBRA (1990)
Req. state standards of drug practice for utilization.
Must ask patient if they have any questions for pharmacist
Food & Drug Administration Modernization Act (1997)
[FDAMA]
- Passed to update labeling on prescription medications
- Expedited availability of safe and effective drugs
- Eliminate Backlog in approval process.
- Fast track drugs for serious or life threatening
- Expand FDA authority over OTC and establishes ingredient labeling for INACTIVE ingredients
- Streamline FDA policies
- Databank of info
- Authority expansion FDA over OTC.
- **INACTIVE INGRED. Labeling
- *Mandates priority for break through tech. in Med Devices.
FDA Amendment Act (2007) [FDAAA]
[(VIOXX)]
-Post market studies for REMS (Risk Eval. n Mitigation Studies)
-Reauthorized/amended many drug and med device provisions set to expire.
-Broader use of PDUFA fees.
Drug safety, labeling, clinical trial data reports and registries.
CMA Limits?
2 YEAR LOGBOOK (Daily = max 3.6g) (Max per person = 9g/30 days) (Kiosk = 7.5g/30 days) (1 tablet = 30 grams)
More than 60mg=
Product name, Quantity sold, Names/address of purchaser, Dates of sale, ID and sign logbook.
Food Additives Amendment (1958)
- Components added to food receive premarket approval for safety.
- *DelaneyClause – anticancer provision prohibits approval of any food additive that cause cancere
FDA Safety and Innovation Act (2012) [FDASIA]
- Collect user fees from industry to fund reviews of innovative drugs, med. devices, generic drugs, and BIOSIMILARS.
- Promote innovation to speed patient access to safe and effective drugs.
- Reduce counterfeiting, block import of adulterated, detect/reduce drug shortages.
- Increase stakeholder involvement in FDA process. Enhance the safety of drug supply chain.
- FDA CAN INSPECT FOREIGN DRUG MANUFACTURERS.*
Medicare Prescription Drug, Improvement, & Modernization Act of 2003
AKA MED Pt. D
- Provide prescription drug coverage to patients eligible for Medicare
- *Voluntary program
- *Established HSA’s
- Has deductible
- Patients pay premium
- Many plans available
Comprehensive Methamphetamine Act
Place 3 drugs (ephedrine, pseudoephedrine and phenylpropanolamine) [EPP] into restriction to prevent meth synthesis.
Prescription Drug User Fee Act (1992)
[PDUFA]
- Required manufs. to pay fees for apps and supplements when the FDA must review clinical studies
- *Fees provide the FDA with resources to hire more reviewers to assess these clinical studies and hopefully speed up NDA reviews
Drug Listing Act (1972)
FDA authority to compile list of currently marketed drugs
- Each drug is given a unique 11 digit NDC
Pure Food and Drug Act (1906)
- Basis on regulation of product, not premarket apprv.
* Prohibited Adulteration and Misbranding of food and drugs interstate commerce.
Chemical Diversion and Trafficking Act
- (20) chemical and the tableting/encapsulating machines known for use in illegal manuf. of controlled substances under FED CONTROL. (e.g. Acetone, Benzyl chloride, ethyl ether, toluene, ephedrine)
Reauthorization Act (2017)
Authorized the user fee programs and enhanced the goals of the Cures Act and created a new category of OTC Hearing Aids
Affordable Care Act (2010)
- Medicare advantage rograms 85% rule
- Atleast 85% of revenue must be spent on patient, other 15% may be spent on overhead cost, plan, admin
- Designed for people w/o healthcare
- No denial of insurance for pre-excisting conds.
- No lifetime limits
- Young adults stay on parents insurance until 26
Orphan Drug Act (1983)
- Congress pass to provide tax and exclusive licensing incentives to manus. to develop and market drugs/biologicals for treatment of rare disease or conditions (<200,000 AMERICANS)
- 7 year license
Dietary Suppl. & Education Act (1994)
Act provided definitions and guidelines on diet supps.
- FDA may remove unsafe supps.
- “This product is not meant to diagnose, cure, treat etc”
- FDA does regulates Diet Supps. as foods than drugs
Kefauver-Harris (1962)
NDA
*ALSO Drug Efficiency Amendment
*Strengthen drug approval process (safe AND Efficacious)
-Retroactive to all drugs between 1938-1962
-Transfered from FTC to FDA powers.
GMP requirements.
-Controls for clinical investigations (consent and reporting of adverse reactions)
