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SA -- PLAW > Amendments and Acts > Flashcards

Amendments and Acts Flashcards

1
Q

Controlled Substance Act (1970)

A
  • 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
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2
Q

21st Century Cures Act

A

Federal Funding for rare diseases

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3
Q

Drug Quality and Security Act (2013)

A

**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
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4
Q

Anabolic Steroids Control Act

A
  • Prohibits dispensing of anabolic (CIII) steroids for intents OTHER than disease treatment
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5
Q

Prescription Drug Marketing Act (1987)

A
  • 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
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6
Q

Combat Methamphetamine Act (2005)

A

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
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7
Q

Durham-Humphrey Amendment (1951)

A

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”
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8
Q

OBRA (1990)

A

Req. state standards of drug practice for utilization.

Must ask patient if they have any questions for pharmacist

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9
Q

Food & Drug Administration Modernization Act (1997)

[FDAMA]

A
  • 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.
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10
Q

FDA Amendment Act (2007) [FDAAA]

A

[(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.

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11
Q

CMA Limits?

A 
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.

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12
Q

Food Additives Amendment (1958)

A
  • Components added to food receive premarket approval for safety.
  • *DelaneyClause – anticancer provision prohibits approval of any food additive that cause cancere
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13
Q

FDA Safety and Innovation Act (2012) [FDASIA]

A
  • 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.*
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14
Q

Medicare Prescription Drug, Improvement, & Modernization Act of 2003

A

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
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15
Q

Comprehensive Methamphetamine Act

A

Place 3 drugs (ephedrine, pseudoephedrine and phenylpropanolamine) [EPP] into restriction to prevent meth synthesis.

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16
Q

Prescription Drug User Fee Act (1992)

[PDUFA]

A
  • 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
17
Q

Drug Listing Act (1972)

A

FDA authority to compile list of currently marketed drugs

- Each drug is given a unique 11 digit NDC

18
Q

Pure Food and Drug Act (1906)

A
  • Basis on regulation of product, not premarket apprv.

* Prohibited Adulteration and Misbranding of food and drugs interstate commerce.

19
Q

Chemical Diversion and Trafficking Act

A
  • (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)
20
Q

Reauthorization Act (2017)

A

Authorized the user fee programs and enhanced the goals of the Cures Act and created a new category of OTC Hearing Aids

21
Q

Affordable Care Act (2010)

A
  • 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
22
Q

Orphan Drug Act (1983)

A
  • 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
23
Q

Dietary Suppl. & Education Act (1994)

A

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
24
Q

Kefauver-Harris (1962)

A

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)

25
Q

Color Additives Amendments (1960)

A
  • Requires manus. to establish safety of color additives in food, drugs and cosmetics. FDA can approve a color for one use, but not others (external etc.)
  • Amended to FDCA
26
Q

Anabolic Steroid Act (1990)

A

Wide use of steroid abuse by athletes

  • Synthetic versions of testoserone
  • CLASS 3 drug (side eeffects are serious and permanent)
27
Q

Food and Drug Cosmetic Act (1938)

A
  • Form nucleus of todays’ law.
  • No new drug marketed until proven safe under conditions described.
  • FDA Approval
  • Expanded definitions of adult/misbrand. (REQUIRE labels to contain adequate direction for use and warning about habit form)
28
Q

Drug Price Competit. & Patent Term Restoration Act (1984)

A

(WAXMAN-HATCH Amendment)

  • Act to streamline generic drug approval, while giving patent extensions to innovator drugs
  • Incentives to develop new drugs
    • (A)NDA MUST BE BIOEQUIVALENT
29
Q

Safe Medical Devices Act (1990)

A

Requires reporting of serious injury, illness or death caused by Med. Devices

  • Expedite premarket device approval
  • More authority related to post marketing and premarketing notif. and approval
30
Q

Nutrition Labeling and Education Act (NLEA)

A

Mandates nutrition labeling on food products and AUTHORIZES HEALTH CLAIMS on product labeling.
*As long as made in compliance w/ FDA regs.

31
Q

Medical Device Amendment (1976)

A

~Requires classification (3 most regul./sustaining of life) of devices according to their:

  • Function
  • Premarket approval
  • Performance standards
  • GMP req. conformance, and
  • Adherence to record and reporting of medical devices
32
Q

Health Insurance Portability and Accountability (1996)

A

HIPAA wide range provisions.

  • Employee training program with yearly renewal
  • Confidentiality of patient records
33
Q

Dietary Suppl. & Nonprescription Drug Consumer Prot. (2006)

A
  • Regulate claims on dietary supplement
  • “PRODUCT IS NOT INTENDED TO DIAGNOSE, TREATE, CURE, OR PREVENT ANY DISEASE”
  • Truthful and not misleading
34
Q

Poison Prevention Package Act (1970)

A

Prevent childhood poisoning (Child proof containers)
-Applies to OTC and RX
Excludes: Inhalers, BC and Nitro

35
Q

Generic Drug Enforcement Act

A
  • Result of scandal occurred when FDA staff accepted bribes from generic drug to facilitate approval
  • Law authorizes FDA to ban indiv. or firms from participating in drug approval if convicted of related felonies
  • Severe penalties for false statements, bribes, failures to disclose material facts
36
Q

Controlled Substance Registeration Protection Act

A
  • Robberies, burglaries, violent crimes
  • *Fed Invest. occurs if ONLY ((ONE)) condition is met.
    1. ) Replacement cost for taken controls is $500+
    2. ) Registrant or person is killed/sig. injury
    3. ) interstate or foreign commerce is involved in planning/execution of crime (highway)
37
Q

Harrison Narcotics Act (1914)

A
  • US Gov attempt to limit opium sales

- Opium as RX only

SA -- PLAW (2 decks)

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