Save
Busy. Please wait.
Log in with Clever
or
show password
Forgot Password?
Don't have an account?  Sign up 
Sign up using Clever
or
Username is available taken
show password


Make sure to remember your password. If you forget it there is no way for StudyStack to send you a reset link. You would need to create a new account. Your email address is only used to allow you to reset your password. See our Privacy Policy and Terms of Service.

Already a StudyStack user? Log In

Reset Password
Enter the associated with your account, and we'll email you a link to reset your password.
focusNode
Didn't know it?
click below
 
Knew it?
click below
Don't Know
Remaining cards (0)
Know
0:00
edit
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.

  Normal Size     Small Size show me how

GGR 10-1-25 Chapter2

Chapter 2: Pharmacy Law, Ethics, and Regulatory Agencies (Focus on Laws)

TermDefinition
Pure Food and Drug Act of 1906 (Wiley Act) One of the first laws enacted to stop the sale of inaccurately labeled drugs. Gave FDA power to prohibit the interstate transport of unlawful food and drugs. Drugs had to met the standards of strength, quality, and purity established by the USP.
Harrison Narcotics Act of 1914 This act required practitioner registration, documentation regarding dispensing and placed restrictions on the importation, sale and distribution of opium, coca leaves and any derivative products.
Federal Food, Drug and Cosmetic Act of 1938 This act granted legal status to FDA, and defined adulteration and misbranding as illegal. This act required package inserts and directions to the consumer regarding safe use.
Durham-Humphrey Amendment of 1951 This law added more instructions for drug companies and made the initial distinction between legend drugs and OTC medications. It required the labeling "Caution: Federal law prohibits dispensing without a prescription."
Kefauver-Harris Amendments of 1962 This law ensures the safety and effectiveness of all new drugs on the U.S. market. It gave the FDA specific authority to approve a manufacturer's marketing application before a drug could be made available for commercial use.
Controlled Substance Act of 1970 Under this act the DEA was formed to enforce the laws concerning controlled substances. A five-level stair-step schedule of controlled substances was introduced based on the drugs intended medical use and abuse potential.
Poison Prevention Packaging Act of 1970 This act requires childproof caps for all OTC and legend drugs with certain exceptions. Exemptions to this act include: physician or patient requests non-childproof caps; for hospitalized patients; or for certain legend medications.
Drug Listing Act of 1972 Mandated the use of the NDC for both prescription and insulin drugs. A drug is not included in the NDC directory until the manufacturer has complied with all FDA requirements.
Orphan Drug Act of 1983 This act encouraged drug companies to develop drugs for rare diseases that affected fewer than 200,000 people. Incentives include providing research grants, waiving lengthy testing requirements.
Prescription Drug Marketing Act of 1987 The intent of this act is to prevent counterfeit drugs and to limit diversion of pharmaceutical samples and prescription drugs
Omnibus Budget Reconciliation Act of 1990 This act changed reimbursement limits and outlines specifics for pharmacies to participate in the Medicaid Drug Rebate Program.
Health Insurance Portability and Accountability Act of 1996 Federal act that protects patients rights, establishes national standards for electronic health care communication, and ensures the security and privacy of health data
Drug Addiction Treatment Act of 2000 This act permits physicians to prescribe DEA approved controlled substances (C-III, C-IV or C-V) for maintenance or detoxification treatments of opioid addiction.
Medicare Modernization Act of 2003 The act, administered under the Medicare Advantage program, provides a drug discount card to beneficiaries with low incomes who require drug company assistance to obtain medications
Combat Methamphetamine Epidemic Act of 2005 This act changed the status of pseudoephedrine (PSE) from OTC to BTC. Only a licensed pharmacist or technician may dispense, sell or distribute PSE, which must be stored behind the counter or locked in a cabinet.
Patient Protection and Affordable Care Act of 2010 This comprehensive health care reform makes preventive care more accessible and affordable. The law requires health insurance companies to cover all applicants with new minimum standards, including individuals with preexisting conditions.
Drug Quality and Security Act of 2013 This act has two separate acts: The Compounding Quality Act and The Drug Supply Chain Security Act , itgives the FDA greater oversight of bulk pharmaceutical compounding by creating a new class of oursourcing facilities which sell to hospitals in bulk.
Created by: Gnesis G
Popular Pharmacology sets

 

 



Voices

Use these flashcards to help memorize information. Look at the large card and try to recall what is on the other side. Then click the card to flip it. If you knew the answer, click the green Know box. Otherwise, click the red Don't know box.

When you've placed seven or more cards in the Don't know box, click "retry" to try those cards again.

If you've accidentally put the card in the wrong box, just click on the card to take it out of the box.

You can also use your keyboard to move the cards as follows:

If you are logged in to your account, this website will remember which cards you know and don't know so that they are in the same box the next time you log in.

When you need a break, try one of the other activities listed below the flashcards like Matching, Snowman, or Hungry Bug. Although it may feel like you're playing a game, your brain is still making more connections with the information to help you out.

To see how well you know the information, try the Quiz or Test activity.

Pass complete!
"Know" box contains:
Time elapsed:
Retries:
restart all cards