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

Chapter 2

Acts & Amendments - What they did

OrganizationWhat it did
1906 Pure Food and Drug Act Stop the sale of inaccurately labeled drugs. Manufacturers were required to provide truthful information on the label before a drug was sold, and prove the drug's effectiveness.
1914 Harrison Narcotics Act Made it so opium was no longer available without a prescription. Implemented restrictions on the importation, sale, and distribution of opium, coca leaves, etc. Records and documentation also required for prescriptions.
1938 Federal Food, Drug, and Cosmetic Act Required drug companies to include package inserts and directions to the consumer regarding safe use. Defined misbranding and adulteration as illegal. "Warning: May be habit forming."
1951 Durham-Humphrey Amendment Made the distinction between legend drugs and OTCs. "Caution: Federal law prohibits dispensing without a prescription." Certain drugs require a doctor's order and supervision.
1962 Kefauver-Harris Amendment Safety and effectiveness of all new drugs on the market. "Good manufacturing practice" (GMP). Prevented the sale of thalidomide in the United States.
1970 Comprehensive Drug Abuse Prevention and Control Act Also known as the Controlled Substance Act. Established the Drug Enforcement Administration (DEA) to enforce the laws on controlled substances and their distribution. Created the 5 categories for controlled substances (schedules/classes).
1970 Poison Prevention Packaging Act Required all medications to be filled in containers with childproof caps or packaging. Unless requested otherwise by the physician, patient, or it's a certain kind of legend drug.
1972 Drug Listing Act 10-digit number divided into 3 segments. Numbers identify the labeler, product, and trade package size. First set of numbers being assigned by the FDA, while the next two are created by the manufacturer.
1983 Orphan Drug Act Encouraged manufacturers to develop new drugs for rare diseases (affecting 1 in 200,000 people) by providing research assistance, grants, and cost incentives.
1987 Prescription Drug Marketing Act Helps prevent counterfeit drugs and ingredients from entering the supply chain. Limits diversion of pharmaceutical samples and prescription drugs.
1990 Omnibus Budget Reconciliation Act (OBRA '90) Pharmacists must counsel (at the time of purchase) all Medicaid patients who receive new prescriptions. Requires drug utilization evaluation (DUE) to ensure all prescriptions are appropriate. Started in California.
1996 Health Insurance Portability and Accountability Act (HIPAA) Protects all "individually identifiable health information", and ensures the security and privacy of health data. Established the principle of protected health information (PHI). Establishes national standards for electronic health care communication.
2000 Drug Addiction Treatment Act (DATA 2000) Allows physicians to prescribe controlled substances (CIII - CV) to individuals suffering from opioid addictions. Only for maintenance or detoxification treatments.
2003 Medicare Modernization Act Provides a drug discount card to those with low incomes who require assistance from a pharmacy company to obtain medications. Administered under the Medicare Advantage program (2006). Reduces preventable hospitalization resulting from lack of medication.
2005 Combat Methamphetamine Epidemic Act Passed due to the diversion of pseudoephedrine (PSE). Created strict guidelines for the manufacture, distribution, and sale of PSE. Only licensed pharmacist or technicians may dispense, sell, or distribute the drug.
2010 Patient Protection and Affordable Care Act (ACA) Made preventive care more accessible and affordable for many Americans. Implemented electronic health records (EHR) and medication therapy management (MTM).
2013 Drug Quality and Security Act Gave the FDA tracking systems for bulk compounding supplies. To verify proper manufacturing practices after the fungal meningitis outbreak in 2012 from unsanitary conditions.
1862 FDA Enforces guidelines for manufacturers to ensure safety and effectiveness of medications.
Created by: gfigueroa
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