Pharmacy laws

Question 1

1906 Pure Food and Drug Act

Answer 1

1. 1st federal law regulating drugs

2. Enacted to stop the sale of inaccurately labeled drugs.

Question 2

1914 Harrison Narcotic Act

Answer 2

1. Enacted because of the excessive number of opium addicts in the United States.
2. People could no longer obtain opium without a prescription.

Question 3

1938 Food, Drug, and Cosmetic Act

Answer 3

1. Enacted because of the 1906 Pure Food and Drug Act was not worded strictly enough and did not include cosmetics.
2. Basis for pharmacy law today.
3. All narcotics were required to be labeled “ Warning: May be habit- forming”.
4. Required adequate directions for use ( package inserts)
5. Definite the exact labeling for products and defined misbranding and adulteration as being illegal.

Question 4

1951 Durham-Humphrey Amendment

Answer 4

1. Made the initial distinction between legend drugs (by prescription only) and non prescription (over-the-counter medications).
2. Requires legend drugs be labeled “Caution: Federal law prohibits dispensing without a prescription”.
3. Must be prescription by a licensed practitioner.

Question 5

1962 Kefauver-Harris Amendment

Answer 5

1. Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market (both legend and OTC).
2. Burden put on manufacturing companies to have good manufacturing practices (GMP)
3. Prevented the sale of thalidomide in the United States because children were born with birth defects after use in pregnancy.

Question 6

1970 Comprehensive Drug Abuse Prevention and Control Act.

Answer 6

1. The Drug Enforcement Agency (DEA) was formed to enforce the laws concerning narcotics and their distribution.
2. Created controlled substance I-V
3. Closed system allowing distribution of controlled substances to only those registered with DEA.
   Established strict record keeping guidelines.

Question 7

1970 Poison Prevention Packaging Act (PPPA)

Answer 7

1. Enacted to reduce accidental poisoning in children.
2. Requires most OTC and legend drugs be packaged in child-resistant container.
3. Exceptions to child resistant containers.
   - Upon specific request of physician or written consent of elderly patient.
   - Institutionalized patients.
   - Certain emergency’ medication (sublingual nitroglycerin tablets)

Question 8

Occupational Safety and Health Act of 1970 (OSHA)

Answer 8

1. Ensure a safe and healthful workplace for all employees .
2. Requires a reporting system for job-related injuries and illness.
3. Attempts to reduce hazards in the workplace and conduct audits to ensure compliance with the Act.
4. Established universal precautions.
5. Addresses air contaminants, flammable, combustible liquids, eye and skin protection, and hazard communications standards.
6. OSHA requires use of Safety Data Sheets (SDSs), which are to be provided by the seller of a particular product to the purchaser.

Question 9

1972 Drug Listening Act: National Drug Code

Answer 9

1. Implemented under the authority of the FDA

2. Every drug has a unique 10-digit number divided in to three segments.

Question 10

Orphan Drug Act of 1983

Answer 10

1. Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare diseases.
2. Also covers diseases that affect >200,000 if it could be proved that the cost of developing and testing the drug could not be recorded by the eventual sales.

Question 11

1987 Prescription Drug Marketing Act

Answer 11

1. Maintain legal supply channel from mfg. to distributors and wholesalers.
2. Prohibits sale or distribution of samples to anyone other than who can prescribe them.
3. Controlled the use of drugs in animals.
4. Required the labeling “Caution: Federal law restricts this drug to use by or in order of a licensed veterinarian”.

Question 12

1990 Omnibus Budget Reconcilaiation Act (OBRA 90)

Answer 12

1. Set limitations on Medicare and Medicaid reimbursement for medications.
2. All medication prescribed would be reviewed for appropriateness
3. States that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptions.
4. All patients must be given information on the drug that they taking, its name, when to take it, how long to take it, and any side effects or possible interactions.
5. Act created need for pharmacy technicians .

Question 13

Resource Conservation and Recovery Act (RCRA)

Answer 13

1. General guidelines for the waste management program envisionsed by Congress.
2. Hazardous waste- waste with properties that make it dangerous or potientially harmful to human health of environment.

Question 14

Health INsurance Portability and Accountablity Act of 1996 (HIPAA)

Answer 14

1. Deals with patients right to continuance of health insurance even when changing employers.
2. Confidentially: Technician has direct knowledge of patients medical info on a daily basis, so patients sign a consent form to grant access to this information.
   THIS INCLUDES:
   -Any info created or received by the pharmacy
   -any info relating to patients health
   -Info that may identify a patient.

Question 15

200 Drug Addiction Treatment Act

Answer 15

1. Permits physicians to prescribe controlled substances in schedules C-III, C-IV, C-V to individuals suffering from opioid addiction for the purpose of maintenance or detoxification treatments.

Question 16

2003 Medicare Prescription and Moderization Act

Answer 16

1. Medicare is a government- managed insure program that provides assistance to people older than age 65.
2. Younger than 65 with disabilities and individuals with end-stage renal failure.

Question 17

Isotretinoin Saftey and Risk Manangemetn Act of 2004

Answer 17

1. Regulates use of Accutane.
   - Powerful medication used to treat acne.
2. Can cause severe birth defects and adverse psychiatric effects (depression/suicide)

Question 18

2004 Anabolic Steroid Control Act

Answer 18

1. Placed anabolic steroids on Schedule III
2. Harsher penalties for the abuse of anabolic steroids and their misuse by athletes.
3. Amended in 2004 (stricter).

Question 19

2005 COmbact Meth Act

Answer 19

1. Bill addresses all areas of maufacturing, law enforcement, and sale of ephedrine and pseudoephedrine, which is used as an ingredient in the preparation of methamphetmine.
2. Strict guildlines: only a licensed pharmacist or technincian may dispense, sell, or distribute.
   - Daily sales limit of 3.6 grams/ 9 g per 30 days.

Question 20

Biologics Price Competiton and Innovation (BPCI) ACt of 2009

Answer 20

1. Created an abbreviated pathway for approval of biological products demonstrated to be bio similar to or interchangeable with an FDA-licensed reference biological product,
2. Lower cost and provides patient acces to crucial biological therapies that they need.
3. Permits the FDA to approve a bio similar product with a designation that is interchangeable with the FDA-licensed reference biological.

Question 21

Drug Supply Chain Security Act

Answer 21

1. Outlines critical steps to build an electronic , interoperable system to identify and trace certain prescription drugs as they distributed in the US.

Question 22

2010 Patient Protection and Affordable Care Act

Answer 22

1. Makes preventive care more accessible and affordable for many Americans.
2. Requires insurance companies to cover all applicants with the minimum standards, including individuals with pre existing conditions.
3. Components of the ACA involve pharmacy professionals such as
   - EHR
   - MTM
   - ACO
   - The Home Demonstration Project.

Question 23

2013 Drug Quality and Security Act

Answer 23

1. Gives FDA greater oversight of bulk pharmaceutical compounding and enhances the agency’s ability to track drugs through the distribution process.
2. Compromises two separate act
   -the Compounding Quality Act
   —Creates a new class of compounding manufacturers that voluntarily register with the FDA as an “Outstanding facility”
   -the Drug Supply Chain Security Act
   —Requires the FDA to create and implement a national tracking system to be used by manufacturers.