Pharm Laws

Question 0

Food, Drug, & Cosmetic Act (FD & C)

Answer 0

Manufactures must file a NDA (new drug ap) with the FDA before it can be approved for market

strength, purity, and safety must all be labeled on the medication

Question 1

Pure Food and Drug Act

Answer 1

no distribution or sale of adultered/misbranded food or drugs

must be prepared and packed in sanitary conditions, so unsafe colors or additives, and they must have consistent strength, quality, and purity as they are labeled. If product is habit forming, it must be labeled, and directions for use must be on label.

Question 2

Durham Humphrey Amendment

Answer 2

Prohibited dispensing script (legend) meds without a prescription bc there was a general lack of understanding of the drug/effects

scripts could also be placed over the phone.

Question 3

Kefauver-Harris Amendment

Answer 3

script & non-script meds must be pure, effective, and safe to use on humans.

script advertising was supervised by the FDA

drug manufacturers must register and allow for inspection.

Question 4

Controlled Substances Act

Answer 4

Pharm industry must maintain records for certain meds, and it also divided drugs into classes/schedules. Schedule 1= high abuse potential, schedule V = low abuse potential

Question 5

Schedule 1 meds

Answer 5

No accepted medical use and high abuse potential

LSD, Crack, Heroin, etc.

Question 6

Schedule II Meds

Answer 6

medical use, and a high abuse and dependance potential

amphetamines (adderall, ritalin), percacets, fentanyl, methadone

Question 7

Schedule III

Answer 7

Medical use, less abuse potential than schedule II

Combo narcotics, like Tylonal 3

Question 8

Schedule IV Meds

Answer 8

Medical use, and less abuse potential than 1,2,3.

Benzodiazapines (lorazepam and alprazolam). Hypnotics (zolpidem or ambien)

Question 9

Schedule V Meds

Answer 9

Medical Use, and less potential than 1,2,3,4.

Lomotil or cough preps w/codeine. Robotussin AC.

Question 10

Poison Prevention Packaging Act

Answer 10

Pill containers must be difficult for kids to open.

Cannot be opened by 80% of kids under the age of five, and can be opened by 90% of adults.
Exceptions: Nursing homes/medical settings, birth control, bulky meds and corticosteroid tablets

Question 11

Occupational Safety and Health Act

OSHA

Answer 11

Regulations for physical workplaces, including machinery.

Information must be on hand about chemicals (flamable, toxicity, etc)
Must be eyewash stations, proper needle disposure places, spill cleanup, etc.

Question 12

Drug Listing Act

Answer 12

Medications must have unique individual codes NDC

00378 —– 2074——————–01
manufacturer) (product & strength) (package size

Question 13

Federal Hazardous substances Act

Answer 13

Must be proper disposal of hazardous materials (needles, etc)
Disposal must be in well marked container

Question 14

Orphan Drug Act

Answer 14

Offers financial incentives to manufacturers working on drugs for rare diseases (less than 200,000 known cases)

Question 15

Drug Prices Competition/Patent term restoration

Answer 15

Encourages the development of new drugs by offering extended patents

helps w/the high cost of meds by streamlining the approval of generic ones.

Question 16

Prescription Drug Marketing Act

Answer 16

No sample drugs can be given to anyone who cannot prescribe them

No reimportation of a drug into the US by anyone other than the manufacturer

Question 17

Omnibus Budget Reconciliation Act

ORBA

Answer 17

refills/fills of prescriptions for medicaid patients must be kept on file

Mandatory patient councilling by request, done by the pharmacist

patient files must be review to ensure the safety of the medications

Question 18

Anabolic Steroids Control Act

Answer 18

CSA regulates anabolic steroids, which are a schedule III drug.

Question 19

Health Insurance Portability & Accountability Act

HIPPA

Answer 19

3 Ways to store patient records to improve the continuity and portability of health insurance.

1. Privacy: patients have access to their own records, accounting of disclosures, and communication of health information
2. Protected health information (security regulations)
3. Transaction Standards: common set of standards for the transmition of claims. Each patient must be made aware of HIPPA (electronic sig at the register:)

Question 20

FDA Modernization Act

Answer 20

safe pharmacy compounding and regulation of medical devices

patients have more access to experimental medication and devices

“Rx only” must be on all labels

Question 21

Medicare Prescription Druge Improvement & Modernization act of 2003

MMA

Answer 21

provide voluntary prescription drug benefits to medicare patients

Question 22

Combat Meth Epidemic Act

Answer 22

Ephedrine/pseudophedrine must be locked behind the pharmacy counter

3.6 grams of ephedrine per person at one time, no more than 7.5 grams a month

and ID is required to buy ephedrine, and the ID is entered into a national data base

Question 23

State Boards of Pharmacy

Answer 23

BOP- set state specific laws and regulationsd.

administer personal licensing and exams

Question 24

DEA

Answer 24

focus on major violators of controlled substances act who use violence

bring offenders to justice while promoting reduction of illicit drug use

Question 25

FDA

Answer 25

enforce the safety and effectiveness of food and meds.

Med-Watch: a way to receive info about adverse side effects of drugs, and it is part of a pharmacy tech’s ethical code to report things to Med-Watch

Question 26

Joint Commission

Answer 26

Accredit and certify healthcare organizations in the US

Places emphasis on protecting patient safety.

Question 27

United States Pharmacopeia Act

USP

Answer 27

sets the standards for prescriptions, over the counter meds, and dietary suppliments made and sold in the US (strength, purity, quality, consistency)

Question 28

USP-797 Act

Answer 28

sets the safety/sterility of compounding medications. Protects patients from things that might be spread through the use of pharmaceuticals

-enforces proper training, sterile areas, quality assurance, and proper ventilation

Question 29

National Boards of Pharmacy

Answer 29

Protector of the public by having and enforcing uniform standards throughout the pharmaceutical industry