Pharm Laws Flashcards
(30 cards)
Food, Drug, & Cosmetic Act (FD & C)
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
Pure Food and Drug Act
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.
Durham Humphrey Amendment
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.
Kefauver-Harris Amendment
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.
Controlled Substances Act
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
Schedule 1 meds
No accepted medical use and high abuse potential
LSD, Crack, Heroin, etc.
Schedule II Meds
medical use, and a high abuse and dependance potential
amphetamines (adderall, ritalin), percacets, fentanyl, methadone
Schedule III
Medical use, less abuse potential than schedule II
Combo narcotics, like Tylonal 3
Schedule IV Meds
Medical use, and less abuse potential than 1,2,3.
Benzodiazapines (lorazepam and alprazolam). Hypnotics (zolpidem or ambien)
Schedule V Meds
Medical Use, and less potential than 1,2,3,4.
Lomotil or cough preps w/codeine. Robotussin AC.
Poison Prevention Packaging Act
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
Occupational Safety and Health Act
OSHA
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.
Drug Listing Act
Medications must have unique individual codes NDC
00378 —– 2074——————–01
manufacturer) (product & strength) (package size
Federal Hazardous substances Act
Must be proper disposal of hazardous materials (needles, etc)
Disposal must be in well marked container
Orphan Drug Act
Offers financial incentives to manufacturers working on drugs for rare diseases (less than 200,000 known cases)
Drug Prices Competition/Patent term restoration
Encourages the development of new drugs by offering extended patents
helps w/the high cost of meds by streamlining the approval of generic ones.
Prescription Drug Marketing Act
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
Omnibus Budget Reconciliation Act
ORBA
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
Anabolic Steroids Control Act
CSA regulates anabolic steroids, which are a schedule III drug.
Health Insurance Portability & Accountability Act
HIPPA
3 Ways to store patient records to improve the continuity and portability of health insurance.
- Privacy: patients have access to their own records, accounting of disclosures, and communication of health information
- Protected health information (security regulations)
- Transaction Standards: common set of standards for the transmition of claims. Each patient must be made aware of HIPPA (electronic sig at the register:)
FDA Modernization Act
safe pharmacy compounding and regulation of medical devices
patients have more access to experimental medication and devices
“Rx only” must be on all labels
Medicare Prescription Druge Improvement & Modernization act of 2003
MMA
provide voluntary prescription drug benefits to medicare patients
Combat Meth Epidemic Act
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
State Boards of Pharmacy
BOP- set state specific laws and regulationsd.
administer personal licensing and exams
