5680 Law Exam 1

Which piece of legislation established FDA, definitions for adulterated and misbranded products

Which piece of legislation requires new drug to be proven safe when used according to labeled directions, developed warnings for  habit forming drugs, included cosmetics and medical devices, basis for GA dangerous drug act

Piece of legislation written by pharmacists establishing two classes of drugs: legend "dangerous" drugs with the wording: "caution: federal law prohibits dispensing w/o a prescription", and non-prescription drugs, required directions, allowed oral prescriptions, regulated prescription refills

Which events helped persuade the passing of the food drug cosmetic act of 1938

Which event persuaded the passing of the kefauver-harris amendment of 1962

Piece of legislation requiring efficacy in new drugs, granted regulation of prescription drug advertising to FDA, required informed consent, reporting of adr, creation of good manufacturing practices, standardized new drug application process

Piece of legislation providing tax and licensing incentives to manufacturers to develop drugs that treat rare diseases, less than 200K ppl

Piece of legislation facilitating generic drugs to market by creating ANDA (abbrev NDA) to prove bioequiv and 180 day exclusivity; gave innovator companies additional 5yr of exclusive marketing after approval, aka drug price competition and patent term restoration act

Piece of legislation establishing controls for distribution and record keeping of drug samples, regulation of wholesalers, banned re-importation of prescription drugs produced in US, allows starter packs, coupons, vouchers; retail pharmacies may not possess any prescription drug samples obtained from any source

Legislation establishing prospective DUR, patient counseling, standard of practice, offer to counsel made by pharmacist

Legislation creating fast track NDA, allowed state regulation of compounding, shortened legend to RX only, creation of supplemental NDA for new uses of existing drugs, encouraged pediatric studies by granting innovator company extra 6mo of marketing exclusivity

Legislation establishing Medicare part D prescription drug coverage, allows center for medicaid and medicare services (CMS) to supervise, includes prescription drug plan and medication therapy management, encompasses four programs

Which drug classes are required in a medicare part d formulary

Which resources are listed in federal regulations as accepted standards; contain monographs of recognized drugs

When is NDA submitted to FDA? what must be included?

Who is contacted for fast track drug review? under what conditions will this be granted?

What are labeling requirements for manufacturer containers (stock bottles)

What are requirements for OTC labels

Which ingredients require special warning labels for allergies

Which products require special warning labels for amount dispensed

What is the expiration date for unit dose repackaging

Expiration date for non-aqueous solutions compounded with solid drugs

Under GA law, who can prescribe?

What are requirements for a CII prescription

In what conditions may a CII prescription order fax be used as original hardcopy