Pharmacy Law MPJE Exam: Federal Law Graded A

Pharmacy Law MPJE Exam: Federal Law Graded A What did the Federal Controlled Substances Act do? Why was it implemented? concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Legislators very Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? Prohibited the adulteration and misbranding of foods and drugs in interstate commerce; DID NOT have to be proven safe or effective; did not require the label to list ingredients, directions for use, or provide warnings What did the Food, Drug, and Cosmetic Act do? (started in 1938) Provides for the comprehensive regulation of all drugs introduced into interstate (and most intrastate) commerce Under this act no new drug may be marketed and sold unless it has been proved SAFE ONLY for its intended use and approved by the FDA Labels must contain adequate directions for use and warnings about habit-forming properties of certain drugs Describe the FDCA The purpose of the FDCA is to protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices; provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA; also started the labeling requirements; applies to devices as well; all drugs before 1938 are exempt from the requirement that new drugs be proven safe If you get in trouble with the board of pharmacy can you get in trouble with the government too? What about the a lawsuit with a patient? Yes, you can have an administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same offense What did the Durham-Humphrey Amendment of 1951 do? Established 2 classes of drugs; prescription and OTC Allows refills on prescriptions and oral prescriptions Per the Durham-Humphrey Amendment; what must be labeled on a prescription medication Caution: federal law prohibits dispensing without a Rx; they do not need adequate directions for use like OTC (talking about the MANUFACTURERS label here; there is no take this medication x amount of times daily on the manufacturer labeling) What did the Kefauver-Harris Amendment of 1962 do? safe but also EFFECTIVE Required all drugs to not only be proven Transferred the regulation of drug advertising from the FTC to the FDA The efficacy requirement made by the Kefauver-Harris Amendment included all drugs marketed during what time period ; drugs produced before 1938 were just grandfathered in and did not have to prove their efficacy What did the Orphan Drug Act of 1983 do? Provided tax and exclusive licensing incentives for manufacturers to develop agents for the treatment of rare disease or conditions (those conditions that affect < 200,000 Americans) What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? Made generic drugs more readily available to the public and at the same time provided incentives for manufacturers to develop new drugs Eliminated the need for generic to prove safety and efficacy thus allowing new generics to get approved more easily What did the Prescription Drug Marketing Act of 1987 do? recordkeeping requirements for prescription drug samples Established sales restrictions and Prohibits hospitals and other healthcare entities from selling drugs to other businesses (because the hospitals were getting the drugs for a discount then reselling them) Requires state licensing of wholesalers Prohibits ANY SAMPLES for any reason in a retail pharmacy Bans importation of prescription drugs except by manufacturers and for emergency use Mandates record keeping requirements for drug samples for 3 years What is the Prescription Drug User Fee Act of 1992 Drug companies volunteered to pay tax and the money was used to hire more FDA scientist in hopes to speed up NDA reviews; however the price of drugs just went up to cover the fee being paid by the drug manufacturers What did the Dietary Supplement Health and Education Act (DSHEA) of 1994 do? Provided laws on the regulation of dietary supplements; forced the FDA to treat these products more as food than drugs Define dietary supplement per the law A product that is intended for *ORAL* ingestion, intended to supplement the diet, and contains any one or more of the following: a vitamin, mineral, herb or other botanical, an amino acid, dietary substance or use by humans to supplement the diet by increasing the total dietary intake and a concentrate, metabolite, constituent, extract or combination of the previous. All dietary supplements must be claimed as drugs or anything else on the labeling A dietary supplement; they CANNOT say they are Dietary supplement manufacturers may not make these claims Disease Claims Dietary supplement manufacturers may only make these types of claims Structure / Function The label can't say that it will cure or prevent but it can say "will support or maintain" Dietary Supplements must have this on the labeling "This statement has not been evaluated by