Multistate Pharmacy Jurisprudence(MPJE) Exam Review 2023 (FEDERAL LAW) Questions and Answers.

Multistate Pharmacy Jurisprudence(MPJE) Exam Review 2023 (FEDERAL LAW) Questions and Answers. Food and Drug Administration Correct Answer: a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products (P)FDA Correct Answer: Pure Food and Drug Act of 1906 Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) Correct Answer: FDCA Poison Prevention Packaging Act of 1970 Correct Answer: PPPA Controlled Substance of 1970 Correct Answer: CSA Controlled Substance Act of 1970 Correct Answer: What act established the FDA in 1970? DEA (created 1973) Correct Answer: Drug Enforcement Administration Prescription Drug Marketing Act of 1987 Correct Answer: PDMA Omnibus Budget Reconciliation Act of 1990 Correct Answer: OBRA 90 - what does it stand for Adulteration Misbranding Placing into interstate commerce unapproved new drugs Correct Answer: What 3 illegal acts did the Pure Food and Drug Act of 1906 establish Federal Food, Drug, and Cosmetic Act of 1938 Correct Answer: Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for introducing new drugs; gave FDA the power of enforcement Intended Use Correct Answer: A drug is dependent on _____________ Provider, not the user Correct Answer: Intended use is determined by the___________, not the __________ 1. In USP, or NF, or Homeopathic P. 2. Articles INTENDED FOR use in the Diagnosis Cure Mitigation Treatment or Prevention of Disease in man or animal 3. Articles intended to affect the STRUCTURE or FUNCTION of the body (other than food) 4. Any component of the above Correct Answer: Drug Device Correct Answer: Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent A drug works through a chemical reaction and is dependent on metabolism. ; Devices are only recognized in the USP or NF (Not homeopathic) Correct Answer: What is the difference between how a drug works and a device works I. Reasonable assurance of safety and effectiveness (referred to as GENERAL CONTROLS device) II. Insufficient info for reasonable assurance safety and effectiveness III. Pre-market approval Correct Answer: What are the 3 classes of devices Class I Correct Answer: Device class - Reasonable assurance of safety and effectivenss Class III Correct Answer: Pre-market approval cosmetic Correct Answer: Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT SOAP) True Correct Answer: True or False: A item can be both a drug AND cosmetic Label Correct Answer: Written, printed, or graphic on the container or accompanying it Label Correct Answer: What must always accompany the container because it conveys intended use True Correct Answer: True or False: A patient may be given a package insert FDA Correct Answer: Labelling must be ________ approved Contraindications Warnings Precautions Adverse Reactions Correct Answer: What is the order of importance of what is included in a package insert Essential scientific information; not false or promotional evidence of safe and effective clinical pharmacology Correct Answer: What is the required content of a package insert New Drug Correct Answer: Any drug after June 25, 1938 that was subject to the Food and Drug Act of 1906 NDA (New Drug Application Correct Answer: Required of all new drugs ANDA (Abbreviated New Drug Application) Correct Answer: Required of all generic drugs Same: Entity Strength Dosage Form And MUST BE BIOEQUIVALENT Correct Answer: What are the requirements of an ANDA False - just new drugs (prior to interstate commerce) Correct Answer: True or False: Both new drugs and generic drugs must be proven to be safe and effective Adulterated Correct Answer: What a drug is corrupt, debase or made impure by the addition of a foreign or inferior substance or element Misbranding Correct Answer: Label is false or misleading (no label or a false label) Rx only Correct Answer: Caution: Federal law prohibits dispensing without a prescription. (FEDERAL LEGEND) True Correct Answer: True or False: a filled prescription is exempt from misbranding if the drugs has "Federal Legend" and is properly filled Misbranding Correct Answer: Dispensing a prescription without prescription is considered_________ GRAE (generally recognized as effective) GRAS (generally recognized as safe) Correct Answer: New drugs must be Class I Correct Answer: Device class also referred to as General Controls The intentions of drugs or devices: Diagnosis Cure Mitigation Treatment or Prevention of disease in man or animal Correct Answer: What acronym is Doc My Toes are Purple for? 1. Lack of safety without supervision 2. Sponsor's request Correct Answer: What are two ways for an item to be classified as prescription 1. Call your doctor 2. Call FDA at 1-800-FDA-1088 3. Report online at events FDA Adverse Event Reporting System (FAERS) Correct Answer: -database on adverse events and med error reports given to FDA -info used to ID possible safety concerns -manufacturers who receive adverse drug event report must submit info to FDA FDA Recall Class I Correct Answer: Threat to LIfe (what FDA Recall Class) FDA Recall Class II Correct Answer: Temporary or reversible adverse health consequences (what FDA Recall Class) FDA Recall Class III Correct Answer: Not likely to have adverse health consequences (what FDA Recall Class) Class III Correct Answer: What FDA recall class is the most common recall True Correct Answer: True or False: FDA recalls may be conducted on a firm's own initiative by FDA request, Or by FDA order under statutory authority False Correct Answer: A lot number or the National Drug Code is required by law to be put on the manufacturer's container There are no federal requirements regarding product expiration Correct Answer: What is the federal requirement for an expiration date on products that are extremely stable? 2 years from the date of manufacture Correct Answer: What is the proper expiration date on insulin 6 months OR 25% of the time remaining from date of repackaging to manufacturers expiration date, whichever is sooner/less Correct Answer: What is the proper expiration date when repackaging medications in unit-doses? FDCA of 1938 Correct Answer: What act mandates that any new drug must be proved safe and label must include directions for use and warnings? And has to do with recalls, NDC numbers, etc Kefauver-Harris Amendments Correct Answer: What law required prescription medications manufactured between 1938 and 1962 to be effective Phase III Correct Answer: In drug development, in what phase of testing is the largest, involves humans, and gathers data on safety and efficacy Phase IV Correct Answer: In what phase are LONG TERM safety and efficacy are established post marketing approval Drug monograph Correct Answer: What process is used to describe the FDA panel review of ingredients for OTC products to determine safety and efficacy, indications, instructions and warnings? Dietary supplements Correct Answer: Do not require pre-marketing approval Diet supplement; drug Correct Answer: The source of the item determines if an item is a _______ ___________ or a ____________ 30 days Correct Answer: Unless it makes a therapeutic claim, the FDA must be notified no later than _______ after first marketing Vitamin Mineral Herb or Botanical Amino acid Substance used to supplement diet Any component or metabolite Correct Answer: What are the types of dietary supplements Statement on a label Correct Answer: If it has a structure/function claim, it must have a __________________ "This supplement has not been approved by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease Correct Answer: What statement is on a dietary supplement label A therapeutic claim Correct Answer: What is not allowed on a dietary supplement FDA Orange Book Correct Answer: Generic equivalency book, A# is interchangable, shows drugs which are approved drug products with therapeutic equivalency evaluations Equivalent; not equivalent Correct Answer: In the Orange book, A means ________________ and B means ___________________ Pregnancy Category A Correct Answer: Safe in studies of pregnant women Pregnancy Category B Correct Answer: Safe in studies of animals (NO HUMAN STUDIES) Pregnancy Category C Correct Answer: Unsafe in animals; no human studies and therapeutic effect outweighs potential risk Pregnancy category D Correct Answer: Unsafe in HUMAN studies but therapeutic effect outweighs potential risk Pregnancy category X Correct Answer: Unsafe in human studies; RISK outweighs potential benefits June 1, 1999 Correct Answer: Medication guides were mandated by the FDA Lotronex Estrogens Progestational drugs Oral contraceptives Correct Answer: What drugs are required by be dispensed with a medication guide 1. Clear English, non-technical language 2. Label heading "Medication Guide" 3. Brand name and generic name immediately under heading 4. Consistent with package and insert 5. TEXT IS 12 POINT FONT 6. Boxes, bold, underlining, and highlight important information 7. Must say at the bottom "This medication guide has been approved by the Food and Drug Administration Correct Answer: Describe the medication guide (7 things) .