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

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