MPJE ILLINOIS VERIFIED ANSWERS

MPJE ILLINOIS VERIFIED ANSWERS Form to send to DEA for destroying controls DEA Form 41 Controlled substance theft/loss form? DEA Form 106. Must also be sent to DPR. Doesn't define what you have to report; err on the side of caution! How long to send in theft/loss form? 1 business day Do you need to report pseudophedrine as stolen? No, it is a C5 under state law but not controlled under federal law Difference between detox and maintenance treatment with methadone/LAAM Detox = 21 days, Maintenance 21 days. How do you know if a physician is allowed to treat addictions on an outpatient basis with buprenorphine (subutex/suboxone)? If they have a separate DEA # that starts with the letter X Anytime you dispense a schedule II-V.....tell who and after how long? Report to Illinois Prescription Monitoring Program not more than 7 days after. (Fine is $100/day). Hospitals exempt. Also from narcotic tx program and infusions in house. Prescriptions from the ER are exempt from reporting to PMP if? They are for a 72 h or less supply All drug manufacturers and repackagers are required to register with FDA. If they fail to do so, their products are deemed...... Misbranded Required licensing of biologics establishments, inspections of vaccine manufacturers and premarket approval of vaccines Virus-Toxin law of 1902 Prohibited the marketing of adulterated and misbranded food and drugs Food and Drug Act of 1906 Required demonstration to FDA of the safety of drugs prior to marketing, allowed FDA to inspect facilities, allowed FDA to seek injunctions from courts, provided legal definitions of drugs, devices, cosmetics and labeling Federal Food, Drug and cosmetic Act of 1938 Distinguishes between prescription and OTC drugs Durham-Humphrey Amendment of 1951 Requires drug manufacturers to show the effectiveness of their products as well as safety, to report adverse events to the FDA, and to ensure that they disclose the risks and benefits. Informed consent required for studies. FDA was given jurisdiction over rx drug advertising. Need to submit an NDA! Kefauver-Harris Amendment of 1962 (Thalidomide) Clarified the definition of device and categorized medical devices based on risk Medical Device Amendments of 1976 Anti-tampering regulations Cosmetic liquid oral hygeine products, vaginal products, contact lens solutions and most OTC drugs need to be tamper resistant. Packaging must be distinctive by design and must indicate to consumers. Ex) flister packs, film wrappers, aerosols, tape seals, break away caps, foil. Drugs intended for the tx of rare diseases and conditions Orphan Drug Act of 1983 Concerns of drugs being sold that were counterfeit. Requires states to license wholesale distributors of rx drugs, ban the reimportation of rx drugs, except by the manufacturer. Mandate record keeping for drug samples. Ban counterfeiting of drug coupons. Prohibit resale of rx drugs. Prescription Drug Marketing Act (PDMA) of 1987 and Prescription Drug Amendments of 1992 Allows FDA to accept user fees from drug and biologic companies in return for committing to review new drug and biologic products within certain time frames Prescription Drug User Fee Act (PDUFA) of 1992 Allowed the use of FDA approved health claims of food labels and required a uniform format for the nutrition info Nutrition Labeling and Education Act (NLEA) of 1990 Established labeling requirements, allowed "nutritional support statements" describing the effect of the supplement. Dietary Supplement Health and Education Act (DSHEA) of 1994. FDA must prove supplements are UNSAFE as opposed to manufacturers having to prove SAFE. Established fast-track approval for certain new drugs and accelerated approval for innovative devices by exempting certain devices from premarket notification requirements. Food and Drug Modernization Act (FDAMA) of 1997 Form to register with DEA to dispense controls Form 224 (224a for renewal) When does a pharmacy's license expire? March 31 on even years When does a pharmacy need to register as a distributor? If it participates in joint buying activities and is the location from which drugs are stored and shipped to other pharmacies OR its annual distribution of controls to other pharmacies/practitioners exceeds 5% of total dosage units dispensed. When does a pharmacy register as a manufacturer? Purchases controls for purposes of repackaging for sale, Compounds for office use (Not if its aqueous, oleaginous or solids or only up to 20% controls) When to register as detox compounder? Compounds a control for sale to narcotic treatment program (who must be registered with DEA). Suboxone is allowed to be used on an outpatient basis! The only other way to treat addiction is to dispense at a narcotic treatment program. Verification of DEA #s A, B or F then usually letter of last name. M is mid level. Manufacturers or distributors = P or R. Add 1+3+5, 2+4+6 x 2 then add totals and should equal last number. Entry point for newly scheduled controlled drug IV Heroin Schedule 1 LSD 1 Mescaline 1 Marijuana (even medical) 1