TX MPJE Summary Notes Latest Updates

TX MPJE Summary Notes Latest Updates Food Drug and Cosmetic Act of 1938 - Followed deaths by sulfanalimide elixier; required new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, costmetic, and medical device safety Durham-Humphrey Act of 1951 - Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and established GMPs; gave FDA jurisdiction over Rx drug advertising Prescription Drug Marketing Act of 1987 (4 things) - PDMA; bans reimportation of Rx drugs and insulin produced in US (except by manufacturer); bans sale, trade, or purchase of Rx drug samples in the pharmacy; exception is pharmacies owned by charitable organizations or by city/state/county govt providing care to indigent population; may only be provided at no charge to patient; mandates storage, handling, and recordkeeping requirements for prescription drug samples; prohibits, with some exceptions, resale of prescription drugs purchased by hospitals Drug Quality and Security Act of 2013 (2 topics) - Drug Compouding Quality Act; Drug Supply Chain Security Act Drug Compounding Quality Act - Maintains traditional compounding regulations but establishes new section to FDCA that allows facilities that are compounding sterile pharmaceuticals to register with FDA as outsourcing facility; These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions Drug Supply Chain Security Act - Provides uniform national framework for electronic track/trace system for Rx drugs through supply chain (exempt are blood products, radioactive drugs, imaging drugs, certain IV fluids, dialysis solutions, medical gases, compounded drugs); must provide "transaction data"; pharmacies that are distributing (instead of dispensing to patient), must have wholesale distribution license The only exemptions to having "distribution license" under DSCSA are: (4) - When two entities are same ownership; dispenser in providing product to another dispenser on a patient specific basis; distributing under emergency medical reasons; when distributing "minimal quantities" to a license practitioner for office use "Transaction data" under DSCSA includes... - Transaction information (drug name, strength, dosage form, NDC, size/number of containers, date, name and address of owners; Transaction history (paper/electronic statement of prior transaction info all the way back to manufacturer; Transaction statement (done by seller saying they are legit) 2 prohibited acts under the FDCA - adulteration and misbranding Adulteration: a drug is adulterated if.... - Contains filthy/decomposed substance; prepared in unsanitary conditions; methods do not conform to CGMPs; container is composed of poisonour substances; unsafe color additive; falls below USP quality/purity standard; strength differs than what it represents Misbranding: a drugs is misbranded if... - Labeling is false or misleading in any way; Prescription drug label and manufacturer label fails to contain: name/address of manufacturer, packer, or distributor, name of drug, quantity, weight of active ingredient, "Rx only", route of admin, special storage instructions, lot number, expiration date, package insert; OTC fails to contain certain things (separate card); drug is liable to deterioation; container is misleading; drug is exact imitation of anotehr drugs; dangerous to health if used as suggested in labeling; packaged/labeled in violation of poison prevention packaging act OTC product is considered misbranded if fails to contain.... - Principal display name; name/address of manufacturer; net quanitity; cautions/warning; adequate direction for safe/efffective use; content (active ingredients, purpose, use, warnings, directions, inactive ingredients, questions and phone number) Which food dyes must contain warning in "precautions" sections that may cause allergic reaction - FD&C Yellow #5 and #6 Aspartame must contain warning in preacautions sections saying: - Contains phenylketonurics: contains phenylalanine ___ mg per ___(dosage unit) Sulfites are often used as ______ and must contain what warning - often used as preservative; contain allergy warning Mineral oil labeling - Warning must say to only take at bedtime and not used in infants unless under advice of doc; label also cannot encourage use in pregnancy Wintergreen oil labeling - AKA methyl salicylate; any drug containing 5% wintergreen oil (often used for flavor) must include warning that other use may be dangerous and should keep out of reach of kids Sodium phosphates labeling - Limits amt of Na phos oral solution to not more than 90mL per OTC container Isoproterenol inhalation prep labeling - Requires warning not to exceed dose prescribed and to contact doc if difficulty in breathing Potassium salt prep for oral ingestion labeling - Requires warning regarding nonspecific small-bowel lesions consisting of stenosis with/without ulceration associated with administration of enteric-coated thiazides with K salts Ipecac syrup labeling - Boxed and red letters "for emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital ER immediately for advice"; "warning: keep out of reach of children. Do not use in unconscious person"; dosage must appear (usual dose is 1 TBSP or 15 mL over 1 year old); container may only be sold in 1 oz (30 mL) container Phenacetine (acetophenetidin) labeling - must contain warning about possible kidney damage when taken in large amounts or for long time Salicylates labeling - ASA and other salicylates must have special warnings for use in children including risk for Reye's syndrome; retails containers of 1.25 grain (pediatric) aspirin cannot be sold in bottles with more than 36 tablets Alcohol and OTC pain labeling - Internal analgesics and antipyretics including APAP, ASA, ibuprofen, naproxen, ketoprofen, are required to have a warning for persons consuming 3 or more alcoholic beverages per day and to consult with doc before taking APAP OTC labeling - Must have acetaminophen prominently displayed; must warn about liver toxicity; warning about not using other APAP products and warfarin use NSAID OTC labeling - Must include NSAID term prominently; must contain "stomach bleeding" warning Tamper-evident packaging in OTC products - Manufacturers and packages of OTC drugs (except dermatological, dentrifrice, insulin, or lozenge products) for retail sale must have tamper-evident package Repackaging of OTC products - A Pharmacist that repackages OTC products would be subject to CGMPs and would have to provide tamper-evident packaging if offered for sale to public When OTC product is prescribed and filled as a prescription, the OTC labeling requirements do... - NOT have to be followed; prescription drug labeling requirements would includes prescriber's direction for use and any instructions for refill would apply as would expiration dates (1 year) FDA drug and device recall classifications - Class I, II, and III; technically FDA does not have legal authority to order a recall of a drug but do have authority to recall medical devices; but FDA can seize products, so most companies will comply when FDA requests them to recall a drug Class I FDA recall - Reasonable probability will cause serious AE or death Class II FDA recall - May cause temporary or medically reversible AE or where probability of serious AE is remote Class III FDA recall - Not likely to cause adverse health consequences Prescription advertising regulated by... - FDA OTC drug advertising regulated by... - FTC (federal trade commision); since are considered consumer products Advertising of prescription drug prices (including by pharmacists) is considered... and is considered exempt if the following are met.... - reminder advertising under FDA regulations; only purpose is to provide info on price (not safety, efficacy, or indications), contains proprietary name, generic, strength, dosage form; may include other services provided; price shall include all charges to customer PPI - Patient package insert; this is DIFFERENT than package insert PPI is supplied by... and required to be... - Supplied by manufacturer and written for layperson; required to be given to patients when prescriptions for certain products are dispensed PPI are currently required for... - oral contraceptives; estrogen containing products; progesterone containing products PPI in the hospitalized patients must be.. - provided prior to first administration of the drugs and every 30 days thereafter Failure to provide a PPI for these drugs would cause them to... - be misbranded MedGuides are similar to PPI but... - without requirement for institutionalized patients FDA requires MedGuides for drugs when.... - Patient labeling could prevent serious AE; product has serious risk relative to benefits; patinet adherence is crucial; must have FDA approval before sent ot pharmacies; over 300 drugs that require them now REMS - Risk Evaluation and Mitigation Strategies REMS purpose - Manage a known or potential serious AE associated with a drug or biological product; FDA dictates if it is necessary A REMS can include a.... - MedGuide; PPI; communication plan; elements to assure safe use (EASU); implementation system Elements to assure safe use (EASU) may include.... - Special training, experience, or certification of HCPs prescribing the drugs; special certification for pharmacies; drug may only be dispensed in certain settings; drugs is dispensed with documentation of safe use conditions such as labs or pregnancy test; each patient is enrolled in a registry iPLEDGE associated with... - REMS for isotretinoin (Accutane); only 30 day supplies; no refills allowed; females must document negative pregnancy tests NDC number - National Drug Code number NDC purpose - 10-11 character number that ID's a particular drug by manufacturer, product, and package; first 4-5 are manufacturer, next 4 is drug, last 2 digits is package FDA and NDC - FDA does not mandate NDC on labels; and having a NDC does not denote FDA approval; however NDC is often required for reimbursement Compounding versus manufactured per legal distinction - Compounding is recognized as part of pharmacy practice and is generally regulated by states; drug manufacturing is generally regulated by FDA The compounding quality act of 2013 amended the FDCA to create a new type of FDA registritation called... - Outsourcing Facilities Outsourcing facilties are AKA - 503B facilities Outsourcing facilities are permited to... - compound sterile products wihtout receiving patient-specific prescriptions or medication orders; they are primarily regulated by FDA and subjects to CGMPs Compouding pharmacies not registered with FDA as outsourcing facilities are AKA - 503A facilties/pharmacies 503A pharmacies may only... - compound products pursuant to an individual prescription or medication order; they are permitted to do only limited anticipatory compounding and are primarily regulated by the states and subject to USP 797 quality standards for sterile compounding What document to use to determine compounding vs manufacturing - 2013 Compliance Policy Guideline 10 factors that say something is compounded vs manufactured - Compounded for a individual patient; performed by a licensed pharamcist or physician based on a prescription order or in limited quantities before a medication order is received; compounded in compliance with USB chapters on compounding; compounded with bulk products by an establishment registered with FD&C act; compounded with bulk products accompanied by valid certificates of analysis for each substance; compounded with ingredients (other than bulk drug substances) that comply with applicalbe USP or NF monograph; drugs does not appear on list that includes drugs that have been withdrawn/removed from market due to safety/inneffectiveness; compounded product is not essentially copies of commercially availabily drug products; drug product is not ID'd by FDA as reasonably difficult to compound; drug product is compounded in a state than has entered into a memorandium of understanding with FDA that addresses interstate movement, or if no MOU, the pharmacist does not compounded more than 5% out of state