Social Scence / Law / CivitLaw Florida MPJE 2022 > TRstudlerstoday We 49 (19 reviews) Others also viewed these textbooks x Students also viewed H17 Princip RE2 Level Chap 6 Module & Less 3 Court ts Terms in this set (1133) " SAFE AND EFFICACIOUSPrescription Drug Marketing Act of 1987 Prevents recimportation ofa drug into US Prohibited hospital anc healthcare entities from reselling ther pharmaceuticals Bans sale, trade or purchase of prescription drug samples Mandates the storage, handling, and record-keeping requirements for prescrintion drug samples “A.community pharmacy that s NOT affilated w/ a healthcare entity may NOTbe in possession of prescription drug samples" Prohibits re-sale of prescription drugs purchased from hospitals or healthcare facies - done to prevent civersion of drugs dve to price diversion since hospitals receive Lower prices for crugs than community pharmacies Drug Quality and Security Act of 2018, (oosa) "Amendments (DE@A & DSCSA) to the FOCA that addressed two primary topics: 1. Large-scale compounding by pharmacies 2, Establishment ofa framework fora uniform track-and:-trace system for Rx drugs thoughout the supply chain to prevent counterfeltcrugs [Drug Compounding Quality Act (OCGA) ‘Maintains traditional compounding regulations but establshes new section to FOCA that allows faites that are compounding sterile pharmaceuticals fo recister with FDA 2 outsourcing facility (5038) These facties ae exempt from new drug provisions, adequate directions for use, and drug track/trace provisions ‘passed in response to fungal meningitis outoreak in 2012 due to contaminated injectable steroids [What sa 505A pharmacy? Traditional pharmacy that compounds for specific patients pursuant to prescriptions (no (cGMP required) “Follow USP 797"** Interstate cistrbution of compounded drugs i mite to 8% ofthe total prescription ‘orders dispensed or dstributed by such pharmacy (effective 10/22/22 in FL) [Wat are requirements for outsourcing ‘cities? Have a icensed pharmacist Register as an outsourcing facity Report o the Secretary of HHS on registering and every 6 months. Be inspected by the FDA Report serious adverse events within I days Label products with identiying statement as compounded products, ‘Only compound bulk crugs that have a clinical need and/or on shortage NOT EXEMPT FROM cGMP[Drug Supply Chain Security Act (OSCSA) “Track and Trace Amendment™ Uniform national framework for an electronic track-and-trace system for rx drugs a8 thay move through the supply chain & sets national standard for states to license drug ‘wholesale alstributors - Apolies to Rx drugs for human use in finshed dosage form - Does NOT apply to blood/blood components, radioactive drugs, imaging drugs, ‘some IV product for fluid replacements, dialysis solutions, medical gases, ‘compounded drugs, medical convenience kis containing drugs, certain combination products sterile water, and products for irrigation ~ Manufacturers have to provide transaction data for each produc sola Fw long must vaniaction data be maintained by each supply chain partner? years FOA Form son) Track and trace form to report llegtimate produc fo the FDA “ust also notily tracing partners within 24 hours" jtaproductis Megtimate, when must [Pharmacies noifyrading partners? Within 24 hours [What license must pharmacies hat are feistibuting’ have? ‘Wholesale distibution conse [What are the only exceptions to having a kistrbution Ucense and passing transaction fata T When the distribution & between two entities that ae affiliated or under common ‘onnership 2. When a espenser is provicing product te another dispenser on a patient-specific basis |3. When a cspenser is dstibuting under emergeney medical reasons 4. When a dispensers distributing “minimal quantities" to a licensed practioner for office use‘What is adulteration? Wacug contain any fithy, putrid, decomposed substance ~ prepped or stored in unsanitary concttions does not meet ans is manufactured, processed packed, or held in any estabishment where the owner denies/refuses inspection - composed of any poisonous or deleterious substance which may contaminate it Includes unsafe color adattve ~ product claims to meet USP standards and its strength or qualty does not meet those standards -contains drug recognized in or not official compendia, but its strength, purity, oF ‘quality is lower than the offical standards mixed or packed w/ any substance that reduces its strength or quality, oF rug has been substituted in whole or in part [Wat is misbeanding? Tabelis defacedfase or misleading Labeling s missing any of the require information (or both Rx and OTC) itis drugs table to deterioration unless packaged or labeled accordingly Container is made, formed, oiled to be misleading Drugs exact imitation of another drug or offered forsale under name of another drug Itis dangerous to healtn when used inthe dosage or manner suggested inthe labeling It is packaged or labeled in violation ofthe Poison Prevention Packaging Act"What information must be on a preseription lerug’s manufacturers labeling? Name andl address of manufacturer packer, or isvibutor Brand and/or generic of rug Net quantity (weight, aly, oF dosage unis) Weight of active ingrecfents per dose Federal Rx Only for legend drugs Route of administration (unless taken or Any special storage requirements Manufacturers control # (lt 2) Expiration date [Adequate info/drections for use (package insert for RX) Pink = unique to RX REQUIREMENTS ONLY [When isthe only tine a prescription drug product is exempt from the manufacturer's labeling requirements? Wihen iis dispensed purevant toa vali prescription therefore, a pharmacist dspentes a Rx without authorization, the drug becomes “misbrandad’ even iit is labeled correctly ~ pharmacists must have an rin order to dspense the prescription product or it willbe misbranded "What information must be on 2 OTC drug's manufacturer’ labeling? Principal diplay panel with statement of identity of the product Name and address of manufacture, packer, or distributor Net quantity Cautions and warnings forthe user [Adequate directions for safe and effective use Drug Facts panel (w/ proper content & format) Blve = unique to OTC REQUIREMENTS ONLY[Wat is tequied on the Drug Facts Panel on (OTC drugs? “waluses Question Peoples AUDIO" ~ im aware this makes no sense Active ingrectents Purpose Use(9)- indications Warnings Directions Other necessary Information Inactive ingredionts (alphabetical ordes) vestions? (Optional) followed w/ telephone number ‘Rattterated oF Misbranded: Misling @ Rx Misbranded| Jah the wrong crug, strength oF directions for use ‘Kavlterated or Misbranded: A misled Bot prescription involves the wrong strength of the drug prescribed ‘wrong drug, strength, or directions on label = misbranded wrong strength of prescribed drug = adulterated ‘Reuiterated or Misbranded: A crug asa RREMS program and is prescribed or ‘ispensed without meeting the requirements bof the REMS Misbranded| - bjc the REMS program is part of the official labeling ofthe drug ‘Ravtterated or Misbranded: The advertng | Mbranded for promotion of a compounded drug that is {alse oF misleading Raulterated ‘Adulterated of Misbranded: An expired ‘érug product in a manufacturer's bottle bic after the expiration date the strength cannot be assured if pharmacist filed a Rx with an expired drug but labeled the expiration date to be later than what the manufacturer sai, then it would also be misbranded ‘Rattterated oF Misbrandedt A pharmacist ‘counts a medication on atray that has residue from another meccation adulterated [Keutterated or Misbrandedk A pharmacist Stores inventory ina room or refrigerator |ynere the temperature is not adequately ‘conttolled Aadaterated ‘Rattterated oF Misbrandedt A pharmacist stores a specific product incorrectly, such as “stocking a medication on a pharmacy shett Instead of in the refrigerator as required Raulterated [Keuiterated or Misbranded: A pharamacit {als to cspense a medication in a child Feslstant container when requited Misbranded|