mkt failure: public goods, externalities, natural monopolies, information asymmetry best interest of pt keep records for 2y off-label: manufacturers can only promote off-label use to professionals, doctors can write for any use once approved by fda sources of law: conflicts always follow federal unless state stricter schedule Ill-IV expire in 6mo, 5 refills/mo; no expiration for CIl executive enforce laws (FDA), legislative makes laws, judicial interprets DEA drug enforcement administration, FDA food and drug administration (federal admin agencies) CMS centers for medicare/medicaid servies board of pharmacy (state admin agency) criminal: charged w statute-prohibited crime civil: based upon statute or common law rights administrative: disciplinary determination federal register (daily publication of proposed/final regulations/notices), code of federal registration (compilation of final regulations by subject) tested heavily on amendments
question will be either: select which of the following mandates this amendment required or: which of the following amendments required this mandate
definition of drug/device/combination product/supplement what's federally required on a label (Rx only, expiration date last day of month) USP united states pharmocopeia, HPUS homeopathic pharmacopoeia of US (no specifics) violations of FDCA if adulterated/misbranded class 1 serious/death, 2 temporary problems, 3 unlikely federal anti-tampering act due to tylenol federal side: drug label from manufacturer package inserts: black box warnings, pregnancy warnings (ABCDX, phasing out) NDCfi, how to validate, 1+3+5 plus 2(2+4+6), last digit = last one of NDO preclinical: pharmacological/kinetic/toxicology
phase I: small fi, toxicity, metabolism, elimination, adverse effects phase Il: pts that have disease, efficacy, safety phase lll: clinical setting for efficacy compared to control group
postmarketing surveillance: continue testing after approved after testing NDA submitted for evaluation, ANDA: for drug to become
combination
Risk evaluation mitigation strategies REMS like Medguide doctors undergo training before prescribing opioids: also REM Hatch Waxman: patent can be extended while reviewed by FDA OTC: supplemental NDA, petitions Biologics: biosimilars, purple book; orange book for generic drugs
act (manufacturer to professional advertising) drug ads: nothing false/misleading difference of expiration date (commercially available)/beyond use date (pharmacy compounding preps), antibiotics: liquid has shorter by use date FDA orange book: generic drugs, each state has own substance laws, A/B rated, A: bioequivalence confirmed warfarin, phenytoin, synthroid FDA narrows their limit NTI Ventolin/Proventil, not substitute, B rated to each other, each has its own generic states must register wholesalers as a pharmacist you need to know where the drug comes from (pedigree) differences tax-paid alcohol (compounding in comm pharmacies, from liquor retail) and tax-free alcohol (hospitals for science/med purposes, only for inpatients) rules behind child packaging act, sublingual nitroglycerin exempt only pt authorize non-child proof for all drugs DEA must update schedules, attorney general can schedule drugs manufacturing label must have drug schedule cl-cv 224 (register with DEA), 222 (order CII), 41 (destroy C), 106 (theft/Ioss of C) how to store Cll: disperse in pharmacies/instutition, separate and locked in cabinet if individual practitioner AIW not as bad as search warrant (large amts Cs, long time since inspection) search warrant issued if probable cause, day/night subutex, suboxone NDA letters begin with