Pharmaceutical Training Seminar – 2016 Year-End Reports UN Reporting and Quota Section [email protected] (202) 307-7184 Pre-YERS History Ø ARCOS system was developed to track the distribution of controlled substances. Manufacturer >> Distributor >> Various Retail Outlets Ø Timeliness of registrants completing reports makes it less suitable for certain DEA functions. It was decided that ARCOS data could not be used to comply with UN mandates YERS History Ø In the early 90’s, the DEA created year- end reports to facilitate: l Establishment & Revision of • Aggregate Production Quotas (APQ) – CI, CII • Assessment of Annual Needs (AAN) – List 1 • I ndividual registrant quotas (IQ,MQ,PQ) l Monitoring the “80/20” NRM import rule l UN-treaty mandated reporting Year-end Reporting Benefits Ø Provides secure web-based database system Ø Preloads your available drug codes, historical data Ø Performs calculations Ø Generates error messages for possible incorrect entries or when “specify” fields are not completed Ø Moves submitted reports to completed list Year-end Reporting Reports need to be completed by: l DEA REGISTERED MANUFACTURERS l Schedule I and II controlled substances l Psychotropic drugs on UN’s “green list” l DEA REGISTERED LIST 1 IMPORTERS l Ephedrine l Pseudoephedrine l Phenylpropanolamine Please Note Ø Due by January 31 after end of reporting CY Ø Separate report required for each substance if l Quota was issued for that reporting CY l Inventory processed or carried over from an earlier CY l Psychotropic drug on UN’s ‘green list’ l Newly scheduled CI or CII drugs Ø Quantities reported should expressed as: l Anhydrous acid, base or alkaloid l GRAMS Accessing YERS Online www.deadiversion.usdoj.gov Reporting Year-End Reports YERS Online New Accounts: complete Secure website user agreement, print, sign, & email to ODE Quota to receive corporate administrator log-in Enter DEA issued user name & password Corporate Administrator Login Create New Corporate User Account Corporate User Login Corporate User Login Confirmation Report Selection Menu Report Selection Year-end Reporting UN mandated individual reports for the following optical isomers: l Amphetamine • d-amphetamine • l-amphetamine • d,l-amphetamine l Methamphetamine • d-methamphetamine • l-methamphetamine • d,l-methamphetamine l Tetrahydrocannabinols • Delta-9-THC • All Other Tetrahydrocannabinols “For Sale” vs. “For Conversion” l Codeine l D-Amphetamine l D-Methamphetamine l Diphenoxylate l Hydrocodone l Morphine l Noroxymorphone l Oxycodone l Oxymorphone “For Sale” vs. “For Conversion” For Sale: substance used to manufacture products containing same basic class which is bought from the bulk manufacturer. - involves ~95% of the quota applications ex: Codeine (for sale) codeine/APAP For Conversion: substance used to synthesize a different basic class. ex: Codeine (for conversion) hydrocodone Report Selection Confirmation Year-end Reporting: Inventory Ø Inventories include amounts held by the registrant under manufacturer, importer, exporter or distributor registrations at that physical location Ø “Bulk Controlled Substance” is the amount of raw material in inventory Ø “In-process” - i.e. beads not yet encapsulated Ø “Non-saleable Materials” includes any non-saleable inventory - i.e. retains, product development, pending destructions Inventory Year-end Reporting: Acquisitions Ø Only material which was obtained against a quota should be reported under “Domestic Procurement” or “Manufactured/ Produced/ Synthesized/ Extracted” Ø Material acquired through authorized replacement of destroyed material is reported under “Other Acquisitions to be Accounted For” Acquisitions Year-end Reporting: Dispositions Ø Material acquired with current year’s quota Ø Material from previous year’s inventory • Domestic sales / transfers • Exempted products • Exports • Returns • Authorized destructions Dispositions Summary Totals Confirmation Completed Reports Year End Report Manufacturing Selection Menu Year-end Reporting Ø Narcotic Raw Materials reporting is required by 1961 Single Convention on Narcotic Drugs: l Opium l Concentrated poppy straw (CPS) Ø Alkaloids in CPS which are reported: l Codeine l Morphine l Oripavine l Thebaine Year-end Report for Bulk Manufacturers Ø To be completed by a manufacturer who manufactures, produces, synthesizes or extracts a bulk Schedule I or II controlled substance Ø In-process inventories are to be reported as end-product inventories, not as precursor inventories l based on actual assay of in-process material, or l based on historical yields Conversion Reporting Ø To be completed by a manufacturer who utilized a basic class for conversion to another controlled or non- controlled substance l Example 1 - If a manufacturer used phenylacetone to synthesize amphetamine, the amount of phenylacetone used and the amount of amphetamine synthesized would be reported on this worksheet l Example 2 - Manufacturer received a “codeine (for conversion)” manufacturing quota and utilized it for purposes of making “hydrocodone (for sale)”. Ø This is NOT to be used to report: l the manufacture of dosage forms l the manufacture of exempt or excluded products l the “conversion” of a basic class to a different schedule (i.e. II to a III, IV or V) Dispositions – Bulk Conversions Dispositions– Bulk Conversions Summary Summary Totals Confirmation Year End Report Procurement Selection Menu UN Psychotropic Substance Report Ø Specified psychotropic substances in UN Schedules III and IV, member countries voluntarily submit statistics to UN l Check the DEA Diversion web site (www.deadiversion.usdoj.gov) l Check the INCB web site (www.incb.org) l Check the “green list” - attached Ø Bulk and non-bulk manufacturers should report. Ø DEA attempted to codify a regulation which would have required such reporting (circa 1992), however never promulgated the rule. Year End Report Psychotropic Selection Menu Psychotropic Substances to be Reported 71 Schedule III: Ø Clotiazepam Ø Meprobamate Ø Mesocarb Ø Cloxazolaml Ø Methylphenobarbital Ø Buprenorphine Ø Delorazepam Ø Methyprylon Ø Butalbital Ø Ø Diazepam Midazolam Ø Cathine Ø Nimetazepam Ø Ø Cyclobarbital Diethylpropion Ø Nitrazepam Ø Flunitrazepam Ø Estazolam Ø Nordazepam Ø Pentazocine Ø Ethchlorvynol Ø Oxazepam Ø Ethinamate Ø Oxazolam 71 Schedule IV: Ø Ethyl loflazepate Ø Pemoline Ø Fencamfamin Ø Phendimetrazine Ø Allobarbital Ø Fenproporex Ø Phenobarbital Ø Ø Alprazolam Ø Fludiazepam Phentermine Ø Pinazepam Ø Barbital Ø Flurazepam Ø Pipradrol Ø Benzphetamine Ø Halazepam Ø Prazepam Ø Bromazepam Ø Haloxazolam Ø Ø Pyrovalerone Brotizolam Ø Ketazolam Ø Camazepam Ø Secbutabarbital Ø Loprazolam Ø Chlordiazepoxide Ø SPA (lefetamine) Ø Lorazepam Ø Clobazam Ø Temazepam Ø Lormetazepam Ø Clonazepam Ø Tetrazepam Ø Mazindol Ø Clorazepate Ø Triazolam Ø Medazepam Ø Vinylbital Ø Mefenorex Ø Zolpidem Psychotropic Report Questions? UN Reporting and Quota Section [email protected] (202) 307-7184 .