Pharmaceutical Training Seminar – 2016 Year-End Reports

UN Reporting and Quota Section ODE.Quota@dea.usdoj.gov

(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 • Individual registrant quotas (IQ,MQ,PQ)

l Monitoring the “80/20” NRM import rule l UN-treaty mandated reporting

ØProvides secure web-based database system ØPreloads your available drug codes,

historical data ØPerforms calculations ØGenerates error messages for possible

incorrect entries or when “specify” fields are not completed ØMoves submitted reports to completed list

Year-end Reporting Benefits

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

ØQuantities 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

Enter DEA issued user name & password

Secure website New Accounts: complete user agreement, print, sign,

& email to ODE Quota to receive corporate

administrator log-in

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

ØOnly material which was obtained against a quota should be reported under “Domestic Procurement” or “Manufactured/ Produced/ Synthesized/ Extracted”

ØMaterial acquired through authorized replacement of destroyed material is reported under “Other Acquisitions to be Accounted For”

Acquisitions

Year-end Reporting: Dispositions

ØMaterial acquired with current year’s quota ØMaterial 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 Buprenorphine Ø Butalbital Ø Cathine Ø Cyclobarbital Ø Flunitrazepam Ø Pentazocine 71 Schedule IV: Ø Allobarbital Ø Alprazolam Ø Barbital Ø Benzphetamine Ø Bromazepam Ø Brotizolam Ø Camazepam Ø Chlordiazepoxide Ø Clobazam Ø Clonazepam Ø Clorazepate

Ø Meprobamate Ø Mesocarb Ø Methylphenobarbital Ø Methyprylon Ø Midazolam Ø Nimetazepam Ø Nitrazepam Ø Nordazepam Ø Oxazepam Ø Oxazolam Ø Pemoline Ø Phendimetrazine Ø Phenobarbital Ø Phentermine Ø Pinazepam Ø Pipradrol Ø Prazepam Ø Pyrovalerone Ø Secbutabarbital Ø SPA (lefetamine) Ø Temazepam Ø Tetrazepam Ø Triazolam Ø Vinylbital Ø Zolpidem

Ø Clotiazepam Ø Cloxazolaml Ø Delorazepam Ø Diazepam Ø Diethylpropion Ø Estazolam Ø Ethchlorvynol Ø Ethinamate Ø Ethyl loflazepate Ø Fencamfamin Ø Fenproporex Ø Fludiazepam Ø Flurazepam Ø Halazepam Ø Haloxazolam Ø Ketazolam Ø Loprazolam Ø Lorazepam Ø Lormetazepam Ø Mazindol Ø Medazepam Ø Mefenorex

Psychotropic Report

Questions?

UN Reporting and Quota Section ODE.Quota@dea.usdoj.gov

(202) 307-7184