pharmaceutical training seminar – 2016 online quota ......pharmaceutical training seminar – 2016...
TRANSCRIPT
Pharmaceutical Training Seminar – 2016 Online Quota Applications
UN Reporting and Quota Section [email protected]
(202) 307-7184
Why the Switch from Paper? ØOMB requested we go paperless by 2013
Ø Benefits
• Provides secure web-based database system • Verifies registration as active and current • Preloads your available drug codes, historical data • Performs calculations • Provides confirmation of receipt and status • Expedites process
21 CFR 1303 & 1315 Compliance Ø Procurement applications due by April 1
Ø Import applications due by April 1
ØManufacturing applications due by May 1 Ø Adjustments to any quota can be requested
throughout the year
ØQuantities should expressed as: l Anhydrous acid, base or alkaloid l GRAMS
Accessing Quota Applications www.deadiversion.usdoj.gov
Reporting
Quotas
Quota Applications
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
‘71 Convention Compliance
Must request specific isomers for:
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
Online Quota Application “For Sale” vs. “For Conversion”
• Codeine • D-Amphetamine • D-Methamphetamine • Diphenoxylate • Hydrocodone • Morphine • Noroxymorphone • Oxycodone • Oxymorphone
Online Quota Application 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
Procurement Quota Application
Quota Allotment Categories
Quota Allotment Categories ØCommercial Manufacturing
• Conversion to other substances • Dosage form
ØProduct Development • All stages leading to FDA approval
l Laboratory scale l Scale up l Exhibit l Stability
Quota Allotment Categories
ØPackaging • Packaging/Repackaging • Labeling/Relabeling
ØReplacement • Case-by-case basis for commercial mfg
ØTransfer • Bulk API • In-process material • Finished dosage units
Quota Allotment Categories
Commercial – Conversions
Commercial - Dosage Forms
Product Development
Labeling & Packaging
Replacement
Transfer
Summary
Summary
Status Report
Quota Amendments
List 1 Import quota
List 1 Import quota
List 1 Import quota
