1 / 10

Controlled Substances Program

Controlled Substances Program. Controlled Substances Schedule I-V based on the propensity for addiction. Requires a DEA registration Specific inventory requirements, background checks and maintenance of files. Listed Substance

geoffreyd
Download Presentation

Controlled Substances Program

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Controlled Substances Program Controlled Substances • Schedule I-V based on the propensity for addiction. • Requires a DEA registration • Specific inventory requirements, background checks and maintenance of files. Listed Substance • List I or List II based on the importance in manufacturing of controlled substances • No registration necessary for research use. • Established thresholds for some items, no thresholds for others. California Precursors • Includes Federal List and more.

  2. Controlled Substances Program • Program Development objective: Establish automatic processes where possible. Minimize unnecessary impact on researcher. • Assumptions: People ordering controlled substances don’t know that they are ordering a controlled substance. • Requirements analysis – 21 CFR 1300 – 1310, DOE Order 580.1A, and UC BUS 50 is completed • Benchmarking is completed • Process development is almost completed. • Policy documents are in development. • Communications Plan is in development. • Implementation Plan is in development.

  3. Controlled Substances – User Group LSD – Scott Taylor, Nina Hahn PBD/JBEI – Tim Lease, Henrik Scheller, Ellen Ford Procurement – Shanna Wells Protective Services – Brian Strock Property – Cynthia Lytle/Brian More´ Supplier – Ken Blackwell (GSS) Facilities Receiving – Tim Montoya/Jon Cleveland

  4. Controlled Substances Requirements21CFR1300-1308

  5. Controlled Substances - Recommendations

  6. Controlled Substances - Benchmarking Benchmarked institutions: PNNL, LLNL, several UCs, SLAC, Sandia - Livermore Results: Some required the PI to be registered with DEA vs the institution Half didn’t do background checks All required and internal “registration” and training Most identified the use of controlled substances through experiment reviews, protocol reviews, chemical ordering systems, or hazard reviews.

  7. Listed Substances • Listed substances with thresholds for single transactions.

  8. Listed Substances • Listed substances with thresholds for single transactions.

  9. Listed Substances No thresholds • Ephedrine and Pseudoephedrine, salts, optical isomers and salts of optical isomers • Ergocristine and its salts • Gamma Butyrolactone (GBL) • Hypophosphorous acid and salts • Iodine (elemental crystals, >2.2% solution) • N-phenyl-4-piperidone (NPP) • Phenylpropanolamine, salts, optical isomers and salts of optical isomers • Red and white (yellow) phosphorus

  10. Questions? How do you want this program communicated?

More Related