DEA Regulation Changes: Pharmaceutical Controlled Substances
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The document summarizes new regulations from the Drug Enforcement Administration (DEA) regarding the collection, destruction, and disposal of controlled substances. Key changes include allowing ultimate users and registrants to become authorized collectors, defining terms like "non-retrievable" and "pharmaceutical wastage," and consolidating disposal options. Institutions no longer need DEA approval for on-site destruction if they meet the non-retrievable standard. The new rules aim to make disposal more widespread, sustainable, and protect the environment by preventing flushing of controlled substances.
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DEA Regulation Changes: Pharmaceutical Controlled Substances
- 1. Pharmaceutical Controlled Substances Regulation Changes: What Do The New DEA Pharmaceutical Regulations Mean For Your Organization?
- 2. Meet Your Moderator: Sasha Laferte
- 3. 1. All lines are muted, use the chat panel for tech issues. 2. Unanswered questions will be answered on Twitter after the webinar. 3. Webinar recording and slides will be emailed to you tomorrow morning. Share With the Audience
- 4. Meet Your Presenter Mike Albert Onsite Support Services Manager, New England malbert@triumvirate.com www.linkedin.com/in/michaelalbert1 • Worked with Triumvirate for 6 ½ years • Worked mostly in the HealthCare Niche • Managed Healthcare onsite teams at large Healthcare Institutions • Healthcare Environmental Manager (HEM) • Sat in on and worked with multiple Environment of Care Committees
- 6. Drug Enforcement Administration (DEA) New final rule went into affect September 9th, 2014 On Controlled Substances (21 CFR Parts 1300, 1301, 1304 et al.) Disposal of Controlled Substances; Final Rule
- 7. Our Key Message Collection, Destruction and Removal of Controlled Substances, is now more protected, widespread and sustainable
- 8. Who Is This For? Ultimate End Users People who lawfully obtain Controlled Substances – Where and when can they dispose of unused/unwanted substances? Registrants Reverse Distribution the easiest way to dispose of controlled substances? Becoming a Collector for the community – Safety, security and cost of disposal. Waste/Disposal “No Dumping” Policies Burdened time and risk with too much documentation
- 9. How often do you worry about proper Controlled Substance handling and disposal at you institution? 1) Never 2) 1-2 times a month 3) 1-2 times a week 4) Daily 5) All the time
- 10. What Will You Learn? What is an ‘Ultimate User’ and ‘Non-Retrievable’? Understanding what registrants are capable of providing to the public. Required Paperwork and Documentation – New DEA Form 41 Knowing how to properly dispose of all controlled substances from your institution.
- 11. You Might Be Thinking... • Can I really destroy any controlled substance on my site? • Do all DEA agencies have to follow this regulation? • Is this the safe and responsible direction to go towards? • Does the cost out-way the benefit?
- 12. Benefits of Collection What Others Say If we become a Collector, we will have much more unwanted attention at our institution. Letters still need to be sent into the Special Agent in Charge (SAC), for authorization for destruction and disposal of controlled substances We should continue to waste our un- used or partially used controlled substances in to the sewer system – legal and cheap What the Regulation States Now A collector could have more unwanted attention from the community but controlled substances will be collected and taken out from illegal use. Letters do not have to be written to the SAC for approval of destruction. However, new practices will need to meet the new definition of Non- Retrievable If I were to collect and divert all controlled substances “pharmaceutical wastage” from the sewer system, we will be saving the environment and helping future drinking water be clean
- 13. Overview What Changed? Authorized Collector Destruction and Disposal Options
- 14. Our Key Message Collection, Destruction and Removal of Controlled Substances, is now more protected, widespread and sustainable
- 15. What Changed? What Changed? Authorized Collector Destruction and Disposal Options
- 16. Consolidation and Implementation of the Secure and Responsible Drug Disposal Act of 2010 http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf
- 17. New Definitions Ultimate End User Non-Retrievable
- 18. Limited disposal options leads to improper disposal solutions
- 19. Where Do The Drugs Go? www.whitehouse.gov/ondcp/disrupt-domestic-drug-trafficking-and-production
- 20. “the nonmedical use of prescription drugs is a growing problem in the United States” The Disposal Act
- 21. Options Before/After Changes Ultimate End User (Normal Patient) Take Back Day Take Back Day Transfer to a Authorized Collector Practitioner/Non- Practitioner Reverse Distribution Reverse Distribution “Sewering” Collection to meet ‘Non- Retrievable’ Definition for Disposal “Sewering” Need DEA Approval from SAC Do not need DEA approval
- 22. Authorized Collector What Changed? Authorized Collector Destruction and Disposal Options
- 23. Registrants can apply to become an Authorized Collector http://www.DEAdiversion.usdoj.gov.
- 24. Authorized Collector Need to Know Safety and Security In a Secure Area Locked Container with Inner Liner No Inventory Taken Labeled for only Schedule II - V Prompt Disposal Small Opening
- 25. Benefits of Collection? Possible Solution/Resolution Proper monitoring and a quick reference to the label on the container is a must Having the location of the container in an area where there is less traffic but more employees is key to make sure eyes are tuned in. The DEA have very ‘loose’ requirements to make sure that each institution can come up with their own solution What is Hard to Do Keep Schedule I’s out of the container Monitoring the Collection Container Meet all requirements for the collection container and inner liner
- 26. Disposal and Destruction Options What Changed? Authorized Collector Destruction and Disposal Options
- 27. Options for Disposal/Destruction • Take Back Days • Mail-Back Programs • Collection Drop Offs • Reverse Distribution • Onsite Destruction
- 28. Our Key Message Collection, Destruction and Removal of Controlled Substances, is now more protected, widespread and sustainable
- 29. Onsite Destruction 1) Don’t need special approval by the SAC. (Still need Form 41) 2) Need to meet Non-Retrievable requirements 3) Pharmaceutical Wastage now defined Controlled substance dispensed for immediate administration pursuant to an order for medication in an institutional setting remains under the custody and controlled of that registered institutions even if the substance is not fully exhausted (“drug wastage” & “pharmaceutical wastage”)
- 30. Container Ideas
- 31. New DEA Form 41 Sections: A) Registrant Information B) Items Destroyed 1) Inventory
- 32. New DEA Form 41 (cont.) Sections: 2) Collected Substances C) Method of Destruction D) Witnesses
- 33. “The DEA will not evaluate, review or approve the processes or methods utilized to render a controlled substance non- retrievable, as long as the desired result is achieved.” Disposal of Controlled Substances; Final Rule
- 34. Summary What Changed? Authorized Collector Destruction and Disposal Options
- 35. Action Plan Decide if you want to be collector and aide your community Get a Policy or Procedure in place to more effectively adhere to new innovative options for controlled substance destruction disposal Take advantage of the new regulations to get controlled substances out of our drinking water and Environment (Pharmaceutical Wastage)
- 37. Thank You For Attending! • You will receive an email tomorrow with a copy of this presentation • Please complete our short survey • Register for future webinars at http://www.triumvirate.co m/training/events • Expect a transcribed copy of the Q&A as well as a special offer.
Editor's Notes
- Lisa All lines are muted, use the chat panel for tech issues. Q&A at the end, tweet questions using #EventsRule Unanswered questions will be answered on Twitter after the webinar. Webinar recording and slides will be emailed to you tomorrow morning.
- Multiple revisions Took a long time to get to this point. Over 1.5 million registrants Considering time stamps, costs, other regulations Over 25 pages of questions and answers to the new regulation – great reference – most likely one of your questions after this is in there.
- Multiple revisions Took a long time to get to this point. Over 1.5 million registrants Considering time stamps, costs, other regulations Over 25 pages of questions and answers to the new regulation – great reference – most likely one of your questions after this is in there.
- More easier options for collection Less paperwork Options to help your community be safer Less regulation on how to get rid of it in some cases – becoming a collector – there are more specific rules to follow.
- Registrants: Retail pharmacies, hospitals/clinics, manufacturers, distributors, revers distributors and narcotic treatment centers, LTCF’s Check in with hospitals who bring/drop drugs off. - Some hospitals have already done this. https://www.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1 Regional – differences and different regulations/agencies Learning as they go Not all offices are up-to-speed on all new regulations
- Never – something not in your workplace OR you feel like it is completely under control 1-2 times a month – occasionally thinking about it when doing rounds and wondering how some substances are being handled 1-2 times a week – much more because of the rounding or questions being asked. Daily – normal occurance (pharmacist, head nurse, maybe doctor, manufacturer or other registrant) All the time – same as above Many registrants out there do not want to go to jail. (Research, Manufacturing, Reverse Distribution, Clinical) Do the right thing – environmentally Just another policy to review
- New terms! New ways to collect/offer to public New DEA form 41 – slightly different to account for newer regulations Destruction – new legal options. Innovative Options. Knowledge = power and power can equal safety
- Many questions, not all offices are up-to-speed on new regulation We are going to tell you the facts and let you all decide on what works best for each place. Unique settings.
- Focus on the positive impacts Less paper work, need for letters
- The Disposal Act amended the Controlled Substances Act (CSA) to give the DEA authority to publicize new regulations The new rule eliminates existing 21 C.F.R. 1307.12 and 1307.21, which outline requirements for registrant and non-registrant disposal, including return and recall. Allow ultimate users to deliver unused pharmaceutical controlled substances to appropriate entities for disposal in a safe and effective manner consistent with effective controls against diversion. The goal of the Disposal Act is to encourage public and private entities to develop a variety of methods of collection and disposal in a secure, convenient, and responsible manner.
- Ultimate End User – Person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household. Non-Retrievable - permanently alter the substance's physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. A substance is considered "non-retrievable" when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.
- Hard to only wait for yearly drug take back days. Narcotics would sit in cabinets for long time Gets into the hands of wrong entities More open market substances = Diversion
- From a riend or relative is 70% = #1 diversion method Less than 18% come from the doctor! Proper disposal = less diversion Innovative solutions to suite your needs and get it done properly.
- This was back in 2010 and still a problem today. Easily hidden, poorly policed and abused. Regulation can write something but everyone need to act to do there part to help diversion – why it was written
- Not going to go through entire slide You should fit into a group Practitioner (retail pharmacies and hospitals/clinics with on-site pharmacy) Non-Practitioner (manufacturers, distributor, reverse distributors, narcotic treatment centers) Middle Column is what were options before Far right, what can be done now Understand – DEA gave more options for better/proper disposal Even out here in MA it is difficult to still get a hold on all the regulations. There are over 60 different regional offices that are trying very hard to get on the same page with the new Federal regulation. Can always ask for assistance when needed.
- High level look at what it means to be an Authorized Collector
- Voluntary – don’t have to do it and don’t need to educate the public if you decide to do it. Goal: Ultimate Users will have more options…locations…for disposal Snapshot of what it looks like Amend your registration to meet requirements Do this BEFORE collecting
- Secure to a wall, floor (prevent moving and ‘diverting’) Locked Cont. w/ inner liner – special specifications for inner liner b/c it will be mailed back through a reverse distributor or picked up by the reverse distributor Small opening – keep out unwanted diversion and keep in the controlled substances (In but not out) II-IV ONLY! No inventory but inventory of mail back packages and inner liners Prompt Disposal – allow for flexibility but LTCF’s have 3 business days
- Added security risk Added cost – no money from the Gov’t – small cost? Large cost? Innovative solutions. No institution as of yet, has done this process.
- Reverse Distribution - Reverse distribute means to acquire controlled substances from another registrant or law enforcement for the purpose of return or destruction. Revision included security, inventory, recordkeeping, and other requirements and procedures pertinent to persons who reverse distribute. T Entities who reverse distribute must destroy controlled substances received for the purpose of destruction within 30 calendar days of receipt. Day 1 is the day the substances are physically acquired through pick-up or delivery.
- Options for disposal and destruction to remove diversion
- Most common in the research areas – before a longer process to get approval – now document and meet non-retrievable definition Non-Retrievable - permanently alter the substance's physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. Pharmaceutical Wastage - Controlled substance dispensed for immediate administration pursuant to an order for medication in an institutional setting remains under the custody and controlled of that registered institutions even if the substance is not fully exhausted (“drug wastage” & “pharmaceutical wastage”). Such remaining substance must be properly recorded, stored, and destroyed in accordance with DEA regulation Talk about VA Case study Multiple locations Small added cost Disposal of non-regulated waste Out of the sewer system
- Options out there. Safety and security Not for other narcotics – research, manufacturing, etc. Not all with work This is not a recommendation, different containers for different people.
- Use when completing destruction onsite with registrant – Research and manufacturing Registrant Information Items Destroyed 1) Inventory of substances to be destroyed
- A) Inventory of substances to be destroyed Where to identify inner liners from Authorized collection – remember not the inventory of substances themselves. C) What was used for onsite destruction (Meet Non-Retrievable) D) Sign off – employee’s of institution – first person recommended to be registrant if possible Pharmaceutical Wastage – do not need this form
- Even though it many take a while to get all regions on the same page, nothing needs to be approved – before. Meet the non-retrievable definition and good to go.
- Slight alterations to make the regs more viable and usable Authorized collector for community More options for disposal with easier options to use. – remember nothing set out by DEA for system – your own innovative system needed.
- 1 Study – reverse distribution high cost, implement into a existing waste stream Regional wastewater authorities multiple in each state Cannot remove the controlled substances Pollution Prevention authorities State Wastewater Authorities Department of Environmental Quality Department of Environmental Protection Bureau’s, authorities, divisions could start to regulate all of this because of what they can messure.