Post Webinar Q&A
How do I waste my controlled meds that I don't use or are expired?
Expired controlled substances in inventory are different than operational controlled substances waste leftover from patient administration. Expired controlled substances do not get “wasted” on-site and need to undergo final destruction via reverse distribution.A few things of note:
- DEA registrations are issued according to the type of controlled substances activities that a registrant is authorized by the DEA to conduct.
- “Reverse distribution” is a specific type of DEA registration for conducting controlled substances destruction activities, which differ from a DEA practitioner or hospital/clinic type of registration.
- The only form of final destruction that the DEA currently recognizes is incineration, which is what DEA-registered reverse distributors use to conduct controlled substances destruction on behalf of other registrants.
- DEA practitioner and hospital/clinic registrants generally send expired controlled substances to a DEA-registered reverse distributor to conduct final destruction on their behalf, and the reverse distributor then provides them an official Certificate of Destruction which must be maintained with required DEA records as proof that destruction took place.
Per 21 CFR 1317.05(a)(5), if a facility wants to conduct on-site expired controlled substance destruction/disposal ongoing, they must contact the Special Agent in Charge at their local DEA Office in writing requesting permission to do so and obtain approval before proceeding: In the event that a practitioner is required regularly to dispose of controlled substances,the Special Agent in Charge may authorize the practitioner to dispose of such substances, in accordance withsubparagraph (a)(4)of this section,without prior application in each instance, on the condition that the practitioner keep records of such disposals and file periodic reports with the Special Agent in Charge summarizing the disposals. The Special Agent in Charge may place such conditions as he/she deems proper on practitioner procedures regarding the disposal of controlled substances.If expired controlled substances are being destroyed on-site without having a DEA reverse distribution registration to conduct destruction activities or prior written approval from the DEA granting authorization to conduct on-site destruction, doing so is conducting controlled substance activities outside of approved activities according to the type of DEA registration held.
Click here to view: 21 CFR Part 1317 (Disposal)
Click here to view: 21 CFR Part 1317 (Subpart C)
Can I store my expired controlled drugs in the matrix drawer until I get rid of them?
If expired controlled substances are separated out from non-expired controlled substances and all other medications in secure storage, a matrix drawer could be used. Remember that any expired schedule II controlled substances must also be separated out from expired schedule III-V controlled substances within storage.
Can I return controlled drug pills to stock if the owner doesn't pick them up?
No. After a controlled substance has been dispensed it cannot be returned to inventory and must be wasted into a drug deactivation system to render it “non-retrievable” per 21 CFR 1300.05.
How do I know if I need to submit PMP reports?
PMP requirements vary depending on where you practice and can range significantly in terms of requirements for registering, querying, consulting and reporting based on where you are located (some states exemption veterinarians from PMP use entirely).Start by looking up PMP requirements based on the state/jurisdiction where you practice. Keep in mind that your capacity as a veterinarian and whether or not you are in-house dispensing controlled substances are factors that may be considered for whether or not your state/jurisdiction requires you to use the PMP.
If I am the witnessing veterinarian and I am in a procedure is there anything preventing me from signing witnessing signature after I am completed because I cannot afford to scrub out then back in just so someone can distribute meds as long as my team shows me what they administered? Witnessing means actually witnessing. If you don’t actually observe the procedure, you did not witness it. Can you wait until after you are done with a procedure to witness it? In most cases, witnessing is not life or death. Surgery is.
How do I know if I need to submit PMP reports?
PMP requirements vary depending on where you practice and can range significantly in terms of requirements for registering, querying, consulting and reporting based on where you are located (some states exemption veterinarians from PMP use entirely).
Start by looking up PMP requirements based on the state/jurisdiction where you practice. Keep in mind that your capacity as a veterinarian and whether or not you are in-house dispensing controlled substances are factors that may be considered for whether or not your state/jurisdiction requires you to use the PMP.
If I am the witnessing veterinarian and I am in a procedure is there anything preventing me from signing witnessing signature after I am completed because I cannot afford to scrub out then back in just so someone can distribute meds as long as my team shows me what they administered?
Witnessing means actually witnessing. If you don’t actually observe the procedure, you did not witness it.
Can you wait until after you are done with a procedure to witness it?
In most cases, witnessing is not life or death. Surgery is.
