As part of the work that we do for the healthcare industry on pharmaceutical waste management, we track regulations related to controlled substances. On September 8, 2014 the US Department of Justice, Drug Enforcement Administration (DEA) issued a final rule on the disposal of controlled substances.
The final rule will become effective on October 9, 2014.
If your facility is registered with the DEA, or if you are simply an interested party, you should be aware of some of the questions answered by a new set of regulations. Some questions answered by a fact sheet for registrants include following:
- What is the disposal act?
- What do the implementing regulations do?
- Who is an “ultimate user”?
- What is “collection”?
- How can a registrant become an “authorized collector”?
- Who can operate a collection receptacle for the collection of pharmaceutical controlled substances?
- Who can operate a mail back program for the collection of pharmaceutical controlled substances?
- If I become an authorized collector and decide to stop, how do I do so?
- What can I collect as an authorized collector?
- Can ultimate users dispose of illicit drugs through a collection receptacle, mail-back package, or take-back event?
- I am a pharmacist. If my pharmacy chooses to become an authorized collector, will we need to collect and retain information about persons who utilize the collection receptacle such as a person’s name, prescription information, or physician information?
- How does a registrant dispose of controlled substances when 21 CFR 1307.21 is removed?
- How can a registrant destroy controlled substances?
In a September 9, 2014 letter to registrants from the US Department of Justice, aspects of the new regulations were outlined as follows:
- The new rule eliminates existing 21 CFR 1307.12 and 1307.21 and replaces it with 21 CFR Part 1317.
- DEA Form 41 must be used to record the destruction of all controlled substances. The form is available online at HTTP://www.DEAdiversion.USDOJ.GOV.
- DEA Form 106 must be used to report the theft or loss of any controlled substance.
- The rule implements a standard of destruction known as non-retrievable. A substance is considered non-retrievable when it can’t be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analog.
- The new rule also includes sections on reverse distributors, record-keeping, return and recall, two-person integrity requirement for transport and destruction, and memorandums of understanding.
Let me know if you need assistance with your pharmaceutical waste management program or if you have questions related to this new regulation. I can be reached at firstname.lastname@example.org or by telephone at 215 881 9401.