Disposal of Controlled Substances
From the article:
[10] Issue: One commentor asked the DEA to clarify the phrase “causes the destruction” as it could be interpreted to mean any person involved in the process.
Response: As previously discussed, proposed § 1317.100 is relocated in this final rule to § 1304.21(e). The DEA included the term “causes the destruction” to encompass such circumstances where a registrant does not itself destroy the controlled substance but is still responsible for the destruction;
also: [another example of DEA’s vague answers when asked for guidance, how comforting]
12] Issue: One commenter noted that the DEA used inconsistent time requirements throughout the proposed rule, such as “timely,” “prompt,” and “as soon as practicable, but no later than 14 days.” Additionally, several commenters requested clarification regarding the definition of the word “prompt” in the proposed rule, and commenters asked for clarification regarding how the DEA would determine whether an action is “prompt.” Commenters asked for guidance as to what time range the DEA would find reasonably acceptable.
Response: The DEA’s use of different time standards throughout the proposed rule was intentional as the different circumstances of each requirement warrant different standards. The various timing requirements are intended to be flexible enough to account for individual circumstances while also ensuring sufficient and adequate controls to prevent diversion and opportunities for diversion. The DEA considered imposing specific timelines (e.g., three days, five days); however, the wide variety of business models and activities made it impossible in most circumstances to set a specific deadline that would prevent diversion and diversion opportunities. Additionally, violations of specific timelines would be per se violations of the regulations, whereas violations of the flexible “prompt” and “as soon as practicable” standards would be considered under each registrant’s individual circumstances. The DEA’s determination will be guided by whether the registrant has fulfilled its responsibility to provide effective controls and procedures to guard against theft and diversion. 
There are many more potential hangups and such with issues like storing/collecting meds until ready to send out for ‘destruction’. Questions about shipping all done through USPS who unlike recent, hesitant drug warriors UPS and FEDEX, they are NOT able to inspect/search a package w/out a warrant.
How wonderful of the DEA to give us the opportunity to take on another “free task” and having to account for these controls and their destruction.
Filed under: General Problems
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