Suspicious Orders of Controlled Substances
2020-12-02 2021-03-31 2021-03-31 2020-12-02 2020-12-02 2021-03-31 2021-03-31 2021-03-31
DEA-2021-0003-0021 DEA-2021-0003-0035 DEA-2021-0003-0038 DEA-2021-0003-0004 DEA-2021-0003-0025 DEA-2021-0003-0033 DEA-2021-0003-0036 DEA-2021-0003-0039
05:00:00 04:00:00 04:00:00 05:00:00 05:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/DEA-2021-0003-0021 https://api.regulations.gov/v4/comments/DEA-2021-0003-0035 https://api.regulations.gov/v4/comments/DEA-2021-0003-0038 https://api.regulations.gov/v4/comments/DEA-2021-0003-0004 https://api.regulations.gov/v4/comments/DEA-2021-0003-0025 https://api.regulations.gov/v4/comments/DEA-2021-0003-0033 https://api.regulations.gov/v4/comments/DEA-2021-0003-0036 https://api.regulations.gov/v4/comments/DEA-2021-0003-0039
Rungsun Andres Anonymous Sophia Maggie Anonymous Anonymous Anonymous
Gunkoom Oliver Anonymous To B Anonymous Anonymous Anonymous
Thank you for allBest RegardsMr.Rungsun Gunkoom I am writing to express my support for the DEAs implementation of 21 CFR Section 1300-1301. As is the PDDA already requires that distributors of controlled substances make an effort to investigate, report and maintain record of any suspicious orders. The addition of the two-option system of reporting in 21 CFR  1301.78 would make the procedure for dealing with suspicious orders much clearer registrants while leaving them with leeway to deal with orders they are able to clear of suspicious circumstances as long as they maintain records on the due diligence that cleared the order. Additionally, according to the DEAs own findings this regulation would eliminate a grey area in reporting which has allowed registrants to neglect maintaining proper records of due diligence, and in some cases report suspicious orders after they have already been filled.While there might be some concern that this regulation would impose additional costs upon registrant firms the proposed rule complies with the RFA and will actually end up saving registrants an estimated total of $2,931,000 via the use of the ARCOS Distributor Tool which was developed to ease the cost of due diligence on registrants as well as the use of the DEAs central database for reporting suspicious orders.  Overall, there is little reason to not pass what is functionally a standardization of reporting procedures in a wider legislative effort to stem the abuse of controlled substances. Pharma Logistics agrees with and supports excluding reverse distributors from the proposed rule. However, based on review of regulatory text in 1301.74(b)(3), we believe that the following statement may be written incorrectly:orders placed by registrants to DEA registered reverse distributors requesting the return ordestruction of controlled substances, are not distributions subject to the provisions of this part.Pharma Logistics formally requests the DEA to reword this statement to read as follows:orders placed by DEA registered reverse distributors to registrants RIN 1117-AB47/Docket No. DEA-437Personally, this is very important as suspicious substances need to be better monitored. The Drug Enforcement Management should not be the only one to be participating this. There should be multiple collaborations in order to strengthen reals regarding suspicious substances. In addition, not just drugs should be monitored but also suspicious objects like seeds such as what we see spreading across the United States with mystery seeds sent from China with no return address. In order to keep the people safe, regulations needs to be strengthen in order for this to be successful.  This is a great way to fight the opioid epidemic. Making sure that orders are monitored for suspicious activity will help to nip problems in the butt before they start,  As a licensed healthcare practitioner, I think it is thoughtful to specifically include the questions pertinent to another agencys investigation of the content of an order received under suspicious circumstances (ORUSC) report at the initial instance the busy practitioner or technician is able to provide the associated details. However, in my experience, while electronic submissions are generally fast when functioning correctly, I recall several occasions this past year where downed powerlines from heavy storms or tornadoes, electrical fires, and rolling power outages prevented the computer systems from accurately submitting any documentation or receiving electronic prescription submissions. During such unfortunate circumstances, should an ORUSC take place, it would help to provide a PDF downloadable option or a paper form submission for a pharmacist or technicians to keep on hand in the pharmacy in advance in case an unusual request is placed at a time when the electricity or wireless connections are not functioning properly. In addition, for health care professionals that may have to submit such reports on the go, having a version of this submission form easily accessible from a tablet or mobile device is highly desirable, especially for EMTs or pharmacy support staff with a printable or PDF downloadable option to keep in the pharmacy for the required two year time duration. At times certain employees may be too busy to check e-mails during the workday, but the ease of submission and the seven-day window to verify details and the suspicious nature of the ORUSC are extremely helpful when trying to determine the severity of the suspicious activity and how to handle the circumstances documented in the report. My only concern is that if a report were indeed suspicious, the seven-day window would need to ensure that if a report was filed by a diligent healthcare practitioner or other support staff, that another worker implicated in possible drug diversion would not be able to readily interfere and close the otherwise valid investigation to avert suspicion. I hope that the seven-day time frame will encourage all parties to do their part in sorting out the issue in a timely, productive manner to improve pharmaceutical practice. Regarding RIN 1117-AB47/Docket No. DEA-437,The efforts to regulate suspicious orders of controlled substances, as well as clarifying the procedures a registrant must follow when suspicious orders have been received, are exceptional tactics in mitigating the act of drug diversion. This proposed rule is valuable to the welfare of the country as it battles an ongoing opioid epidemic. Furthermore, the two-option blueprint of record-keeping makes for an effective database. Along with others, I agree that a revision to the amount of time designated to scrutinizing documents may be necessary for eventual research purposes, though there may only need to be an extension of about two or three years onto the initially-proposed duration. As pointed out by a previous commenter, medical records are kept for seven years, so the current two-year maximum of this DEA proposal seems a bit underestimated. Besides this area, the overall strategy of documentation should provide for better tracking application and the prevention of substance abuse. Thank you for your consideration on this matter. United Veterinary Services Association (UVSA) Comments Docket No. DEA-437