Response: The DEA selected methods for disposal that provide opportunities for ultimate users to securely, conveniently, and responsibly dispose of their unused, unwanted, and expired pharmaceutical controlled substances while also preventing diversion. These commenters suggested that the DEA allow the authorized collector to transfer collected substances in inner liners to a secure warehouse facility for storage until they can be picked up or shipped. [7] Issue: Several commenters asked the DEA to clarify whether or not controlled substances that were rendered “non-retrievable” will be regulated by the DEA. 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; for example, when a registrant or a registrant's employee initiates the destruction process by engaging a third-party destruction facility that will perform the actual destruction pursuant to § 1317.95(c). For reasons discussed in the NPRM, this final rule generally requires that, when authorized collectors choose to install collection receptacles, those collection receptacles must be placed inside their registered locations in the immediate proximity of a designated area where controlled substances are stored and at which an employee is present. 21 U.S.C. Nursing Home Intrusion: Not On Your Watch? The Compliance Officer will review, Healthcare Compliance Perspective - False Claims Settlement: [1] Issue: Several commenters asked the DEA to expand the definition of “law enforcement officer” to include law enforcement components of Federal agencies and civilian law enforcement officers. 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. This rule neither imposes requirements or regulations for the funding of disposal programs, nor imposes requirements or regulations regarding fees that registrants may charge to operate disposal programs. If discrepancies are identified during the reconciliation, the pharmacist and the facility develop and implement recommendations for resolving them, and make referrals to law enforcement agencies as appropriate. The DEA estimates the highest cost in any given year occurs in the first year, ranging from $45,282,242 to $99,075,339. August 2017 The DEA believes that such instances as described by the commenter will be incidental to testing. The Attorney General delegated responsibility for promulgating the Disposal Act implementing regulations to the DEA.[5]. 802(10). If necessary, the DEA may consider revising the requirements applicable to reverse distributors' destruction activities, or imposing additional security requirements. Compliance Officers must focus on ensuring that products, Healthcare Compliance Perspective: 9. The Administrator, in accordance with the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 21 CFR 1317.65. headings within the legal text of Federal Register documents. on NARA's archives.gov. Thus, for example, as discussed in response to issue [7] below, when a LTCF resident is transferred to another facility, the resident “has resided” at the LTCF, and the LTCF may dispose of the former resident's pharmaceutical controlled substances in an authorized collection receptacle. First, the DEA is permitting authorized hospitals/clinics and retail pharmacies to store inner liners that have been sealed upon removal from a collection receptacle at LTCFs in a securely locked, substantially constructed cabinet or a securely locked room with controlled access for up to three business days until the liners can be transferred for destruction. 21 CFR 1317.75. b. maintain accurate public health statistics. Part of the purpose in authorizing only certain hospitals/clinics and retail pharmacies to install and maintain collection receptacles at LTCFs is to ensure that a responsible registrant under the regulatory authority of the DEA is charged with ensuring the secure and responsible collection of pharmaceutical controlled substances at LTCFs. A 2014 DEA Ruling, The Disposal Act amended the Controlled Substances Act to give more options for proper disposal of medications in hospitals. [6] Issue: One commenter asked the DEA to allow a LTCF resident, or the resident's legal representative, to dispose of controlled substances through all available means, whether the resident is alive or deceased. The DEA believes that these two provisions will provide ultimate users and others with convenient options to safely and securely dispose of unused controlled substances. The DEA's rationale for Start Printed Page 53535allowing collection at authorized retail pharmacies was described in the NPRM. Response: The DEA does not distinguish between different “types” of reverse distributors. The commenter indicated that the word seems open for interpretation. 821, 822(d), 871(b), unless otherwise noted. The implementing regulations may not require any person to establish or operate a delivery or disposal program. (f) Except at a narcotic treatment program, the small opening in the outer container of the collection receptacle shall be locked or made otherwise inaccessible to the public when an employee is not present (e.g., when the pharmacy is closed), or when the collection receptacle is not being regularly monitored by long-term care facility employees. Therefore, in each instance in which the rule uses the word “timely” to refer to destruction requirements for reverse distributors, it refers to the specific time period (14 days in the proposed rule, 30 days in the final rule) in which reverse distributors are required to destroy controlled substances. Knowingly making false statements and, Healthcare Compliance Perspective - Healthcare Fraud: Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities. Response: The final rule does not require any specific language, design, or color choice for the display on the collection receptacle as long as the sign indicates that only schedules II-V controlled substances and non-controlled substances are acceptable. 21 CFR 1317.75. [1] Issue: One commenter asked the DEA to clarify whether or not the recordkeeping requirements in the rule apply to all registrants or only authorized collectors. One commenter stated that law enforcement officers' presence should be optional if there is a collection receptacle at the event that meets the specifications in the rule. [2] Issue: Eighteen commenters asked the DEA to permit hospitals to become authorized collectors so that they may maintain collection receptacles. Controlled Substance Disposal in Hospitals. Clin. This modification allows greater flexibility for collectors authorized to maintain collection receptacles at LTCFs. The Compliance Officer should evaluate the, Healthcare Compliance Perspective - Retaliation Suit: The destruction, Proper advance preparation for the care of older adults in, At least 25 percent of all businesses that close due, Healthcare Compliance Perspective: [5] Issue: Commenters asked the DEA to clarify who is responsible for tracking the mail-back packages, and how mail-back packages that were disseminated but not returned to the authorized collector will be reconciled with the inventory. Although this change may impact current business practices, as discussed in the NPRM, nationwide consistency is necessary in the disposal pharmaceutical controlled substances. These commenters stated that the DEA should treat civilian law enforcement officers as “authorized employees” for the purposes of this rule. In order to maintain this system, all collected substances must be handled in the manner described in this rule, including the requirement that the handling of a collection receptacle inner liner be restricted to employees of the authorized collector as provided, with the limited exception for LTCFs. The Compliance Officer should review with, Compliance Perspective: Limiting the supply of controlled substances. The DEA last modified the registration fees on April 16, 2012. In § 1301.75, redesignate paragraphs (c) and (d) as paragraphs (d) and (e) and add a new paragraph (c) to read as follows: (c) Sealed mail-back packages and inner liners collected in accordance with part 1317 of this chapter shall only be stored at the registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access, except as authorized by § 1317.80(d). [3] Issue: One commenter suggested that the DEA eliminate ARCOS reporting requirements for reverse distributors regarding collected substances from ultimate users. However, as previously discussed, this final rule expands the NPRM requirement and authorizes practitioners to store collected substances at their registered location in either a securely locked, substantially constructed cabinet or a securely locked room with controlled access. The DEA estimates that the average time per response will be 30 minutes and that the total annual burden will be 43,868 hours, with an estimated total annual cost burden of $928,247. 21 U.S.C. If an authorized collector stops collection activities, he/she must modify his/her registration to indicate such. [1] Issue: Eighteen commenters with experience operating a disposal program stated that following the new regulations will be prohibitively costly, and their current program will be forced to stop collection activities. Drug Take Back Programs. The title and introductory text in § 1304.22 were updated to accurately reflect their contents. The DEA understands that there may be circumstances where there is no authorized person to dispose of the controlled substances, such as when controlled substances are abandoned at a school or summer camp, and return to the ultimate user is not feasible. (b) Transport to a registered location. Handling of controlled substances is an important topic as well. “Authorized employee” did not pertain to law enforcement officers or to take-back events. [2] Issue: One commenter indicated that §§ 1317.15 and 1317.95 may conflict in that § 1317.15 allows for storage by a reverse distributor while § 1317.95 does not. Response: If an authorized collector or other entity wishes to conduct a take-back event, the event must be held in partnership with law enforcement, as provided in the rule. These commenters stated that stockpiling would increase diversion risks and would be a liability for the LTCF. Bruising was present, Last August, a woman with Alzheimer’s disease was reported missing, Healthcare Compliance Perspective: 1317.75 for two purposes incentive for collectors authorized to be collectors reverse distributor authorized... A pharmacy stores bulk drugs in the NPRM, and in accordance with 21 CFR 1317.75 ( )! 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