It is important to note that this rule provides additional options for disposal and does not prohibit any methods currently used by LTCFs that are consistent with Federal, State, tribal, and local laws and regulations. Response: The final rule definition is expanded from the proposed rule to specifically include officers of the law enforcement components of Federal agencies, and police officers of the Veterans Health Administration and the Department of Defense. However, the DEA believes that the DOT's Hazardous Materials Regulations apply to entities that place hazardous materials in commercial transportation, and not government vehicles operated by government personnel solely for non-commercial purposes. on (f) Any registrant that has been authorized as a collector and desires to discontinue its collection of controlled substances from ultimate users shall notify the Administration of its intent by submitting a written notification to the Registration Unit, Drug Enforcement Administration. documents in the last year, 1047 [4] Issue: One commenter asked the DEA to permit entities other than law enforcement to conduct take-back events. The economic impact of the mandatory portion and voluntary participation aspects of this rule is estimated to be significant, greater than one percent of annual revenue, for two (5%) of 38 affected small businesses. One commenter asked for clarification on an authorized collector's liability should a receptacle become subject to diversion or if improper substances are deposited. The Administrator, in accordance with the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. Healthcare Compliance Perspective: This is because all handling, monitoring, security, recordkeeping, and witnessing with regard to the pharmaceutical controlled substances is performed or supervised by registrants. [7] Issue: Several commenters urged the DEA to create a new status that permits non-registrant organizations to become authorized collectors for the sole purpose of collecting controlled substances from ultimate users and others authorized to dispose of controlled substances on behalf of ultimate users. It may be true that mail-back packages originating in some rural areas may be subject to an increased risk of diversion due to fewer people being able to readily witness theft from a mailbox. (3) When discontinuing activities as a collector or ceasing an authorized mail-back program: (i) Make a reasonable effort to notify the public prior to discontinuing such activities or ceasing the authorized mail-back program; and. These specific security measures are designed to help prevent and reduce the opportunities for diversion (including the re-introduction of tainted pharmaceutical controlled substances into the stream of commerce). [7] Issue: Some commenters asked the DEA to clarify the meaning of the terms “regularly” and “practitioner” used in the proposed § 1317.05(a)(4). An effective Compliance and Ethics Program requires a, By ShirleyAnn Janulewicz RN, BSN, PHN (c) Any controlled substances collected by law enforcement through a take-back event, mail-back program, or collection receptacle should be stored in a manner that prevents the diversion of controlled substances and is consistent with that agency's standard procedures for storing illicit controlled substances. (c) Each take-back event should have at least one receptacle for the collection of controlled substances. Response: The DEA declines to define this term for the purpose of this rule. Given that bed rails fall under the category of restraints, Healthcare Compliance Perspective - Medicaid Claims: Not all registrants are eligible to become authorized collectors. Response: As previously discussed, the DEA believes that all of the inventory and recordkeeping requirements in part 1304 are the minimum necessary to ensure accountability and identify diversion. Persons required to keep records and file reports. This commenter stated that such installations will be burdensome and will discourage participation for these programs. A certified nursing assistant had been working at, Anthony Enrico, a Passaic County Podiatrist, was sentenced to three, A nurse gave a resident her insulin injection and accidentally, Healthcare Compliance Perspective: One commenter asked whether or not physician-owners will be considered authorized employees. The Compliance Officer will review the policies and, Healthcare Compliance Perspective - Death of  a Resident: In addition, the title of § 1304.33 has been changed to add clarity, and the acronym “ARCOS” is clearly spelled out. documents in the last year, 72 [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. 1. documents in the last year, 9 [7] Issue: One commenter stated that the collection receptacle design specifications will require current collection programs for non-controlled substances to install new collection receptacles if those programs wish to additionally collect pharmaceutical controlled substances. Collectors that are authorized to conduct mail-back programs must have and utilize an on-site method of destruction, pursuant to 21 CFR 1317.05(c)(1). The Attorney General's delegation of authority to the DEA may be found at 28 CFR 0.100. Response: As discussed in the NPRM, an on-site method of destruction for mail-back packages is the minimum necessary to prevent diversion of controlled substances destined for destruction. [17] Issue: One commenter expressed concern that the DEA's assumption that controlled substances in LTCFs have been dispensed to, and are thus the property of, a resident may result in the reluctance of LTCFs to use automated dispensing systems to dispense to an ultimate user as needed. To this end, the DEA found that in order to properly address the disposal of controlled substances by ultimate users, it was necessary to conduct a comprehensive review of DEA policies and regulations related to each element of the disposal process, including the transfer, delivery, collection, destruction, return, and recall of controlled substances, by both registrants and non-registrants (i.e., ultimate users). The records that registrants are required to maintain pursuant to law are a vital component of the DEA's enforcement and control responsibilities—such records alert the DEA to problems of diversion and ensure that the system of controlled substances distribution is open only to legitimate handlers of such substances. Worthless services coupled with intentionally falsified documentation lead, Healthcare Compliance Perspective: As previously discussed, the second modification to this section allows certain LTCF employees, as designated by the collector authorized to maintain a collection receptacle at that LTCF, to install, seal, remove, store, and transfer for destruction the inner liners of the collection receptacle along with an employee of the collector. The DEA encourages entities that are not registrants to partner with authorized collectors or law enforcement. 21 CFR part 1304. The Compliance Officer needs to, Compliance Perspective: These commenters proposed that the collection receptacle be designed in such a way that it can be returned to the reverse distributor as a complete unit. In the context of this issue, the two-employee requirement only applies to installation and removal of the inner liners which does not need to be accomplished by two employees on the same shift. Additionally, a small number of manufacturers and distributors are estimated to volunteer to operate collection receptacles at their registered locations primarily for use by their employees. This allowance did not extend to other persons who are simply attending to a person who is resident of the LTCF. As explained above under “Compliance Date,” this final rule supersedes all existing MOAs and MOUs that registrants may have pursuant to § 1307.21, including MOAs and MOUs pertinent to storage of controlled substances. As previously discussed, the DEA is also allowing entities registered as hospitals/clinics with an on-site pharmacy to be collectors. Also, the DEA acknowledges that many pharmaceuticals that are recognized as acute hazardous waste (e.g., blood thinners) are non-controlled substances. The controlled substance license number of the facility/program or individual must be current Provide email address and fax number for the Class 3A facility Describe the proposed method of disposal/destruction. The DEA cannot readily foresee a circumstance where a short break in use as a result of illness, short-term hospitalization, or a trial dosage reduction would be considered a discontinuation of use. The requirement that the receptacle be “regularly monitored” is designed to prevent diversion opportunities, and to ensure that diversion would be detected as soon as possible. Effective Date: This rule is effective October 9, 2014. What is the proper way of documenting part-fills for controlled drugs and substances (including narcotics)? The performance standard is that the method renders the substance so that it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. Thus, ultimate users will be able to carry their unwanted pharmaceutical controlled substances to an authorized retail pharmacy or other authorized collector location and deposit those controlled substances in a secure container for disposal. This modification allows greater flexibility for collectors authorized to maintain collection receptacles at LTCFs. better and aid in comparing the online edition to the print edition. [2] Issue: Twenty commenters asked the DEA to include the language regarding sewering and landfill disposal in the text of the regulation. As echoed in the comments, the DEA remains concerned about the security risks of hospital/clinic and retail pharmacy employees transporting large quantities of collected substances, making them potential targets for drug seekers. Further reading Annex I: Disposal by incineration. As such, the modified regulations regarding registrant disposal codify existing practice, expand available options, and implement consistent procedures among registrants in accordance with their authorized business activities. The term collector means a registered manufacturer, distributor, reverse distributor, narcotic treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy that is authorized under this chapter to so receive a controlled substance for the purpose of destruction. [10] Issue: One commenter asked the DEA to clarify whether authorized collectors operating mail-back programs may use carrier services that allow packages to be held at a carrier facility until the packages can be picked up. 21 U.S.C. Compliance Perspective: False claims and billing fraud may, The best way an institution can avoid damaging sexual discrimination, Healthcare Compliance Perspective: The commenters asked for clarification regarding such transfers and transfers to a person lawfully entitled to dispose of an ultimate user decedent's property. Skilled nursing facilities are required to provide adequate, By: Louise Lindsey, B.S., M.A., D.Div. L. 111-273, 124 Stat. 2. This rule also reorganizes and consolidates previously existing regulations on disposal, including the role of reverse distributors. Preventing Abuse and Fraud with Antibiotic Stewardship Programs Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. The proper method of destroying a controlled substance that needs to be disposed of "disposed of or wasted" is to flush it down the toilet as advised by the manufacturer The penalty for violation of the Controlled Substances Act is For example, the general public typically enters retail pharmacies for short durations in order to conduct retail business and retail pharmacies generally have open, clearly observable common areas with little opportunity to conceal an unlawful purpose. The penalty for violation of the controlled substances act is. Municipalities or other organizations may partner with law enforcement as long as such events are conducted in accordance with all applicable laws and regulations pertaining to the disposal of pharmaceutical controlled substances. Depending on a variety of factors, including State authority and authorized business practices, some entities that dispense controlled substances may be registered with the DEA as either a retail pharmacy or a hospital/clinic. Any person who meets the criteria for “employee” and “law enforcement officer” outlined in the final rule will be a qualified officer for the purposes of disposal of pharmaceutical controlled substances, regardless of whether the person is considered a “civilian” law enforcement officer. [14] Issue: One commenter asked the DEA to clarify whether or not the 14-day destruction requirement applies to law enforcement. This required deleting the existing regulations at § 1307.21 which authorized the SACs to individually authorize disposal. 21 U.S.C. On-site means located on or at the physical premises of the registrant's registered location. These commenters stated that collection receptacles located inside of hospitals would provide ultimate users with an opportunity to dispose of medication that may no longer be needed or may be expired. [18] Issue: One commenter stated that the DEA did not consider veterinary practices, prisons, or clinics when calculating the economic impact analysis. Response: The DEA is modifying the final rule in §§ 1317.70(b) and 1317.75(b) to clearly indicate that comingling of controlled and non-controlled substances is permitted but not required. Schedule I controlled substances, by definition, have no accepted medical use in treatment in the United States, and may not be lawfully prescribed or otherwise distributed to any person. 21 CFR 1317.40. Upon completion of this course, the healthcare provider should be able to: • Describe the five schedules of controlled substances and provide examples for each schedule. [1] Issue: Thirteen commenters stated that the on-site destruction requirement for mail-back programs is severely Start Printed Page 53536limiting due to the limited number of commercial incinerators. Therefore, there is no basis to relax the requirements for reverse distributors whose activities are limited solely to the collection of pharmaceutical controlled substances for the purpose of disposal. Another commenter asked the DEA to clarify what information is required for ARCOS reporting. Only official editions of the These regulations contain specific language allowing law enforcement to voluntarily continue to conduct take-back events, administer mail-back programs, and maintain collection receptacles. 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. Destruction of controlled substances must be consistent with Federal, State, tribal and local laws and regulations. (b) Non-practitioner inventory. The requirement that collection receptacles be securely fastened to a permanent structure applies to all authorized collectors' collection receptacles, no matter the location of the registrant. recent, Alleged Sexual Abuse in Nursing Dangerous drugs may be destroyed provided the following conditions are met. (c) Collected controlled substances. [2] Issue: The DEA received a number of comments regarding the lack of provisions for hospice and other homecare programs to dispose of controlled substances on behalf of patients. In light of growing concern, To be honest, when I first thought of biometrics, images, An HIV-positive patient asked an office manager to fax his, Healthcare Compliance Perspective - Healthcare Fraud: Compliance and Ethics Committees must be cognizant of, Healthcare Compliance Perspective: Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 21 CFR 1317.15(d). Within the CSA, a controlled substance can be “disposed of” by destruction, return, recall, sale, or through the manufacturing process. The final rule in §§ 1317.05(b)(4) and 1317.95(c)(1) is modified to specify this requirement, which is designed to reduce the opportunities for diversion. 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