21 CFR 1317.40. 822. (1) Collectors that acquire controlled substances from ultimate users are exempt from the ARCOS reporting requirements only with respect to controlled substances collected through mail-back programs and collection receptacles for the purpose of disposal. Background. The compliance officer shall commence an investigation as soon, Compliance Perspective: Records for treatment programs that compound narcotics for treatment programs and other locations. In the final rule the definition is modified, but it still only pertains to those persons who may be permitted to directly participate in the disposal process. The USPS also requested that the DEA state that collectors operating a mail-back program must exclusively use the United States Postal Service. Response: The recordkeeping requirements in § 1304.22(e)(4) that apply to controlled substances acquired by registrants that reverse distribute from collectors also apply to those acquired from law enforcement. In § 1301.72, revise paragraph (a) introductory text to read as follows: (a) Schedules I and II. These commenters stated that three days is too short a time span and will result in residents being forced to purchase additional medications when there is a short break in use as a result of illness, hospitalization, or a trial dosage reduction. on (3) A long-term care facility on behalf of an ultimate user who resides or resided at such long-term care facility and is/was in lawful possession of a controlled substance, in accordance with § 1317.80 only. In addition to retail pharmacies (including “closed-door pharmacies” that service LTCFs), hospitals/clinics with an on-site pharmacy may maintain collection receptacles at LTCFs. (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. The DEA appreciates there is a cost to entities that choose voluntarily to provide these methods of collection and destruction. of each inner liner removed, the registration number of the collector, and the names and signatures of the two employees that witnessed each removal; (iv) Date each sealed inner liner is transferred to storage, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) 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: Not all registrants are eligible to become authorized collectors. (4) Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located. Nonetheless, the DEA recognizes that some ultimate users may not have convenient access to any of the disposal options available in this rule. Collectors that are non-practitioners (i.e., manufacturers, distributors, narcotic treatment programs, and reverse distributors) shall dispose of sealed inner liners and their contents by utilizing any method in paragraph (b)(1), (b)(2), or (b)(4) of this section, or by delivering sealed inner liners and their contents to a distributor's registered location by common or contract carrier or by distributor pick-up at the collector's authorized collection location for destruction. Conversely, LTCFs and destruction facilities are generally not registrants. [9] Issue: One commenter asked the DEA to clarify that no Federal or State government entity may require registrants to amend their DEA registration to become authorized collectors. Enhanced security procedures proposed for § 1317.15 ( c ) ( 4 ) request assistance from collection! Have choices with respect to the disposal of pharmaceutical controlled substances from receptacles... 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