Block, Report, and Suspend Suspicious Shipments Act

To amend the Controlled Substances Act to require registrants to decline to fill certain suspicious orders, and for other purposes. 1. Short title This Act may be cited as the Block, Report, and Suspend Suspicious Shipments Act 2. Block, report, and suspend suspicious orders (a) Clarification of process for registrants To exercise due diligence upon discovering a suspicious order Section 312(a) of the Controlled Substances Act ( 21 U.S.C. 832(a) (1) in paragraph (2), by striking and (2) by striking paragraph (3) and inserting the following paragraphs: (3) determine whether an order or series of orders is suspicious, taking into consideration— (A) any unusual size, pattern, or frequency of the order or series of orders; and (B) any customer business model, dispensing patterns, prior orders, or other characteristics that may indicate the order or series of orders is suspicious, despite the particular order or series of orders not exhibiting an unusual size, pattern, or frequency; and (4) upon discovering suspicious circumstances regarding an order or series of orders, and in a manner consistent with the other requirements of this section— (A) decline to fill the order or series of orders, establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the order or series of orders, and notify the Administrator of the Drug Enforcement Administration for the purpose of including information on such order or series of orders in the centralized database established under subsection (b)(1); or (B) exercise due diligence as appropriate and— (i) (I) if the due diligence fails to dispel all of the indicators that give rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted, decline to fill the order or series of orders; or (II) if the due diligence does dispel all such indicators, fill the order or series of orders; (ii) establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the order or series of orders and the due diligence that was performed; and (iii) notify the Administrator of the Drug Enforcement Administration for the purpose of including information on such order or series of orders in the centralized database established under subsection (b)(1), including any indicators giving rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted. . (b) Regulations Not later than 1 year after the date of enactment of this Act, for purposes of section 312(a)(4) of the Controlled Substances Act, as inserted by subsection (a), the Attorney General of the United States shall promulgate a final regulation specifying— (1) the indicators that give rise to a suspicion that, if an order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted; (2) a definition of due diligence; and (3) in the case of a registrant that dispels all of the indicators giving rise to a suspicious order or series of orders, the circumstances in which the registrant is not required to file the notification under such section 312(a)(4). (c) Penalty Section 402(a)(5) of the Controlled Substances Act ( 21 U.S.C. 842(a)(5) , including any such violation of section 312(a)(4) (d) Applicability Section 312(a)(4) of the Controlled Substances Act, as inserted by subsection (a), shall apply beginning on the day that is 1 year after the date of enactment of this Act. Until such day, section 312(a)(3) of the Controlled Substances Act shall apply as such section 312(a)(3) was in effect on the day before the date of enactment of this Act. (e) Sense of Congress It is the sense of Congress that— (1) medications for opioid use disorder significantly reduce the risk of overdose death; and (2) the requirements of this Act are not intended to impair access to controlled substances primarily used to treat opioid use disorder. May 17, 2023 Reported from the Committee on Energy and Commerce May 17, 2023 Committee on the Judiciary

Summary: Block, Report, And Suspend Suspicious Shipments Act This bill creates additional requirements for drug manufacturers and distributors who discover a suspicious order or series of suspicious orders for controlled substances. Currently, a manufacturer or distributor must report a suspicious order or series of suspicious orders to the Drug Enforcement Administration (DEA). This bill also requires a manufacturer or distributor to exercise due diligence and decline to fill the order. However, if the manufacturer or distributor resolves all of the indicators giving rise to the suspicious order or series of suspicious orders, then the bill allows the manufacturer or distributor to fill the order and choose not to report it to the DEA. A violation is subject to civil and criminal penalties under the Controlled Substances Act. The DEA must issue regulations specifying the indicators that give rise to a suspicious order.