DSCSA Dispenser Requirements

Dispensers on the United States Drug Supply Chain must comply with the Drug Supply Chain Security Act (DSCSA). This quick dispenser DSCSA requirements reference provides all dispenser requirements from 'Section 582 Requirements' in an unedited form and are accurate as of 03/28/2022 4:22pm EST. All requirements, terms, and definitions are sourced directly from: Title II of the Drug Quality and Security Act.

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What are a dispensers 'Product Tracing' requirements as defined by DSCSA?
``(A) In general.--Beginning July 1, 2015, a dispenser--
                ``(i) shall not accept ownership of a product, unless the previous owner prior to, or at the time of, the transaction, provides transaction history, transaction information, and a transaction statement;
                ``(ii) prior to, or at the time of, each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns) shall provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product, except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need; and
                ``(iii) shall capture transaction information
            (including lot level information, if provided), transaction history, and transaction statements, as necessary to investigate a suspect product, and maintain such information, history, and statements for not less than 6 years after the transaction.
            ``(B) Agreements with third parties.--A dispenser may enter into a written agreement with a third party, including an authorized wholesale distributor, under which the third party confidentially maintains the transaction information, transaction history, and transaction statements required to be maintained under this subsection on behalf of the dispenser. If a dispenser enters into such an agreement, the dispenser shall maintain a copy of the written agreement and shall not be relieved of the obligations of the dispenser under this subsection.
            ``(C) Returns.--
                ``(i) Saleable returns.--A dispenser may return product to the trading partner from which the dispenser obtained the product without providing the information required under subparagraph (A).
                ``(ii) Nonsaleable returns.--A dispenser may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, to a returns processor, or to a person acting on behalf of such a person without providing the information required under subparagraph (A).
            ``(D) Requests for information.--Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect or an illegitimate product, a dispenser shall, not later than 2 business days after receiving the request or in another such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction statement, and transaction history which the dispenser received from the previous owner, which shall not include the lot number of the product, the initial transaction date, or the initial shipment date from the manufacturer unless such information was included in the transaction information, transaction statement, and transaction history provided by the manufacturer or wholesale distributor to the dispenser. The dispenser may respond to the request by providing the applicable information in either paper or electronic format. Until the date that is 4 years after the date of enactment of the Drug Supply Chain Security Act, the Secretary or other appropriate Federal or State official shall grant a dispenser additional time, as necessary, only with respect to a request to provide lot level information described in subparagraph (F) of section 581(26) that was provided to the dispenser in paper format, limit the request time period to the 6 months preceding the request or other relevant date, and, in the event of a recall, the Secretary, or other appropriate Federal or State official may request information only if such recall involves a serious adverse health consequence or death to humans.
What are a dispensers 'Product Identifier' requirements as defined by DSCSA?
Beginning not later than 7 years after the date of enactment of the Drug Supply Chain Security Act, a dispenser may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)).
What are a dispensers 'Authorized Trading Partners' requirements as defined by DSCSA?
Beginning not later than January 1, 2015, the trading partners of a dispenser may be only authorized trading partners.
What are a dispensers 'Verification' requirements as defined by DSCSA?
Beginning not later than January 1, 2015, a dispenser shall have systems in place to enable the dispenser to comply with the following requirements:
            ``(A) Suspect product.--
                ``(i) In general.--Upon making a determination that a product in the possession or control of the dispenser is a suspect product, or upon receiving a request for verification from the Secretary that has made a determination that a product within the possession or control of a dispenser is a suspect product, a dispenser shall--
 
                    ``(I) quarantine such product within the possession or control of the dispenser from product intended for distribution until such product is cleared or dispositioned; and
                    ``(II) promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product.
 
                ``(ii) Investigation.--An investigation conducted under clause (i)(II) shall include--
 
                    ``(I) beginning 7 years after the date of enactment of the Drug Supply Chain Security Act, verifying whether the lot number of a suspect product corresponds with the lot number for such product;
                    ``(II) beginning 7 years after the date of enactment of such Act, verifying that the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages, if there are fewer than 3, corresponds with the product identifier for such product;
                    ``(III) validating any applicable transaction history and transaction information in the possession of the dispenser; and
                    ``(IV) otherwise investigating to determine whether the product is an illegitimate product.
 
                ``(iii) Cleared product.--If the dispenser makes the determination that a suspect product is not an illegitimate product, the dispenser shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed or dispensed.
                ``(iv) Records.--A dispenser shall keep records of the investigation of a suspect product for not less than 6 years after the conclusion of the investigation.
            ``(B) Illegitimate product.--
                ``(i) In general.--Upon determining, in coordination with the manufacturer, that a product in the possession or control of a dispenser is an illegitimate product, the dispenser shall--
 
                    ``(I) disposition the illegitimate product within the possession or control of the dispenser;
                    ``(II) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the dispenser; and
                    ``(III) retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or Secretary (or other appropriate Federal or State official) upon request by the manufacturer or Secretary (or other appropriate Federal or State official), as necessary and appropriate.
 
                ``(ii) Making a notification.--Upon determining that a product in the possession or control of the dispenser is an illegitimate product, the dispenser shall notify the Secretary and all immediate trading partners that the dispenser has reason to believe may have received such illegitimate product of such determination not later than 24 hours after making such determination.
                ``(iii) Responding to a notification.--Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a dispenser shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser, including any product that is subsequently received, and shall perform the activities described in subparagraph (A).
                ``(iv) Terminating a notification.--Upon making a determination, in consultation with the Secretary, that a notification is no longer necessary, a dispenser shall promptly notify immediate trading partners that the dispenser notified pursuant to clause (ii) that such notification has been terminated.
                ``(v) Records.--A dispenser shall keep records of the disposition of an illegitimate product for not less than 6 years after the conclusion of the disposition.
            ``(C) Electronic database.--A dispenser may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity.
What are a dispensers 'Exceptions' under 'Sec. 582. Requirements' of DSCSA?
Notwithstanding any other provision of law, the requirements under paragraphs (1) and (4) shall not apply to licensed health care practitioners authorized to prescribe or administer medication under State law or other licensed individuals under the supervision or direction of such practitioners who dispense or administer product in the usual course of professional practice.

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