DSCSA Repackager Requirements

Repackagers on the United States Drug Supply Chain must comply with the Drug Supply Chain Security Act (DSCSA). This quick repackager DSCSA requirements reference provides all repackager requirements from 'Section 582 Requirements' in an unedited form and are accurate as of 03/28/2022 4:43pm 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 repackagers 'Product Tracing' requirements as defined by DSCSA?
``(A) In general.--Beginning not later than January 1, 2015, a repackager described in section 581(16)(A) shall--
                ``(i) 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 for the product;
                ``(ii) prior to, or at the time of, each transaction in which the repackager transfers ownership of a product, provide the subsequent owner with transaction history, transaction information, and a transaction statement for the product; and
                ``(iii) capture the transaction information (including lot level information), transaction history, and transaction statement for each transaction described in clauses (i) and (ii) and maintain such information, history, and statement for not less than 6 years after the transaction.
            ``(B) Returns.--
                ``(i) Nonsaleable product.--A repackager described in section 581(16)(A) may return a nonsaleable product to the manufacturer or repackager, or to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such a person, including a returns processor, without providing the information required under subparagraph (A)(ii).
                ``(ii) Saleable or nonsaleable product.--A repackager described in section 581(16)(B) may return a saleable or nonsaleable product to the manufacturer, repackager, or to the wholesale distributor from whom such product was received without providing the information required under subparagraph (A)(ii) on behalf of the hospital or other health care entity that took ownership of such product pursuant to the terms and conditions of any agreement between such repackager and the entity that owns the product.
            ``(C) 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 product or an illegitimate product, a repackager described in section 581(16)(A) shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request or in other such reasonable time as determined by the Secretary, provide the applicable transaction information, transaction history, and transaction statement for the product.
What are a repackagers 'Product Identifier' requirements as defined by DSCSA?
``(A) In general.--Beginning not later than 5 years after the date of enactment of the Drug Supply Chain Security Act, a repackager described in section 581(16)(A)--
                ``(i) shall affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction in commerce;
                ``(ii) shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction;
                ``(iii) 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)); and
                ``(iv) shall maintain records for not less than 6 years to allow the repackager to associate the product identifier the repackager affixes or imprints with the product identifier assigned by the original manufacturer of the product.
            ``(B) Exception.--A package that is required to have a standardized numerical identifier is not required to have a unique device identifier.
What are a repackagers 'Authorized Trading Partners' requirements as defined by DSCSA?
Beginning January 1, 2015, the trading partners of a repackager described in section 581(16) may be only authorized trading partners.
What are a repackagers 'Verification' requirements as defined by DSCSA?
Beginning not later than January 1, 2015, a repackager described in section 581(16)(A) shall have systems in place to enable the repackager 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 repackager 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 repackager is a suspect product, a repackager shall--
 
                    ``(I) quarantine such product within the possession or control of the repackager 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, which shall include validating any applicable transaction history and transaction information in the possession of the repackager and otherwise investigating to determine whether the product is an illegitimate product, and, beginning 5 years after the date of enactment of the Drug Supply Chain Security Act
                (except as provided pursuant to subsection (a)(5)), verifying the product at the package level, including the standardized numerical identifier.
 
                ``(ii) Cleared product.--If the repackager makes the determination that a suspect product is not an illegitimate product, the repackager shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed.
                ``(iii) Records.--A repackager 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 repackager is an illegitimate product, the repackager shall, in a manner that is consistent with the systems and processes of such repackager--
 
                    ``(I) quarantine such product within the possession or control of the repackager from product intended for distribution until such product is dispositioned;
                    ``(II) disposition the illegitimate product within the possession or control of the repackager;
                    ``(III) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the repackager; and
                    ``(IV) 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 repackager is an illegitimate product, the repackager shall notify the Secretary and all immediate trading partners that the repackager has reason to believe may have received the 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, a repackager shall identify all illegitimate product subject to such notification that is in the possession or control of the repackager, 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 repackager shall promptly notify immediate trading partners that the repackager notified pursuant to clause (ii) that such notification has been terminated.
                ``(v) Records.--A repackager shall keep records of the disposition of an illegitimate product for not less than 6 years after the conclusion of the disposition.
            ``(C) Requests for verification.--Beginning 5 years after the date of enactment of the Drug Supply Chain Security Act, upon receiving a request for verification from an authorized manufacturer, wholesale distributor, or dispenser that is in possession or control of a product they believe to be repackaged by such repackager, a repackager shall, not later than 24 hours after receiving the verification request or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, notify the person making the request whether the product identifier, including the standardized numerical identifier, that is the subject of the request corresponds to the product identifier affixed or imprinted by the repackager. If a repackager responding to a verification request identifies a product identifier that does not correspond to that affixed or imprinted by the repackager, the repackager shall treat such product as suspect product and conduct an investigation as described in subparagraph (A). If the repackager has reason to believe the product is an illegitimate product, the repackager shall advise the person making the request of such belief at the time such repackager responds to the verification request.
            ``(D) Electronic database.--A repackager may satisfy the requirements of paragraph (4) by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain, as appropriate. The development and operation of such a database shall not relieve a repackager of the requirement under subparagraph (C) to respond to a verification request submitted by means other than a secure electronic database.
            ``(E) Verification of saleable returned product.--Beginning 5 years after the date of enactment of the Drug Supply Chain Security Act, upon receipt of a returned product that the repackager intends to further distribute, before further distributing such product, the repackager shall verify the product identifier for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier on each package.
What are a repackagers 'Drop Ship' requirements as defined by DSCSA?
``(1) In general.--A wholesale distributor that does not physically handle or store product shall be exempt from the provisions of this section, except the notification requirements under clauses (ii), (iii), and (iv) of subsection (c)(4)(B), provided that the manufacturer, repackager, or other wholesale distributor that distributes the product to the dispenser by means of a drop shipment for such wholesale distributor includes on the transaction information and transaction history to the dispenser the contact information of such wholesale distributor and provides the transaction information, transaction history, and transaction statement directly to the dispenser.
        ``(2) Clarification.--For purposes of this subsection, providing administrative services, including processing of orders and payments, shall not by itself, be construed as being involved in the handling, distribution, or storage of a product.''.

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