Q: What are a manufacturers 'Product Identifier' requirements as defined by DSCSA?

Starting 4 years after the enactment of the DSCSA: Affixing Product Identifiers: Requirement: Manufacturers must attach or imprint a unique product identifier on each package and homogeneous case of a product before it is introduced into the supply chain. Record Keeping: Manufacturers must keep the product identifier information for at least 6 years after the date of the transaction. Exception: Standardized Numerical Identifier: If a package already has a standardized numerical identifier, it does not need to have an additional unique device identifier.

Question 1

What are a manufacturers 'Product Tracing' requirements as defined by DSCSA?

Accepted Answer

(A) In general.--Beginning not later than January 1, 2015, a manufacturer shall--

``(i) prior to, or at the time of, each transaction in which such manufacturer transfers ownership of a product, provide the subsequent owner with transaction history, transaction information, and a transaction statement, in a single document in an paper or electronic format; and

``(ii) capture the transaction information (including lot level information), transaction history, and transaction statement for each transaction and maintain such information, history, and statement for not less than 6 years after the date of the transaction.

``(B) 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 manufacturer 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, based on the circumstances of the request, provide the applicable transaction information, transaction history, and transaction statement for the product.

``(C) Electronic format.--

``(i) In general.--Beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, except as provided under clause (ii), a manufacturer shall provide the transaction information, transaction history, and transaction statement required under subparagraph (A)(i) in electronic format.

``(ii) Exception.--A manufacturer may continue to provide the transaction information, transaction history, and transaction statement required under subparagraph

(A)(i) in a paper format to a licensed health care practitioner authorized to prescribe medication under State law or other licensed individual under the supervision or direction of such a practitioner who dispenses product in the usual course of professional practice.

Question 2

What are a manufacturers 'Product Identifier' requirements as defined by DSCSA?

Accepted Answer

(A) In general.--Beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Such manufacturer shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction.

``(B) Exception.--A package that is required to have a standardized numerical identifier is not required to have a unique device identifier.

Question 3

What are a manufacturers 'Authorized Trading Partners' requirements as defined by DSCSA?

Accepted Answer

Beginning not later than January 1, 2015, the trading partners of a manufacturer may be only authorized trading partners.

Question 4

What are a manufacturers 'Verification' requirements as defined by DSCSA?

Accepted Answer

Beginning not later than January 1, 2015, a manufacturer shall have systems in place to enable the manufacturer 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 manufacturer 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 manufacturer is a suspect product, a manufacturer shall--

``(I) quarantine such product within the possession or control of the manufacturer 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 manufacturer and otherwise investigating to determine whether the product is an illegitimate product, and, beginning 4 years after the date of enactment of the Drug Supply Chain Security Act, verifying the product at the package level, including the standardized numerical identifier.

``(ii) Cleared product.--If the manufacturer makes the determination that a suspect product is not an illegitimate product, the manufacturer shall promptly notify the Secretary, if applicable, of such determination and such product may be further distributed.

``(iii) Records.--A manufacturer 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 that a product in the possession or control of a manufacturer is an illegitimate product, the manufacturer shall, in a manner consistent with the systems and processes of such manufacturer--

``(I) quarantine such product within the possession or control of the manufacturer from product intended for distribution until such product is dispositioned;

``(II) disposition the illegitimate product within the possession or control of the manufacturer;

``(III) take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the manufacturer; 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 Secretary (or other appropriate Federal or State official), as necessary and appropriate.

``(ii) Making a notification.--

``(I) Illegitimate product.--Upon determining that a product in the possession or control of the manufacturer is an illegitimate product, the manufacturer shall notify the Secretary and all immediate trading partners that the manufacturer has reason to believe may have received such illegitimate product of such determination not later than 24 hours after making such determination.

``(II) High risk of illegitimacy.--A manufacturer shall notify the Secretary and immediate trading partners that the manufacturer has reason to believe may have in the trading partner's possession a product manufactured by, or purported to be a product manufactured by, the manufacturer not later than 24 hours after determining or being notified by the Secretary or a trading partner that there is a high risk that such product is an illegitimate product. For purposes of this subclause, a `high risk' may include a specific high risk that could increase the likelihood that illegitimate product will enter the pharmaceutical distribution supply chain and other high risks as determined by the Secretary in guidance pursuant to subsection (h).

``(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 manufacturer shall identify all illegitimate product subject to such notification that is in the possession or control of the manufacturer, 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 manufacturer shall promptly notify immediate trading partners that the manufacturer notified pursuant to clause (ii) that such notification has been terminated.

``(v) Records.--A manufacturer 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 4 years after the date of enactment of the Drug Supply Chain Security Act, upon receiving a request for verification from an authorized repackager, wholesale distributor, or dispenser that is in possession or control of a product such person believes to be manufactured by such manufacturer, a manufacturer shall, not later than 24 hours after receiving the request for verification 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 manufacturer. If a manufacturer responding to a request for verification identifies a product identifier that does not correspond to that affixed or imprinted by the manufacturer, the manufacturer shall treat such product as suspect product and conduct an investigation as described in subparagraph (A). If the manufacturer has reason to believe the product is an illegitimate product, the manufacturer shall advise the person making the request of such belief at the time such manufacturer responds to the request for verification.

``(D) Electronic database.--A manufacturer 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. 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 manufacturer of the requirement under this paragraph to respond to a request for verification submitted by means other than a secure electronic database.

``(E) Saleable returned product.--Beginning 4 years after the date of enactment of the Drug Supply Chain Security Act

(except as provided pursuant to subsection (a)(5)), upon receipt of a returned product that the manufacturer intends to further distribute, before further distributing such product, the manufacturer shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.

``(F) Nonsaleable returned product.--A manufacturer may return a nonsaleable product to the manufacturer or repackager, 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 described in paragraph (1)(A)(i).

Question 5

What are a manufacturers 'Product Tracing' requirements as defined by DSCSA?

Accepted Answer

Starting January 1, 2015

When transferring product ownership:

Before or at the time of transfer: Manufacturers must provide the new owner with:

Transaction History: A record of all prior transactions for the product.
Transaction Information: Details about the product, such as lot number and other relevant information.
Transaction Statement: A statement confirming the legitimacy of the transaction.

These three pieces of information must be provided together in a single document, which can be either paper or electronic.

Record Keeping:

Manufacturers must keep the transaction information, history, and statement for at least 6 years after the date of each transaction.

Information Requests:

If requested by the Secretary of Health and Human Services or other appropriate federal or state officials (for reasons such as a recall or investigating a suspicious or illegitimate product), the manufacturer must:

Provide the requested transaction information, history, and statement within 1 business day (or up to 48 hours) of the request, or within a reasonable time frame as determined by the Secretary based on the situation.

Electronic Format Requirement:

Starting 4 years after the enactment of the DSCSA:

Manufacturers must provide the required transaction information, history, and statement in an electronic format.

Exception: Manufacturers can still provide this information in paper format to licensed healthcare practitioners or individuals under their supervision who are authorized to dispense medication in their professional practice.

Question 6

What are a manufacturers 'Product Identifier' requirements as defined by DSCSA?

Accepted Answer

Starting 4 years after the enactment of the DSCSA:

Affixing Product Identifiers:

Requirement: Manufacturers must attach or imprint a unique product identifier on each package and homogeneous case of a product before it is introduced into the supply chain.

Record Keeping: Manufacturers must keep the product identifier information for at least 6 years after the date of the transaction.

Exception:

Standardized Numerical Identifier: If a package already has a standardized numerical identifier, it does not need to have an additional unique device identifier.

Question 7

What are a manufacturers 'Authorized Trading Partners' requirements as defined by DSCSA?

Accepted Answer

Beginning not later than January 1, 2015, the trading partners of a manufacturer may be only authorized trading partners.

Question 8

What are a manufacturers 'Verification' requirements as defined by DSCSA?

Accepted Answer

Starting January 1, 2015:

Suspect Product:

Determining a Suspect Product: If a manufacturer suspects a product is not legitimate, or the Secretary requests verification, the manufacturer must:

Quarantine the Product: Separate the suspect product from those intended for distribution until the issue is resolved.
Investigate Promptly: Work with trading partners to determine if the product is illegitimate. This includes validating transaction history and information and verifying the product at the package level (including the standardized numerical identifier) starting 4 years after DSCSA enactment.

Cleared Product: If the product is found to be legitimate, the manufacturer must notify the Secretary if applicable, and the product can be distributed.

Record Keeping: Keep records of the investigation for at least 6 years after it concludes.

Illegitimate Product:

Determining Illegitimacy: If a product is found to be illegitimate, the manufacturer must:

Quarantine the Product: Separate the illegitimate product from those intended for distribution until properly disposed of.
Dispose of the Product: Ensure the illegitimate product is removed from the supply chain.
Assist Trading Partners: Help trading partners to dispose of illegitimate products not in the manufacturer's possession.
Retain a Sample: Keep a sample for further examination or laboratory analysis if requested by the Secretary or appropriate officials.
Notification: Notify the Secretary and immediate trading partners within 24 hours if a product is found to be illegitimate or has a high risk of being so.

Responding to Notifications: Upon receiving notification that a product is illegitimate, the manufacturer must identify and handle all affected products in their possession.

Terminating Notifications: When a notification is no longer necessary, notify the trading partners who were informed.

Record Keeping: Keep records of the disposition of illegitimate products for at least 6 years after disposition.

Requests for Verification (Starting 4 years after DSCSA enactment):

Responding to Requests: Upon receiving a verification request from authorized parties, notify them within 24 hours whether the product identifier matches the one affixed by the manufacturer.

Handling Suspect Products: If the identifier does not match, treat the product as suspect and investigate accordingly. If it's believed to be illegitimate, inform the requester immediately.

Electronic Database:

Option to Use a Database: Manufacturers can use a secure electronic database to satisfy these requirements. This database can be developed by the manufacturer or another entity, and must meet all requirements for responding to verification requests.

Saleable Returned Product (Starting 4 years after DSCSA enactment):

Verifying Returned Products: Before redistributing a returned product, verify the product identifier, including the standardized numerical identifier, on each package or sealed homogeneous case.

Nonsaleable Returned Product:

Returning Nonsaleable Products: Manufacturers can return nonsaleable products to the manufacturer, repackager, or original wholesale distributor without providing the detailed information typically required for transactions.

DSCSA Manufacturer Requirements

The Law:

Layman's Terms*:

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Trust.med and Kvinta Unite to Offer Lifeline for Pharmaceutical Suppliers Struggling with United States Compliance Challenges

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