DQSA - Details on the new US Regulations for Lot and Item Level Tracing

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The DQSA (Drug Quality and Security Act) has recently passed the US Senate and was signed by President Obama on November 27. This blog looks into the details of this bill and the mandates as far as tracking and tracing of finished goods is concerned. The first part of the bill (sections 101 - 107) which is covering drug compounding will not be discussed in this blog. The Blog was updated Jan. 14, 2014 with some details (see below).

Please note: I got a decent headache reading the original bill! I tried to summarize the key topics and quote them in an abbreviated way, however, the content of this blog reflects my view on things, so read the original DQSA bill yourself, get your own headache and let me know your thoughts!

The bill basically contains 3 main provisions for pharmaceutical manufacturers:

1. Capturing transactions on a lot level (2015)
2. Serializing items on a package level and capturing these data in an electronic format (2017)
3. Serializing items on a package level and capturing these data in an electronic format incl. aggregation data in an electronic format which is fully electronically interoperable (2023)

The same or similar provisions are valid for wholesalers, re-packagers and dispensers however with slightly different timelines. I am focusing on the manufacturer’s requirements for now:

Lot-Level Transaction Data

Transaction Information, Transaction Statement and Transaction History have to be communicated on a batch level starting Jan 2015. This is a fixed date independent on when the bill gets signed. The bill states in "SEC. 582. REQUIREMENTS" ,(b)(1)(A) that "not later than January 1, 2015, a manufacturer shall ....provide the subsequent owner with transaction history, transaction information, and a transaction statement, in a single document in an paper or electronic format; and capture  ... and maintain such information, history, and statement for not less than 6 years after the date of the transaction."

The important terms here are Transaction Information (TI), Transaction Statement (TS) and Transaction History (TH) which are defined in the bill in "SEC. 581. DEFINITIONS":

"(25) TRANSACTION HISTORY .... means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

(26) TRANSACTION INFORMATION .... means

(A) the proprietary or established name or names of the product;

(B) the strength and dosage form of the product;

(C) the National Drug Code number of the product;

(D) the container size;

(E) the number of containers;

(F) the lot number of the product;

(G) the date of the transaction;

(H) the date of the shipment, if more than 24 hours after the date of the transaction;

(I) the business name and address of the person from whom ownership is being transferred; and

(J) the business name and address of the person to whom ownership is being transferred.

(27) TRANSACTION STATEMENT .... is a statement, in paper or electronic form, that the entity transferring ownership in a transaction

(A) is authorized ....;

(B) received the product from a person that is authorized ....;

(C) received transaction information and a transaction statement from the prior owner of the product....;

(D) did not knowingly ship a suspect or illegitimate product;

(E) had systems and processes in place to comply with verification requirements .... ;

(F) did not knowingly provide false transaction information; and

(G) did not knowingly alter the transaction history."

So the Transaction Information basically contains the classic information a recipient would need to know anyhow, e.g. what is shipped in terms of product (drug code, product name, strength, dosage form) and batch information as well as how much was shipped (size and number of units). In addition the transaction information requires the dates of transaction and shipment and the name and address of sender and receiver. All these data are available at the time of the shipment and just have to be compiled and attached to e.g. the ASN (Advanced Shipping Notification).

How are TI, TH and TS being transferred?

Two options are currently discussed in the industry. One option would be to use the Advanced Shipping Notification. This already holds some of the data and it could be enhanced to hold the missing data as well.

The other option makes use of an EPCIS message but would include lot level information rather then serialnumber level information. The latter has the advantage that the same methodology of transferring the information can be used when serialization will become a requirement.

The Transaction History basically would require to forward transaction information received from a supplier in case the product is just forwarded, so this is rather a wholesaler requirement than a manufacturer's requirement. However it's currently not clear (at least to me) how this affects product produced by a CMO.

Is the transaction history relevant for manufacturers?

Probably not! A manufacturer manufactures the product (sic!), therefopre there is no history. Same is true for re-packaging as this would create a new GTIN, so there is no history available for a this batch of this GTIN. Right now it is assumed that CMOs don't "own" the product, therefore no change of ownership takes place when a CMO ships finished product to the brand owner and therefore no need to send any information.

The Transaction Statement finally is what is says: a statement! Whether this has to include detailed information, e.g. the license number of the sender or any evidence for the statements made is (again at least to me) unclear at this point in time. Right now it is assumed that a standard statement is sufficient that can be placed on the shipment document or the invoice.

The bill states that one year after enactment (Nov. 27, 2014) the FDA shall provide guidance on the draft standards reg. TI/TH/TS. This however is very close to the date when these requirements have to be fulfilled (Jan 2015 !) And by Nov 2017 (4 years after enactment of the bill) all these data have to be transmitted electronically. Until then these data can also be transmitted on paper.

When does the change of Ownership happen?

Change of Ownership happens the moment a shipment reaches it's destination and the goods receipt (GR) is posted at the receiving site. This is typically governed in the contracts between the trading partners.

Serialization

By the end of 2017 (4 years after enactment of the bill) full serialization on a package level is required. The bill states in "SEC. 582. REQUIREMENTS" , (b)(2)(A): "Beginning not later than 4 years after the date of enactment ...., a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product .... . Such manufacturer shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction."

The important term here is "product identifier" which is defined in "SEC. 581. DEFINITIONS": “(14) PRODUCT IDENTIFIER .... means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier ....the standardized numerical identifier, lot number, and expiration date of the product.” and “(20) STANDARDIZED NUMERICAL IDENTIFIER .... means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code .... combined with a unique alphanumeric serial number of up to 20 characters.”

In addition, verification capabilities are required for both verification requests and returns, however only for single packages or sealed cases, so no aggregation is required. The bill states in "SEC. 582. REQUIREMENTS" ,(b)(4)(C): “Beginning 4 years after the date of enactment .... upon receiving a request for verification from an authorized repackager, wholesale distributor, or dispenser that is in possession or control of a product ...., a manufacturer shall....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." and in section (b)(4)(E): “Beginning 4 years after the date of enactment ...., 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.”

Full Track and Trace: Serialization and Aggregation

By the end of 2023, so 10 years after enactment, full serialization incl. aggregation is required. These requirements are set forth in "SEC. 203. ENHANCED DRUG DISTRIBUTION SECURITY". Chapter (g)(1) states that "... 10 years after the date of enactment" an "interoperable, electronic tracing of product at the package level requirements shall go into effect.

(A) The transaction information and the transaction statements …. shall be exchanged in a secure, interoperable, electronic manner.

(B) The transaction information …. shall include the product identifier at the package level for each package included in the transaction.

(C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required …. , which may include the use of aggregation and inference as necessary."

I hope this sheds some light on the new requirements. Please let me know your thoughts!