The Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0. This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law. The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review. What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities. Continue reading InBrief: HDMA Updates DSCSA Q&A
This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect. The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices. This year Continue reading 2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!
For the second year in a row RxTrace is partnering with Frequentz to conduct a survey about U.S. Pharma Traceability. This year the survey has been improved with separate sets of questions for each segment of the supply chain and also for companies who are not actual supply chain members. The survey asks questions about the readiness of companies for the 2015 requirements of the DSCSA as well as preparations for the 2017 serialization requirements. A few of the questions are the same as last year so we can track any change in thinking.
This is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH). The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction Statement (TS) this way:
“(27) TRANSACTION STATEMENT.—
The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—
This is the second in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January. Last week’s essay was about DSCSA Transaction Information (TI). On the surface, Transaction History (TH) looks simple. The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines TH this way:
“(25) TRANSACTION HISTORY.—
The term ‘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.”
According to this simple definition, Continue reading DSCSA: Transaction History
In the new U.S. Drug Supply Chain Security Act (DSCSA) enacted last November as part of the Drug Quality and Security Act (DQSA), “Transaction Information” (TI) is one of three primary sets of data that supply chain sellers of drugs must provide to the buyers beginning January 1 of next year. I will discuss “Transaction History” (TH) and “Transaction Statements” (TS) in future essays.
On first look, TI can seem pretty simple. Here is how the DSCSA defines it:
“(26) TRANSACTION INFORMATION.—
The term ‘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 (NDC) 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.”
Sounds kind of like a delivery manifest or packing list. Continue reading DSCSA: Transaction Information
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
The U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format. Ironically, they will accept responses to the docket in either paper or electronic format. Comments should be submitted to the FDA within 60 days. If my calculation is correct, you have until April 21st to submit your comments.
This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)]. I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“). This docket fulfills the first of many mandates that the FDA is facing in