This past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained. The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”. This time the book is available as a paperback and at the much more affordable price of only US$59.99.
When the U.S. Drug Supply Chain Security Act (DSCSA) was signed into law last November, it introduced a new term into the supply chain lexicon: “Dispenser”. It is unfortunate that the authors chose not to use a more recognizable word—like “pharmacies”, or “hospitals”, or “physicians”—because, if they had, more organizations in the dispensing sector might have taken more notice of the requirements they are facing. But, of course, they could not do that because they wanted to refer to all of those organizations using a single term. All of those types of organizations fall into the DSCSA definition of “dispensers” and the use of that word appears to have led to some confusion, and therefore some amount of complacency.
“Dispenser” is one of the terms the DSCSA defines so that the rest of the text does not need to repeat the full list of organizations the authors are referring to (see “Don’t Skip The DQSA Definition of Terms Section”). Its definition is only applicable Continue reading Who Is A DSCSA Dispenser?
I am working this week, but I know this is a popular time for vacations, especially for those who do not have children in school. I typically write my Monday essays over the weekend, but because it was a holiday weekend and my wife and I did some leisure traveling, I decided to re-post a popular essay from earlier this year: “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?“.
I wrote this essay to help companies, large and small, figure out whether or not their products might be exempt from the DSCSA. In it, I provide a kind of a formula that you can use to determine if a given product is exempt or not. At least it’s a series of questions or statements that you can ask yourself about your product. So without further ado,
IS YOUR DRUG EXEMPT FROM THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT?
Ever since the Drug Quality and Security Act (DQSA) was signed into law last November Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited
Please respond to this very brief survey and enter to win a single user license to “The Drug Supply Chain Security Act Explained” by Dirk Rodgers. One lucky winner will be selected from the respondents who voluntarily leave their contact info by close of business on July 27, 2014. Tell me what you like and what could be improved on Rxtrace. Click on this link to begin: https://www.surveymonkey.com/s/2014RxTraceReadersSurvey.
Thanks for reading, and thanks for helping to make RxTrace a better resource. Continue reading 2014 RxTrace Reader Survey
Ever since the Drug Quality and Security Act (DQSA) was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), more and more people are asking the question, “Does my drug have to follow the DQSA?”. Recently I was on a monthly industry call put on by one of the Big 3 wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.
I was surprised how many people asked the wholesaler if their specific product was covered or exempt. Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.
In fact, no one can answer that question for you. Even the FDA can’t answer that question for you. I can’t answer that question for you. Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA. I can help you with that part. Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?
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