This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet. When allowed, grandfathering allows Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL? Again
Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet. When allowed, grandfathering allows a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply. For example, Section 582(a)(5)(B) of the Drug Supply Chain Security Act (DSCSA) allows wholesale distributors, and repackagers to sell drugs that were already within the supply chain on January 1, 2015 without passing the necessary transaction data. This makes sense because companies were not obligated to supply that data before that date and so some of the assertions required in the Transaction Statement would not be true (among other problems that grandfathering eliminates). [Of course, Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?
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
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?