Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA. In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s). Let’s take a closer look. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?→
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?
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.
Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products. This is an expanding category of products so this exemption is worthy of a closer look.
Not all prescription drugs will need to comply with the California pedigree law on January 1, 2015 or 2016. In fact, there are a number of important exemptions that cover entire classes of certain drugs and certain types of transactions for all drugs. The volume of drug packages that could escape being serialized and pedigreed by those effective dates is not huge, but if you are a manufacturer or wholesaler, you should familiarize yourself with the list of exemptions. If you are lucky enough to make or handle any of the exempt drugs or transactions you might as well take advantage of your exemption.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.