Last month I published an essay that analyzed the exemption language related to combination products contained in the old California pedigree law and in H.R. 3204, which was later signed into law as the Drug Quality and Security Act (DQSA) (see “Drug-Device Combo Products Under State And Federal Pedigree Laws”). In that essay I showed how these exemptions were very similar because both were based on the existing definition of a “combination product” from 21 CFR 3.2(e). My assessment of the effect of the wording in the old California pedigree law is still valid, in my opinion, but I now believe my analysis of the language in H.R. 3204 was incorrect. Here is why. Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA
Tag Archives: PMOA
Drug-Device Combo Products Under State And Federal Pedigree Laws
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.
The drug-device combo product exemption language included in the California Business and Professions Code, 4034(g)(9), is almost identical to the language in H.R. 3204, 581(24)(B)(xii). There is a reason for that. They are both based on part of the FDA’s definition for a drug-device combination product, found in 21 CFR 3.2 (e). Continue reading Drug-Device Combo Products Under State And Federal Pedigree Laws
