Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA

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

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2 thoughts on “Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA”

  1. Dirk,

    Thanks for another excellent assessment. I had always viewed these sections of CA BoP & HR3204, which resulted in analyzing options for exemption, to be a distraction. One should only need to consider what the “spirit of the law” is to conclude that loopholes to exempt some drug products were not intended. It may be an oversimplification on my part, but generally speaking, if the product was filed and approved by FDA using the NDA or ANDA process, it is in scope.
    Best regards,
    David Colombo

    1. David,
      I think your suggested approach is a good one for most companies, especially now that we are dealing with a Federal regulation, but some companies may need to take advantage of as many exemptions as they can, at least initially, to help them focus on those that are definitely not exempt.


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