C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS › Subpart B—General Provisions

21 C.F.R. § 610.17

Permissible combinations

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Licensed products may not be combined with other licensed products either therapeutic, prophylactic or diagnostic, except as a license is obtained for the combined product. Licensed products may not be combined with nonlicensable therapeutic, prophylactic, or diagnostic substances except as a license is obtained for such combination.

Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2019–2021 · leading case: Skibo v. Greer Labs., Inc. (W.D.N.C. 2019).
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Skibo v. Greer Labs., Inc. (W.D.N.C. 2019). · cites it 3× “The relevant FDA regulation, 21 C.F.R. § 610.17 , was enacted in 1947.”
Liubov Skibo v. Greer Labs., Inc. (4th Cir. 2021). · cites it 2× “” 21 C.F.R. § 610.17 . In February 2015, 40 years after the regulation was enacted, the FDA released a draft guidance document titled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for Industry.”
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