The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:
(a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. Special cases of this general rule are where a component is added:
(1) To enhance the safety or effectiveness of the principal active component; and
(2) To minimize the potential for abuse of the principal active component.
(b) If a combination drug presently the subject of an approved new-drug application has not been recognized as effective by the Commissioner of Food and Drugs based on his evaluation of the appropriate National Academy of Sciences-National Research Council panel report, or if substantial evidence of effectiveness has not otherwise been presented for it, then formulation, labeling, or dosage changes may be proposed and any resulting formulation may meet the appropriate criteria listed in paragraph (a) of this section.
(c) A fixed-combination prescription drug for humans that has been determined to be effective for labeled indications by the Food and Drug Administration, based on evaluation of the NAS-NRC report on the combination, is considered to be in compliance with the requirements of this section.
[40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999]
Notes of Decisions
Gillis v. QRX Pharma Ltd., 197 F. Supp. 3d 557 (S.D.N.Y. 2016).
· cites it 3× “” 21 C.F.R. § 300.50 (a); SAC ¶ 15. The Combination Rule “does not specifically address the issue of combining two drugs from the same pharmacological class.”
United States v. 225 Cartons, More or Less, of an Article of Drug, 687 F. Supp. 946 (D.N.J. 1988).
· cites it 4× “Another particularly pertinent regulation is set forth in 21 C.F.R. § 300.50 and provides in part: (a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency,…”
United States v. X-Otag Plus Tablets, 441 F. Supp. 105 (D. Colo. 1977).
“21 C.F.R. § 300.50 . The second issue relates to a drug containing the same components, but in different amounts as a generally recognized combination drug.”
Smithkline Corp. v. Food & Drug Admin., 587 F.2d 1107 (D.C. Cir. 1978).
“21 C.F.R. § 300.50 (a) (1977). In addition, FDA has specified criteria for the “adequate and well-controlled investigations” acceptable as substantial evidence of effectiveness.”
United States v. Seven Cardboard Cases of an Article of Drug, 716 F. Supp. 1221 (E.D. Mo. 1989).
“For combination drug products, the sponsor must also show that each component makes a contribution to the claimed effects, and the dosage of each component is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy.”
Arnold P'ship v. Rogan, 246 F. Supp. 2d 460 (E.D. Va. 2003).
“Although plaintiffs argument makes some sense, the plain language of § 156 and the overall structure of the Act demonstrate that Congress was not concerned with the FDA’s practice of approving an application for a combination drug by evaluating just the combination of active…”
— 21 C.F.R. § 300.50(a) — 1 case
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