21 C.F.R. § 201.50
Statement of identity
(a) The label of prescription and insulin-containing drugs in package form shall bear as one of its principal features a statement of the identity of the drug.
(b) Such statement of identity shall be in terms of the established name of the drug. In the case of a prescription drug that is a mixture and that has no established name, the requirement for statement of identity shall be deemed to be satisfied by a listing of the quantitative ingredient information as prescribed by § 201.10.
(c) The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of § 201.10.
Notes of Decisions
Cited in 2
cases, 1988–1991 · leading case: Abbot v. Am. Cyanamid Co., 844 F.2d 1108 (4th Cir. 1988).
Abbot v. Am. Cyanamid Co., 844 F.2d 1108 (4th Cir. 1988). “The FDA requires that the label or package insert for a biological product contain among others: (1) the composition of the product; (2) the product’s administration schedule; (3) indication and contraindication of product usage; and (4) potential adverse reactions associated…”
Erva Pharm., Inc. v. Am. Cyanamid Co., 755 F. Supp. 36 (D.P.R. 1991). “It further concedes that the label does not comply with the prominence standards, as required by 21 C.F.R. § 201.50 . Id. at 9-10 . In 1962, Congress amended the FD & C Act to require the manufacturers of prescription drugs to print the established name of the drug prominently…”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.