(a) The drugs listed in this paragraph (a) have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of this chapter is required for marketing the following drugs:
(1) Aerosol drug products for human use containing 1,1,1-trichloroethane.
(2) Aerosol drug products containing zirconium.
(3) Amphetamines (amphetamine, dextroamphetamine, and their salts, and levamfetamine and its salts) for human use.
(4) Camphorated oil drug products.
(5) Certain halogenated salicylanilides (tribromsalan (TBS, 3,4′,5-tribromosalicylanilide), dibromsalan (DBS, 4′, 5-dibromosalicylanilide), metabromsalan (MBS, 3, 5-dibromosalicylanilide), and 3,3′, 4,5′-tetrachlorosalicylanilide (TC-SA)) as an ingredient in drug products.
(6) Chloroform used as an ingredient (active or inactive) in drug products.
(7) Cobalt preparations intended for use by man.
(8) Intrauterine devices for human use for the purpose of contraception that incorporate heavy metals, drugs, or other active substances.
(9) Oral prenatal drugs containing fluorides intended for human use.
(10) Parenteral drug products in plastic containers.
(11) [Reserved]
(12) Sweet spirits of nitre drug products.
(13) Thorium dioxide for drug use.
(14) Timed release dosage forms.
(15) Vinyl chloride as an ingredient, including propellant, in aerosol drug products.
(b) [Reserved]
[62 FR 12084, Mar. 14, 1997, as amended at 64 FR 401, Jan. 5, 1999; 84 FR 68334, Dec. 16, 2019]
Notes of Decisions
Spychala v. G.D. Searle & Co., 705 F. Supp. 1024 (D.N.J. 1988).
· cites it 11× “” ( 21 C.F.R. § 310.502 ). The FDA was concerned with the availability of information regarding the complications associated with and the side effects of drug IUD use.”
Humes v. Clinton, 792 P.2d 1032 (Kan. 1990).
· cites it 5× “21 C.F.R. § 310.502 (1989). Dr. Clinton testified he would have given Brenda Humes the patient brochure if he had known of this federal regulation.”
Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293 (D. Minn. 1988).
· cites it 4× “21 C.F.R. § 310.502 . The parties agree that the above-cited regulation includes the copper-based Cu-7.”
Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511 (S.D. Fla. 1990).
· cites it 3× “Although failure to comply with federal standards might very well provide a vehicle by which to argue that the manufacturer was negligent, this Court is not persuaded that the federal regulations contained in 21 C.F.R. Section 310.502 should redefine the scope of this cause of…”
Callan v. G.D. Searle & Co., 709 F. Supp. 662 (D. Md. 1989).
· cites it 4× “This subsection acknowledges that the efficacy of these IUDs is correlated to local irritation, but also notes that investigators had found that different pregnancy rates appeared to be dependent on the type of metal used and/or the amount of exposed surface of metal.”
Lacy v. G.D. Searle & Co., 567 A.2d 398 (Del. 1989).
· cites it 2× “See *399 21 C.F.R. § 310.502 (b)(2) (1987). The Superior Court held that Searle had satisfied its duty pursuant to the federal regulation by enclosing a patient information brochure with the IUD, and that Lacy was foreclosed from alleging that the brochure was insufficient…”
Tarallo v. Searle Pharm., Inc., 704 F. Supp. 653 (D.S.C. 1988).
· cites it 3× “2 It must provide a written document which includes among other topics a description of the product, its mode of action or principles of design, any warnings, precautions or adverse reactions associated with the IUD and directions for its use.”
Hill v. Searle Labs., 686 F. Supp. 720 (E.D. Ark. 1988).
· cites it 3× “Information about the CU-7 was submitted to the United States Food and Drug Administration (FDA) in the form of a new drug application (NDA), pursuant to 21 C.F.R. § 310.502 . In February, 1974 the FDA approved the new drug application, finding the CU-7 to be safe and effective,…”
A.H. Robins Co. v. Piccinin, 788 F.2d 994 (4th Cir. 1986).
“For the current FDA regulation on intrauterine devices, see 21 C.F.R. § 310.502 (1984). . Book Note, 99 Harv.”
Allen v. G.D. Searle & Co., 708 F. Supp. 1142 (D. Or. 1989).
“427; 21 C.F. R. 310.502. Allen and Keys respond that the FDA continued to recognize the distinction between IUDs as drugs and IUDs as devices after the Medical Device Amendments.”
Hill v. Searle Labs., 884 F.2d 1064 (8th Cir. 1989).
· cites it 2× “21 C.F.R. § 310.502 (b). Dr. Davidson, who treated Hill, was fully aware of the risk of perforation associated with the use of a CU-7 or any IUD.”
21 C.F.R. § 310.502(2): 1 case
Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511 (S.D. Fla. 1990).
“Although failure to comply with federal standards might very well provide a vehicle by which to argue that the manufacturer was negligent, this Court is not persuaded that the federal regulations contained in 21 C.F.R. Section 310.502 should redefine the scope of this cause of…”
21 C.F.R. § 310.502(b)(1): 1 case
Tarallo v. Searle Pharm., Inc., 704 F. Supp. 653 (D.S.C. 1988).
“2 It must provide a written document which includes among other topics a description of the product, its mode of action or principles of design, any warnings, precautions or adverse reactions associated with the IUD and directions for its use.”
21 C.F.R. § 310.502(b)(2): 1 case
Spychala v. G.D. Searle & Co., 705 F. Supp. 1024 (D.N.J. 1988).
“” ( 21 C.F.R. § 310.502 ). The FDA was concerned with the availability of information regarding the complications associated with and the side effects of drug IUD use.”
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