(a) Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(B) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section.
(b) Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescription use under section 503(b)(1)(B) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling. A proposal to exempt a drug from the prescription-dispensing requirements of section 503(b)(1)(B) of the act may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, which petition may be pursuant to part 10 of this chapter, or in the form of a supplement to an approved new drug application.
(c) New drug status of drugs exempted from the prescription requirement. A drug exempted from the prescription requirement under the provisions of paragraph (b) of this section is a “new drug” within the meaning of section 201(p) of the act until it has been used to a material extent and for a material time under such conditions except as provided in paragraph (e) of this section.
(d) Prescription legend not allowed on exempted drugs. The use of the prescription caution statement quoted in section 503(b) (4) of the act, in the labeling of a drug exempted under the provisions of this section, constitutes misbranding. Any other statement or suggestion in the labeling of a drug exempted under this section, that such drug is limited to prescription use, may constitute misbranding.
(e) Prescription-exemption procedure of OTC drug review. A drug limited to prescription use under section 503(b)(1)(B) of the act may also be exempted from prescription-dispensing requirements by the procedure set forth in § 330.13 of this chapter.
[39 FR 11680, Mar. 29, 1974, as amended at 41 FR 32582, Aug. 4, 1976; 42 FR 4714, Jan. 25, 1977; 42 FR 15674, Mar. 22, 1977; 72 FR 15043, Mar. 30, 2007]
Notes of Decisions
Cited in
9
cases, 1977–2013 · leading case:
Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y 2009).
Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y 2009).
· cites it 2× “21 C.F.R. § 310.200 (b). Many new drugs are initially approved for prescription-only status and then later considered for nonprescription status, i.”
Tummino v. Von Eschenbach Ex Rel. Food & Drug Admin., 427 F. Supp. 2d 212 (E.D.N.Y 2006).
· cites it 2× “Under 21 C.F.R. § 310.200 (b), "[a] proposal to exempt a drug from the prescription-dispensing requirements of section 503(b)(1)(C) of the act may be initiated by the Commissioner or by any interested person.”
Robinson v. McNeil Consum. Healthcare, 615 F.3d 861 (7th Cir. 2010).
“The agency bases its decision on whether the drug is safe and effective for use without a doctor’s permission, 21 C.F.R. § 310.200 (b); and it has decided not to require that drugs containing ibuprofen be sold by prescription only.”
Tummino v. Hamburg, 936 F. Supp. 2d 162 (E.D.N.Y 2013).
· cites it 2× “Indeed, 21 C.F.R. § 310.200 (b) expressly provides that the Commissioner may initiate, sua sponte, a proposal to exempt a drug from *175 prescription-dispensing requirements “when the Commissioner finds such requirements are not necessary for the protection of the public health.”
Parke, Davis & Co. v. Joseph A. Califano, Sec'y of Health, Educ. & Welfare, 623 F.2d 1 (6th Cir. 1980).
“*4 Most of the documents which the district court ordered disclosed were generated in Parke Davis’s efforts to obtain OTC approval of Benylin under the “traditional” or “switch over” procedure prescribed in 21 C.F.R. § 310.200 . Section 310.200(b) provides, “[a]ny interested…”
Tummino v. Hamburg, 260 F.R.D. 27 (E.D.N.Y 2009).
· cites it 2× “§ 353 (b)(3); 21 C.F.R. § 310.200 (b); id. § 10.25(a)).”
Parke, Davis & Co. v. Califano, 564 F.2d 1200 (6th Cir. 1977).
· cites it 2× “On November 25,1974 Parke Davis submitted a supplemental NDA seeking approval for *1202 over-the-counter marketing of Benylin under the traditional procedure prescribed in 21 CFR § 310.200 , known as a “switch over.”
Karen Robinson v. McNeil Consum. Healthcare (7th Cir. 2010).
“The agency bases its decision on whether the drug is safe and effective for use without a doctor’s permission, 21 C.F.R. § 310.200 (b); and it has decided not to require that drugs containing ibuprofen be sold by prescription only.”
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