Source: https://www.law.cornell.edu/cfr/text/21/310.545
Timestamp: 2017-09-23 02:15:35
Document Index: 723383006

Matched Legal Cases: ['art 310', '§ 310', '§ 355', '§ 347', '§ 358', '§ 358', '§ 347', '§ 310', '§ 310', '§ 242']

21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 310 › Subpart E › Section 310.545
21 CFR 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
§ 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
Link to an amendment published at 81 FR 61129, Sept. 6, 2016.
(1)Topical acne drug products.
(2)Anticaries drug products -
(i)Approved as of May 7, 1991.
(ii)Approved as of October 7, 1996.
1 These ingredients are nonmonograph except when used to prepare acidulated phosphate fluoride treatment rinses identified in § 355.10(a)(3) of this chapter.
(3)Antidiarrheal drug products -
(ii)Approved as of April 19, 2004; April 18, 2005, for products with annual sales less than $25,000.
(4)Antiperspirant drug products -
(i)Ingredients - Approved as of May 7, 1991.
(ii)Approved as of December 9, 2004; June 9, 2005, for products with annual sales less than $25,000.
(6)Cold, cough, allergy, bronchodilator, and antiasthmatic drug products -
(i)Antihistamine drug products -
(A)Ingredients.
(B)Ingredients.
(ii)Nasal decongestant drug products -
(A)Approved as of May 7, 1991.
(B)Approved as of August 23, 1995.
(iii)Expectorant drug products.
(iv)Bronchodilator drug products -
(A)Approved as of October 2, 1987.
(7)Dandruff/seborrheic dermatitis/psoriasis drug products.
(8)Digestive aid drug products -
(ii)Approved as of November 10, 1993.
(10)External analgesic drug products -
(i)Analgesic and anesthetic drug products.
(ii)Counterirritant drug products.
(iii)Male genital desensitizer drug products.
(iv)Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.
(v)Fever blister and cold sore treatment drug products.
(vi)Insect bite and sting drug products.
(vii)Poison ivy, poison oak, and poison sumac drug products.
(12)Laxative drug products - (i)(A) Bulk laxatives.
(B)Bulk laxatives - Approved as of March 29, 2007.
(ii)Saline laxative.
(iii)Stool softener.
(A)Stimulant laxatives - Approved as of May 7, 1991.
(B)Stimulant laxatives - Approved as of January 29, 1999.
(C)Stimulant laxatives - Approved as of November 5, 2002.
(14)Oral health care drug products (nonantimicrobial).
(15)Topical otic drug products -
(i)For the prevention of swimmer's ear and for the drying of water-clogged ears, approved as of May 7, 1991.
(ii)For the prevention of swimmer's ear, approved as of August 15, 1995.
(16)Poison treatment drug products.
(17)Skin bleaching drug products.
(18)Skin protectant drug products - (i)(A) Ingredients - Approved as of May 7, 1991.
(B)Ingredients - Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000.
(ii)Astringent drug products.
Calcium acetate (except calcium acetate monohydrate when combined with aluminum sulfate tetradecahydrate to provide an aluminum acetate solution as described in § 347.20(b) of this chapter)
(iii)Diaper rash drug products.
(iv)Fever blister and cold sore treatment drug products.
(v)Insect bite and sting drug products -
(A)Ingredients - Approved as of November 10, 1993.
(vi)Poison ivy, poison oak, and poison sumac drug products -
(20)Weight control drug products.
(21)Ophthalmic drug products.
(i)Ophthalmic anesthetic drug products.
(ii)Ophthalmic anti-infective drug products.
(iii)Ophthalmic astringent drug products.
(iv)Ophthalmic demulcent drug products.
(v)Ophthalmic vasoconstrictor drug products.
(22)Topical antifungal drug products.
(i)Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash.
(ii)Ingredients.
(iv)Ingredients.
(23)Internal analgesic drug products -
(i)Approved as of November 10, 1993.
(ii)Approved as of February 22, 1999.
(24)Orally administered menstrual drug products -
(25)Pediculicide drug products -
(ii)Approved as of June 14, 1994. The combination of pyrethrum extract (formerly named pyrethrins) and piperonyl butoxide in an aerosol dosage formulation.
(26)Anorectal drug products -
(i)Anticholinergic drug products.
(ii)Antiseptic drug products.
(iii)Astringent drug products.
(iv)Counterirritant drug products.
(v)Keratolytic drug products.
(vi)Local anesthetic drug products.
(vii)Other drug products.
(viii)Protectant drug products.
(ix)Vasoconstrictor drug products.
(x)Wound healinq drug products.
(xi)Combination drug products. Any combination drug product containing hydrocortisone and pramoxine hydrochloride.
(27)Topical antimicrobial drug products -
(i)First aid antiseptic drug products.
(ii)Diaper rash drug products.
(28)Vaginal contraceptive drug products -
(i)Approved as of October 22, 1998.
(ii)Approved as of November 5, 2002.
(29)Sunscreen drug products.
(i)Ingredients.
(d) Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(39) of this section.
(3) December 4, 1992, for products subject to paragraph (a)(7) of this section that contain menthol as an antipruritic in combination with the antidandruff ingredient coal tar identified in § 358.710(a)(1) of this chapter. This section does not apply to products allowed by § 358.720(b) of this chapter after April 5, 2007.
(39) September 6, 2010, for products subject to paragraph (a)(18)(ii) of this section that contain calcium acetate monohydrate, except as provided in § 347.20(b) of this chapter.
[ 55 FR 46919, Nov. 7, 1990]
For Federal Register citations affecting § 310.545, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
At 61 FR 9571, Mar. 8, 1996, in § 310.545 in paragraph (a)(6)(ii)(B), the entry for “l-desoxyephedrine (topical)” was stayed until further notice.
§ 242 - Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States
21 CFR 201.319 — Water-Soluble Gums, Hydrophilic Gums, and Hydrophilic Mucilloids (Including, but Not Limited to Agar, Alginic Acid, Calcium Polycarbophil, Carboxymethylcellulose Sodium, Carrageenan, Chondrus, Glucomannan ((B-1,4 Linked) Polymannose Acetate), Guar Gum, Karaya Gum, Kelp, Methylcellulose, Plantago Seed (Psyllium), Polycarbophil Tragacanth, and Xanthan Gum) as Active Ingredients; Required Warnings and Directions.