C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart D—Exemptions From Adequate Directions for Use

21 C.F.R. § 201.122

Drugs for processing, repacking, or manufacturing

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A drug in a bulk package, except tablets, capsules, or other dosage unit forms, intended for processing, repacking, or use in the manufacture of another drug shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”; and if in substantially all dosage forms in which it may be dispensed it is subject to section 503(b)(1) of the act, the statement “Rx only”, or if in substantially all dosage forms in which it may be dispensed it is subject to section 503(f)(1) of the act, the statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”. This exemption and the exemption under § 201.120 may be claimed for the same article. However, the exemption shall not apply to a substance intended for a use in manufacture, processing, or repacking which causes the finished article to be a new drug or new animal drug, unless:

(a) An approved new drug application or new animal drug application or a new animal drug index listing covers the production and delivery of the drug substance to the application or index listing holder by persons named in the application or in the request for determination of eligibility for indexing, and, for a new drug substance, the export of it by such persons under § 314.410 of this chapter; or

(b) If no application is approved with respect to such new drug or new animal drug, and it is not listed in the index, the label statement “Caution: For manufacturing, processing, or repacking” is immediately supplemented by the words “in the preparation of a new drug or new animal drug limited by Federal law to investigational use”, and the delivery is made for use only in the manufacture of such new drug or new animal drug limited to investigational use as provided in part 312 or § 511.1 or § 516.125 of this chapter; or

(c) A new drug application or new animal drug application or a request for addition to the index covering the use of the drug substance in the production and marketing of a finished drug product has been submitted but not yet approved, disapproved, granted, or denied, the bulk drug is not exported, and the finished drug product is not further distributed after it is manufactured until after the new drug application or new animal drug application is approved or the request for addition to the index is granted.

[41 FR 6911, Feb. 13, 1976, as amended at 41 FR 15844, Apr. 15, 1976; 50 FR 7492, Feb. 22, 1985; 55 FR 11576, Mar. 29, 1990; 57 FR 54301, Nov. 18, 1992; 67 FR 4906, Feb. 1, 2002; 72 FR 69119, Dec. 6, 2007]
Notes of Decisions
Cited in 14 cases, 1986–2011 · leading case: White v. Weiner, 562 A.2d 378 (Pa. 1989).
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White v. Weiner, 562 A.2d 378 (Pa. 1989). · cites it 5× “As directed 21 C.F.R. § 201.122 (1982) specifically exempts from labeling requirements.”
United States v. Algon Chem. Inc., a Corp., & Edward Latinsky, an Individual, 879 F.2d 1154 (3rd Cir. 1989). · cites it 4× “In an exercise of that authority, the FDA in 1952 promulgated a number of exemption provisions, including the predecessor of what is now 21 C.F.R. § 201.122 , which provides an exemption from the labeling requirements for the sale of bulk drugs.”
Med. Ctr. Pharmacy v. Mukasey, 536 F.3d 383 (5th Cir. 2008). “” An FDA regulation, 21 C.F.R. § 201.122 (2008), exempts from the misbranding requirement bulk drugs used to manufacture other animal drugs, so long as the finished product is not a unapproved "new drug.”
United States v. Algon Chem. Inc., 689 F. Supp. 394 (D.N.J. 1988). · cites it 10× “The defendant, Algon, argues that the 13 lots of drugs are exempt from the labeling requirements of § 352(f)(1) of the Act by virtue of an exempting regulation, 21 C.F. R. § 201.122. Additionally, defendant argues that the same exempting regulation serves to make § 321(w)(3)…”
United States v. 9/1 KG Containers, More or Less of an Article of Drug for Veterinary Use, 674 F. Supp. 1344 (C.D. Ill. 1987). · cites it 4× “21 C.F.R. § 201.122 (1987). It is the Government’s contention that the limitation on the exemption (“But the exemption shall not apply .”
Med. Ctr. Pharmacy v. Gonzales, 451 F. Supp. 2d 854 (W.D. Tex. 2006). · cites it 2× “The regulation found at 21 C.F.R. § 201.122 exempts bulk ingredients from the Act’s adequate directions for use requirement unless the finished product is a new drug.”
United States v. Articles of Drug, 634 F. Supp. 435 (N.D. Ill. 1986). · cites it 2× “The regulation which the Government for the first time cites as stating the firm order policy, 21 C.F.R. § 201.122 , is inapposite. That regulation merely states the conditions for exemption from labeling requirements; it does not embody the firm order/matching letter policy.”
Fisher v. Prof'l Compounding Centers of Am., Inc., 311 F. Supp. 2d 1008 (D. Nev. 2004). “”); 21 C.F.R. § 201.122 (regulation exempting bulk suppliers from labeling requirements).”
United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). · cites it 2× “Containers each addressed the enforceability of an FDA regulation that exempted bulk drug sales from the FDCA’s labeling requirements but limited the exemption to holders of new drug approval applications, thereby excluding veterinarians from the exemption.”
United States v. 9/1 Kg. Containers, More or Less, of an Article of Drug for Veterinary Use, 854 F.2d 173 (7th Cir. 1988). “21 C.F.R. § 201.122 . Schuyler’s bulk drugs do not qualify under this regulation as written, because although they are “intended for use in manufacture” (etc.”
United States v. Undetermined Quantities of Articles of Drug, 145 F. Supp. 2d 692 (D. Maryland 2001). “See 21 C.F.R. § 201.122 . Therefore, for the above discussed reasons, the Court finds the Defendants’ products to be misbranded under § 352(f) of the FDCA.”
Boswell v. Iowa Bd. of Veterinary Med., 477 N.W.2d 366 (Iowa 1991). “section 352 (f) and 21 C.F.R. section 201.122 lawfully restrict the sale of bulk drugs that can be used to produce “new” drugs to firms that hold approved new animal drug permits.”
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