21 C.F.R. § 314.420

Drug master files

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(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigational new drug application under part 312 or submits an application or an abbreviated application or an amendment or supplement to them under this part, or to permit the holder to authorize other persons to rely on the information to support a submission to FDA without the holder having to disclose the information to the person. FDA ordinarily neither independently reviews drug master files nor approves or disapproves submissions to a drug master file. Instead, the agency customarily reviews the information only in the context of an application under part 312 or this part. A drug master file may contain information of the kind required for any submission to the agency, including information about the following:

(1) [Reserved]

(2) Drug substance, drug substance intermediate, and materials used in their preparation, or drug product;

(3) Packaging materials;

(4) Excipient, colorant, flavor, essence, or materials used in their preparation;

(5) FDA-accepted reference information. (A person wishing to submit information and supporting data in a drug master file (DMF) that is not covered by Types II through IV DMF's must first submit a letter of intent to the Drug Master File Staff, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.) FDA will then contact the person to discuss the proposed submission.

(b) An investigational new drug application or an application, abbreviated application, amendment, or supplement may incorporate by reference all or part of the contents of any drug master file in support of the submission if the holder authorizes the incorporation in writing. Each incorporation by reference is required to describe the incorporated material by name, reference number, volume, and page number of the drug master file.

(c) A drug master file is required to be submitted in two copies. The agency has prepared guidance that provides information about how to prepare a well-organized drug master file. If the drug master file holder adds, changes, or deletes any information in the file, the holder shall notify in writing, each person authorized to reference that information. Any addition, change, or deletion of information in a drug master file (except the list required under paragraph (d) of this section) is required to be submitted in two copies and to describe by name, reference number, volume, and page number the information affected in the drug master file.

(d) The drug master file is required to contain a complete list of each person currently authorized to incorporate by reference any information in the file, identifying by name, reference number, volume, and page number the information that each person is authorized to incorporate. If the holder restricts the authorization to particular drug products, the list is required to include the name of each drug product and the application number, if known, to which the authorization applies.

(e) The public availability of data and information in a drug master file, including the availability of data and information in the file to a person authorized to reference the file, is determined under part 20 and § 314.430.

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 53 FR 33122, Aug. 30, 1988; 55 FR 28380, July 11, 1990; 65 FR 1780, Jan. 12, 2000; 65 FR 56479, Sept. 19, 2000; 67 FR 9586, Mar. 4, 2002; 69 FR 13473, Mar. 23, 2004]

Notes of Decisions

Cited in 5 cases (2 in the last 5 years), 2002–2025 · leading case: Shire LLC v. Amneal Pharm., LLC, 802 F.3d 1301 (Fed. Cir. 2015).

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Shire LLC v. Amneal Pharm., LLC, 802 F.3d 1301 (Fed. Cir. 2015). “Johnson Mat-they supplied LDX dimesylate to the ANDA defendants and correspondingly filed a drug master file with the FDA, see 21 C.F.R. § 314.420 , but did not itself file an ANDA.”

SmithKline Beecham Corp. v. Geneva Pharm., Inc., 287 F. Supp. 2d 576 (E.D. Pa. 2002). “21 C.F.R. § 314.420 . 7 . In Civil Action No.”

Fresenius Kabi USA LLC v. Par Sterile Prods. LLC (3rd Cir. 2021). · cites it 2× “1 See 21 C.F.R. § 314.420 (a). This allows an API supplier to support the manufacturer’s application without revealing to the manufacturer confidential proprietary information.”

Pfizer Inc. & Tris Pharma, Inc. v. the State of Texas & Tarik Ahmed (Tex. App. 2025). · cites it 2× “24, 25, 26 21 C.F.R. § 314.420 .....................”

Otsuka Pharm. Co., Ltd. v. Hetero Labs Ltd. (D. Del. 2020). “See 21 C.F.R. § 314.420 (a). ? To state a claim for relief, Federal Rule of Civil Procedure 8(a) requires that a complaint need only include a short and plain state of the claim, showing that the pleader is entitled to relief, in order to give the defendant fair notice of what…”

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