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Submitted URL: https://www.ecfr.gov/current/title-21/section-601.2#p-601.2
Effective URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601/subpart-A/section-601.2
Submission: On March 28 via manual from DE — Scanned from DE
Effective URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601/subpart-A/section-601.2
Submission: On March 28 via manual from DE — Scanned from DE
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ECFR
THE ELECTRONIC CODE OF FEDERAL REGULATIONS
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TITLE 21
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1. Title 21 —Food and Drugs
2. Chapter I —Food and Drug Administration, Department of Health and Human
Services
3. Subchapter F —Biologics
4. Part 601 —Licensing
5. Subpart A —General Provisions
6. § 601.2
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URL https://www.ecfr.gov/current/title-21/part-601/section-601.2 Citation 21
CFR 601.2 Agency Food and Drug Administration, Department of Health and Human
Services
--------------------------------------------------------------------------------
Part 601
AUTHORITY:
15 U.S.C. 1451–1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f,
360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122,
Pub. L. 105–115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L.
111–148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116–94,
133 Stat. 3127.
SOURCE:
38 FR 32052, Nov. 20, 1973, unless otherwise noted.
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ECFR CONTENT
The Code of Federal Regulations (CFR) is the official legal print publication
containing the codification of the general and permanent rules published in the
Federal Register by the departments and agencies of the Federal Government. The
Electronic Code of Federal Regulations (eCFR) is a continuously updated online
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Learn more about the eCFR, its status, and the editorial process.
§ 601.2 APPLICATIONS FOR BIOLOGICS LICENSES; PROCEDURES FOR FILING.
(a) General. To obtain a biologics license under section 351 of the Public
Health Service Act for any biological product, the manufacturer shall submit an
application to the Director, Center for Biologics Evaluation and Research or the
Director, Center for Drug Evaluation and Research (see mailing addresses in §
600.2(a) or (b) of this chapter), on forms prescribed for such purposes, and
shall submit data derived from nonclinical laboratory and clinical studies which
demonstrate that the manufactured product meets prescribed requirements of
safety, purity, and potency; with respect to each nonclinical laboratory study,
either a statement that the study was conducted in compliance with the
requirements set forth in part 58 of this chapter, or, if the study was not
conducted in compliance with such regulations, a brief statement of the reason
for the noncompliance; statements regarding each clinical investigation
involving human subjects contained in the application, that it either was
conducted in compliance with the requirements for institutional review set forth
in part 56 of this chapter; or was not subject to such requirements in
accordance with § 56.104 or § 56.105, and was conducted in compliance with
requirements for informed consent set forth in part 50 of this chapter. A full
description of manufacturing methods; data establishing stability of the product
through the dating period; sample(s) representative of the product for
introduction or delivery for introduction into interstate commerce; summaries of
results of tests performed on the lot(s) represented by the submitted sample(s);
specimens of the labels, enclosures, and containers, and if applicable, any
Medication Guide required under part 208 of this chapter proposed to be used for
the product; and the address of each location involved in the manufacture of the
biological product shall be listed in the biologics license application. The
applicant shall also include a financial certification or disclosure
statement(s) or both for clinical investigators as required by part 54 of this
chapter. An application for a biologics license shall not be considered as filed
until all pertinent information and data have been received by the Food and Drug
Administration. The applicant shall also include either a claim for categorical
exclusion under § 25.30 or § 25.31 of this chapter or an environmental
assessment under § 25.40 of this chapter. The applicant, or the applicant's
attorney, agent, or other authorized official shall sign the application. An
application for any of the following specified categories of biological products
subject to licensure shall be handled as set forth in paragraph (c) of this
section:
(1) Therapeutic DNA plasmid products;
(2) Therapeutic synthetic peptide products of 40 or fewer amino acids;
(3) Monoclonal antibody products for in vivo use; and
(4) Therapeutic recombinant DNA-derived products.
(b) [Reserved]
(c)
(1) To obtain marketing approval for a biological product subject to licensure
which is a therapeutic DNA plasmid product, therapeutic synthetic peptide
product of 40 or fewer amino acids, monoclonal antibody product for in vivo use,
or therapeutic recombinant DNA-derived product, an applicant shall submit a
biologics license application in accordance with paragraph (a) of this section
except that the following sections in parts 600 through 680 of this chapter
shall not be applicable to such products: §§ 600.10(b) and (c), 600.11, 600.12,
600.13, 610.53, and 610.62 of this chapter.
(2) To the extent that the requirements in this paragraph (c) conflict with
other requirements in this subchapter, this paragraph (c) shall supersede other
requirements.
(d) Approval of a biologics license application or issuance of a biologics
license shall constitute a determination that the establishment(s) and the
product meet applicable requirements to ensure the continued safety, purity, and
potency of such products. Applicable requirements for the maintenance of
establishments for the manufacture of a product subject to this section shall
include but not be limited to the good manufacturing practice requirements set
forth in parts 210, 211, 600, 606, and 820 of this chapter.
(e) Any establishment and product license for a biological product issued under
section 351 of the Public Health Service Act (42 U.S.C. 201 et seq.) that has
not been revoked or suspended as of December 20, 1999, shall constitute an
approved biologics license application in effect under the same terms and
conditions set forth in such product license and such portions of the
establishment license relating to such product.
(f) Withdrawal from sale of approved biological products. A holder of a
biologics license application (BLA) must report to FDA, in accordance with the
requirements of §§ 207.61 and 207.65, the withdrawal from sale of an approved
biological product. The information must be submitted to FDA within 30 working
days of the biological product's withdrawal from sale. The following information
must be submitted: The holder's name; product name; BLA number; the National
Drug Code; and the date on which the product is expected to be no longer in
commercial distribution. The reason for the withdrawal of the biological product
is requested but not required to be submitted.
(g) Master files —
(1) Biologics license applications under section 351 of the Public Health
Service Act not permitted to incorporate by reference drug substance, drug
substance intermediate, or drug product information contained in a master file.
Except as provided in paragraphs (g)(2) and (3) of this section, a biologics
license application under section 351 of the Public Health Service Act may not
incorporate by reference drug substance, drug substance intermediate, or drug
product information contained in a master file, including a drug master file
submitted under § 314.420 of this chapter, for the product, including for a
biological product constituent part of a combination product.
(2) Former approved applications deemed to be licenses for biological products
pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation
Act of 2009. An application for a biological product that:
(i) Is a former approved application under section 505 of the Federal Food,
Drug, and Cosmetic Act that, pursuant to section 7002(e)(4) of the Biologics
Price Competition and Innovation Act of 2009, has been deemed to be a license
for the biological product under section 351 of the Public Health Service Act;
and
(ii) At the time it was so deemed, incorporated by reference drug substance,
drug substance intermediate, and/or drug product information contained in a drug
master file submitted under § 314.420 of this chapter, may continue to
incorporate by reference the information contained in that drug master file.
Amendments and supplements to such applications may also continue to incorporate
by reference the information contained in that drug master file.
(3) Non-biological product constituent parts of combination products regulated
under biologics license applications under section 351 of the Public Health
Service Act. A biologics license application under section 351 of the Public
Health Service Act may incorporate by reference drug substance, drug substance
intermediate, and/or drug product information contained in a master file,
including a drug master file submitted under § 314.420 of this chapter, for any
non-biological product constituent part of a combination product.
(4) Biologics license applications under section 351 of the Public Health
Service Act permitted to incorporate by reference information contained in a
master file that is not drug substance, drug substance intermediate, or drug
product information. Nothing in paragraph (g)(1) of this section limits or
restricts a biologics license application under section 351 of the Public Health
Service Act from incorporating by reference information contained in any master
file, including a drug master file submitted under § 314.420 of this chapter,
that is not drug substance, drug substance intermediate, or drug product
information.
(5) Investigational new drug applications. Nothing in paragraph (g)(1) of this
section limits or restricts an investigational new drug application for a
product that would be subject to licensure under section 351 of the Public
Health Service Act from incorporating by reference any information, including
drug substance, drug substance intermediate, and drug product information,
contained in a master file, including a drug master file submitted under §
314.420 of this chapter.
[64 FR 56450, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005; 80 FR
18092, Apr. 3, 2015; 80 FR 37974, July 2, 2015; 81 FR 60221, Aug. 31, 2016; 89
FR 9756, Feb. 12, 2024]
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