21 CFR Part 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

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SUBPART A — General Provisions (§§ 299.3 - 299.5)

Authority:

21 U.S.C. 331, 351, 352, 355, 358, 360b, 371.

Source:

40 FR 14041, Mar. 27, 1975, unless otherwise noted.

Title 21 published on 2015-04-01.

No entries appear in the Federal Register after this date, for 21 CFR Part 299.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S. Code: Title 21 - FOOD AND DRUGS

§ 331 - Prohibited acts

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 358 - Authority to designate official names

§ 360b - New animal drugs

§ 371 - Regulations and hearings

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 299 after this date.

2015-08-28; vol. 80 # 167 - Friday, August 28, 2015

80 FR 52224 - Designation of Official Names and Proper Names for Certain Biological Products

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2015-21382
RIN	0910-AH25
Docket No.	FDA-2015-N-0648

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit either electronic or written comments on the proposed rule by November 12, 2015. See section IV of this document for the proposed effective date of any final rule that may publish based on this proposal.

21 CFR Part 299

Summary

The Food and Drug Administration (FDA) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo-filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.