21 CFR 529.1186 - Isoflurane. | Title 21 - Food and Drugs | Code of Federal Regulations

§ 529.1186

Isoflurane.

(a) Specifications. The drug is a clear, colorless, stable liquid.

(b) Sponsors. See Nos. 000074, 000209, 010019, 012164, 065085, and 066794 in § 510.600(c) of this chapter.

(c) Conditions of use. Administer by inhalation:

(1) Amount— (i) Horses: For induction of surgical anesthesia: 3 to 5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).

(ii) Dogs: For induction of surgical anesthesia: 2 to 2.5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).

(2) Indications for use. For induction and maintenance of general anesthesia in horses and dogs.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 FR 16533, Mar. 24, 2011]

Title 21 published on 2012-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2013-04-09; vol. 78 # 68 - Tuesday, April 9, 2013

78 FR 21058 - New Animal Drugs; Change of Sponsor

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-07542
RIN
Docket No.	FDA-2013-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective April 9, 2013.

21 CFR Parts 510, 520, 522, 524, 526, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.

2013-03-25; vol. 78 # 57 - Monday, March 25, 2013

78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06748
RIN
Docket No.	FDA-2013-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective March 25, 2013.

21 CFR Parts 510, 522, 524, and 529

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.

2013-03-22; vol. 78 # 56 - Friday, March 22, 2013

78 FR 17595 - New Animal Drugs; Changes of Sponsor

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06126
RIN
Docket No.	FDA-2013-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective March 22, 2013.

21 CFR Parts 510, 520, 522, 524, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.

2013-03-07; vol. 78 # 45 - Thursday, March 7, 2013

78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N -Butyl Chloride; Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-04999
RIN
Docket No.	FDA-2012-N-1167

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule, technical amendment.

This rule is effective March 18, 2013.

21 CFR Parts 510, 520, 522, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.

2012-12-31; vol. 77 # 250 - Monday, December 31, 2012

77 FR 76862 - New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-31397
RIN
Docket No.	FDA-2012-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective December 31, 2012.

21 CFR Parts 520, 522, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.

2012-10-23; vol. 77 # 205 - Tuesday, October 23, 2012

77 FR 64715 - New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-25989
RIN
Docket No.	FDA-2012-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective October 23, 2012.

21 CFR Parts 510, 522, 524, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.

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.

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 529 after this date.

2013-04-09; vol. 78 # 68 - Tuesday, April 9, 2013

78 FR 21058 - New Animal Drugs; Change of Sponsor

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-07542
RIN
Docket No.	FDA-2013-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective April 9, 2013.

21 CFR Parts 510, 520, 522, 524, 526, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.

2013-03-25; vol. 78 # 57 - Monday, March 25, 2013

78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06748
RIN
Docket No.	FDA-2013-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective March 25, 2013.

21 CFR Parts 510, 522, 524, and 529

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.

2013-03-22; vol. 78 # 56 - Friday, March 22, 2013

78 FR 17595 - New Animal Drugs; Changes of Sponsor

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-06126
RIN
Docket No.	FDA-2013-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective March 22, 2013.

21 CFR Parts 510, 520, 522, 524, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.

2013-03-07; vol. 78 # 45 - Thursday, March 7, 2013

78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N -Butyl Chloride; Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-04999
RIN
Docket No.	FDA-2012-N-1167

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule, technical amendment.

This rule is effective March 18, 2013.

21 CFR Parts 510, 520, 522, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.

2012-12-31; vol. 77 # 250 - Monday, December 31, 2012

77 FR 76862 - New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-31397
RIN
Docket No.	FDA-2012-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective December 31, 2012.

21 CFR Parts 520, 522, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.

2012-12-05; vol. 77 # 234 - Wednesday, December 5, 2012

77 FR 72254 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-29322
RIN	0910-AG17
Docket No.	FDA-2012-N-1067

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Submit either electronic or written comments by March 5, 2013. See section VI of this document for the proposed effective date of a final rule based on this proposed rule.

21 CFR Parts 500, 520, 522, 524, 529, 556, and 558

Summary

The Food and Drug Administration (FDA) is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, we are proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations.

2012-10-23; vol. 77 # 205 - Tuesday, October 23, 2012

77 FR 64715 - New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-25989
RIN
Docket No.	FDA-2012-N-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective October 23, 2012.

21 CFR Parts 510, 522, 524, 529, and 558

Summary

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor's name, and a change of sponsor's address.

21 CFR 529.1186 - Isoflurane.

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