21 CFR 522.778 - Doxycycline hyclate.

§ 522.778 Doxycycline hyclate.
(a) Specifications. Doxycycline hyclate solution contains 8.5 percent doxycycline activity. A syringe of N-methyl-2-pyrrolidone and poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5 milliliter of solution.
(b) Sponsor. See 000009 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use—
(1) Dogs—
(i) Amount. Apply subgingivally to periodontal pocket(s) of affected teeth.
(ii) Indications for use. For treatment and control of periodontal disease.
(iii) Limitations. Do not use in dogs less than 1-year old. Use of tetracyclines during tooth development has been associated with permanent discoloration of teeth. Do not use in pregnant bitches. Use in breeding dogs has not been evaluated. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[63 FR 8349, Feb. 19, 1998, as amended at 65 FR 45878, July 26, 2000]
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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

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 522 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558