[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.778]

[Page 235]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  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 Sec.  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]