[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: 21CFR500.55]

[Page 11]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
              Subpart C--Animal Drug Labeling Requirements
 
Sec.  500.55  Exemption from certain drug-labeling requirements.

    (a) Section 201.105(c) of this chapter provides that in the case of 
certain drugs for which directions, hazards, warnings, and use 
information are commonly known to practitioners licensed by law, such 
information may be omitted from the dispensing package. Under this 
proviso, the Commissioner of Food and Drugs will offer an opinion, upon 
written request, stating reasonable grounds therefore on a proposal to 
omit such information from the dispensing package.
    (b) The Commissioner of Food and Drugs has considered submitted 
material covering a number of drug products and has offered the opinion 
that the following drugs when intended for those veterinary uses for 
which they are now generally employed by the veterinary medical 
profession, should be exempt from the requirements of Sec.  201.105(c) 
of this chapter, provided that they meet the conditions prescribed in 
this paragraph. Preparations that are not in dosage unit form (for 
example, solutions) will be regarded as meeting the conditions with 
respect to the maximum quantity of drug per dosage unit if they are 
prepared in a manner that enables accurate and ready administration of a 
quantity of drug not in excess of the stated maximum per dosage unit:

Atropine sulfate. As an injectable for cattle, goats, horses, pigs, and 
sheep, not in excess of 15 milligrams per dosage unit; as an injectable 
for cats and dogs, not in excess of 0.6 milligram per dosage unit.
Barbital sodium. For oral use in cats and dogs, not in excess of 300 
milligrams per dosage unit.
Epinephrine injection. 1:1,000. For cats, dogs, cattle, goats, horses, 
pigs, and sheep (except as provided in Sec.  500.65).
Morphine sulfate. As an injectable for dogs, not in excess of 15 
milligrams per dosage unit.
Pentobarbital sodium. For oral use in cats and dogs, not in excess of 
100 milligrams per dosage unit.
Phenobarbital sodium. For oral use in cats and dogs, not in excess of 
100 milligrams per dosage unit.
Procaine hydrochloride injection. Containing not in excess of 2 percent 
procaine hydrochloride, with or without epinephrine up to a 
concentration of 1:50,000. For use in cats, dogs, cattle, goats, horses, 
pigs, and sheep.
Thyroid. For oral use in dogs, not in excess of 60 milligrams per dosage 
unit.