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Outside Section 78
Data Current as of:  8/9/2016




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Compounded Medications for Companion Animals

SECTION 78.   Said chapter 112 is hereby further amended by inserting after section 58A the following section:-

Section 58A1/2. (a) For the purposes of this section, the following words shall have the following meaning unless the context clearly requires otherwise:

"Companion animal", a domesticated animal including, but not limited to, fowl, birds, fish or reptiles; provided, however, that "companion animal" shall not include animals intended for consumption or whose products are intended for consumption by humans or other animals.

"Compounded drug", a drug formulation distributed from a pharmacy that has been prepared, mixed or assembled for use on or for a companion animal to meet the unique medical need of a companion animal as determined by the prescribing veterinarian including, but not limited to, the removal of a dye for medical reasons, a change in strength, the addition of a flavor or a change in dosage, form or delivery mechanism.

(b) A veterinarian may dispense a compounded drug to a companion animal if: (i) the companion animal is a patient within a valid veterinarian-client-patient relationship, as defined in the principles of veterinary medical ethics established by the American Veterinary Medical Association; (ii) the quantity dispensed does not exceed a 120 hour supply; (iii) the compounded drug is for the treatment of an emergency condition; and (iv) timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian.

(c) Pharmacists shall label all compounded products for companion animals distributed to a veterinarian for further distribution or sale and shall include: (i) the name and strength of the compounded medication or list of the active ingredients and strengths; (ii) the facility's control number; (iii) an appropriate beyond-use date as determined by the pharmacist in compliance with the United States Pharmacopeia and the National Formulary standards for pharmacy compounding; (iv) the name and address of the pharmacy; and (v) the quantity.