Relates to compounding, dispensing and sale of pharmaceuticals for veterinary use either by administration in a veterinary facility or by dispensing to the owner of an animal in certain circumstances.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A8167
SPONSOR: Farrell TITLE OF BILL:
An act to amend the education law, in relation to the compounding,
dispensing and sale of pharmaceuticals
PURPOSE OR GENERAL IDEA OF BILL:
The bill is designed to allow pharmacists to compound limited quantities
for dispensing in veterinary facilities despite the ban on pharmaceu-
tical dispensing for human purposes.
SUMMARY OF SPECIFIC PROVISIONS:
The bill adds a new paragraph 15 to section 6810 of the education law to
allow pharmacists to compound strictly limited amounts of substances for
veterinary facilities that they may in turn dispense to animals with
which they have a veterinary patient relationship under certain limited
circumstances.
JUSTIFICATION:
Following incidents in which compounded pharmaceuticals resulted in
serious injury and deaths to humans compounding pharmacies were prohib-
ited from continuing to engage in this activity. At the same time this
prohibition directed at human health has resulted in compounding pharma-
cies refusing to compound veterinary pharmaceuticals out of uncertainty
regarding their legal ability to do so. A number of states have acted to
enact specific legislation that would specify that pharmacists legally
may engage in this activity under limited circumstances. The Food and
Drug Administration has become involved to ensure that state actions
remain permissible under its view of this issue, something that this
bill does.
Unlike human medicine, veterinary medicine has a unique service model.
In many cases there is no ready alternative to a veterinarian having
compounded medicines on hand at all times. This is especially true in
emergency situations and at night and on weekends and holidays where
there is no practical alternative but the animal hospital and its staff
veterinarians for the purposes of filling a prescription for an animal
with which a veterinary client patient relationship exists. The alter-
native to the safe and proper use of these safe substances would in many
cases be suffering and possible death for the animal in need of them.
This bill provides recommended safeguards by strictly limiting the quan-
tities of compounded pharmaceuticals that a practice may have on hand
very strictly to a short term supply of 100 doses or twelve ounces of
liquid medications, twelve ophthalmic, topical or inhaled preparations
and 100 ml of sterile injectable solutions. This will ensure that only
wholesome substances are prescribe and are always fresh and efficacious.
PRIOR LEGISLATIVE HISTORY:
New bill.
FISCAL IMPLICATIONS:
None.
EFFECTIVE DATE:
This act shall take effect 180 days after becoming a law.
STATE OF NEW YORK
________________________________________________________________________
8167
2015-2016 Regular Sessions
IN ASSEMBLY
June 10, 2015
___________
Introduced by M. of A. FARRELL -- read once and referred to the Commit-
tee on Higher Education
AN ACT to amend the education law, in relation to the compounding,
dispensing and sale of pharmaceuticals
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Section 6810 of the education law is amended by adding a
2 new subdivision 15 to read as follows:
3 15. A pharmacist may engage in the compounding of drug products for
4 veterinary use either by administration in a veterinary facility or by
5 dispensing to the owner of an animal when such dispensing is (a) to an
6 animal with which a veterinarian has an existing veterinary client
7 patient relationship, (b) consistent with the requirements of law
8 regarding the writing of prescriptions and dispensing of drug products,
9 (c) the compounded drug is for the treatment of an emergency situation,
10 (d) the compounded drug is dispensed by a veterinarian in accordance
11 with the provisions of law including provisions regarding the adminis-
12 tration of pharmaceuticals to animals intended for human consumption and
13 (e) the dispensing veterinarian maintains in the animal's medical histo-
14 ry the name of the compounding pharmacy, the batch numbers of the prod-
15 uct dispensed and the quantity dispensed. For the purposes of this
16 section "compounding" means the combination of two or more ingredients
17 to fabricate such ingredients into a single preparation and includes the
18 mixing, assembling, packaging and labeling of such preparation. Notwith-
19 standing the foregoing, no pharmacist may compound quantities for a
20 single facility in excess of one hundred oral doses or twelve ounces of
21 liquid medications, twelve ophthalmic, topical or inhaled preparations
22 or one hundred ml of sterile injectable preparation in a single order.
23 § 2. This act shall take effect on the one hundred eightieth day after
24 it shall have become a law.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD11589-01-5
