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November 17, 2015
Honorable Jason M. Lewis, Senate Chair
Joint Committee on Public Health
State House Room 511B
Boston, MA 02133
Honorable Kate Hogan, House Chair
Joint Committee on Public Health
State House, Room 130
Boston, MA 02133
Re: Testimony in support of H.2061: An Act Relative to Expanding Veterinary Treatment
Practices
Dear Chairman Lewis, Chairwoman Hogan, and honored members of the committee:
The Massachusetts Pharmacists Association (MPhA), representing the interests of pharmacists
from all practice settings, and the Massachusetts Independent Pharmacists Association,
representing the interests of Independent Pharmacies in the Commonwealth offer our support
along with recommendations to amend H.2061.
The Associations agree with the premise and purpose of this bill: Veterinarians are in need of
certain compounded medications for “office use” to treat animals with emergent conditions; and
amendments to provisions created by Chapter 159 of the Acts of 2014 are required to permit a
compounding pharmacy to engage in non-prescription specific, anticipatory compounding if it is
to be the source of these medications.
The associations request that the Committee consider the following recommendations prior to
taking action on this bill:
1. As an alternative to a change in the definition of compounding, the Massachusetts Board
of Registration in Pharmacy (MA BORP) could be authorized to grant waivers to sterile
and complex non-sterile compounding pharmacies licensed by the state of Massachusetts
to supply licensed veterinarians with approved emergent compounded medications for
office use.
2. The Boards of Pharmacy and Veterinary Medicine should be required to promulgate joint
regulations to enact this law that include the following:
a. A process for the creation of a list of compounded medications necessary to
address emergent situations and a process by which this list can be amended.
b. A requirement that veterinarians follow Board of Registration in Pharmacy
guidelines for drug storage including temperature and humidity monitoring to
protect pharmacies from unwarranted claims of improperly compounded
medications. These veterinarians shall be subject to inspection by the MA
BORP for appropriate drug storage only.
c. A requirement that the Veterinary practice be required to provide the
pharmacy with timely and accurate records accounting for all compounded
medications received.
Our interpretation of federal policy suggests that compounding animal drugs for office use does
not run afoul of federal laws or regulation, nor would it require registration with the Food and
Drug Administration (FDA) as required by M.G.L. subsection (c) of section 39F of Chapter 112.
This subsection states:
An entity that intends to compound and distribute a sterile drug preparation or a
complex non-sterile drug preparation to pharmacies, wholesalers or prescribers within
or outside of the commonwealth: (i) in anticipation of a prescription… shall adhere to
the most current standards established under cGMP when engaging in any form of
compounding. Such pharmacies shall obtain and hold a manufacturer’s license
appropriate to this practice, from the federal Food and Drug Administration, before
engaging in any sterile compounding or complex non-sterile compounding.
The FDA, which has long held that non-prescription anticipatory compounding to be illegal in
the absence of a manufacturer’s license, now provides an alternative to a manufacturer’s license
for compounding pharmacies engaged in this activity. Under the recently enacted section 503B
of the federal Food, Drug, and Cosmetic (FDC) Act, the FDA calls for these pharmacies to
voluntarily register as “Outsourcing Facilities”. However, an FDA guidance Q&A states that a
facility that engages in this activity only for animal drugs should not register as an Outsourcing
Facility because the drugs it produces will not be eligible for the statutory exemptions described
in section 503B of the FDC Act. In essence, the FDA has chosen to put the onus of regulation
and oversight for compounding for office use for animal drugs solely on the states.
Therefore, in the interest of providing veterinarians with medications needed to properly treat
animals in emergent conditions, we ask the Committee to amend and move this important bill
forward with a favorable recommendation.
Sincerely,
David Johnson
Executive Vice President, MPhA
Todd Brown,
Executive Director, MIPA