COMPOUNDING FOR ANIMALS
ISSUE BRIEFlNG
EXECUTIVE SUMMARY
Since its inception in 1930, FDA has allowed pharmacists to compound medications from bulk
active pharmaceutical in gredients (APIs) for non food an imal s, including companion, exotic, and
perfonnance animals.
However, in July 2003, FDA abruptly reversed this policy without any indication of the
reasoning or justification behind the substantial policy reversal. FDA's new prohibition on
compounding for non food animals will adversely affect the health and well-being of many pets
and will have broad repercussions on many small businesses.
IACP has repeatedly attempted to negotiate with FDA on these polici es. However, the Agency
remains unmoved. FDA sent infonnation to State Boards of Pharmacy in April 2004 announcing
the initiation of an inspection campaign against pharmacies that compound for animals.
Developments of this nature make this issue increasingly urgent for pharmacists and
veterinar ians who provide care for an imal patients.
NECESSITY OF VETERINARY COMPOUNDING
IACP strongly supports the rights of pharmacists to compound for non food animals from bulk
ingredients. Such compounding is part of the fundamental, historical practice ofphannacy and
necessary to preserve the health and well-being of many companion, exotic, and performance
animals. Ifphannacists are limited to using FDA-approved, commercially available drugs, many
animals will die, go untreated, or su ffer needlessly.
There are many situations that may require pharmacists to compound medications from bulk
ingredients for animal patients, which may include:
I) Discontinued Products: Pharnlacists can compound commercial medications that have been
discontinued from the market, no! for reasons of safety or effectiveness, and that would
otherwise be unavailable;
2) Product Integrity: Pharnlacists use bulk APls to compound medications when using a
commercially available, fin ished product as the ingredient source could add unnecessary
excipients to the medication and increase the risk of contamination (e.g. sterile medications)
or yield a product which is not concentrated enough to offer proper compliance;
3) No Alternative Therapy: Pharmacists often compound medications using bulk APls when
there is no commercial alternative to treat the disease state or condition treated by the
compounded medication;
4) Patient Compliance: Pharmacists also compound some medications for animal patients to
make it eas ier for pet owners to administer medication to their pet, which often in vo lves
flavoring a medication or chan ging the dosage form.
FDA itself has repeatedly recognized the importance of compounding medications for an imals,
inasmuch as commercially available drugs significantly underserve animal patients.
Pharmacists, who can customize medications based on a veterinarian's prescription to meet an
animal's unique medication need, currently address this gap in medication access ibility.
IACP002716
However, pharmacists must have access to bulk APIs to continue meeting these needs and to
prevent the unnecessary suffering and harm of animals.
REGULATORY TIMELINE
1988 and 1989
The U.S. Food and Drug Administration (FDA) has long contended that compounding for
anima ls from bulk ingred ients is illegal. This position is supported by two U.S. Court of
Appeals' decisions: Uni ted States v. Algon Chemical Inc., 879 F.2d 1 154 (3d Cir. 1989) and
Uni ted States v. 9/1 Kg. Containers, 854 F.2d 173 (7th Cir. 1988). FDA argues that these cou,t
cases affirm its position that the Federal Food Drug & Cosmetic Act of 1938 (FDCA) does not
permit veterinarians to compound unapproved finished drug products from bulk ingredients,
un less the fi nished drug is not a new animal drug. FDA extends the principle established by the
court to compounding by pharmacists.
One of the COUIts specifically acknowledged the FDA's pol icy that, if the need is great and the
risk small, the FDA may exercise regulatory di scretion with respect to veterinarians
compounding from approved drugs. For many years, FDA has exercised regulatory discretion in
allowing compounding of medications from bulk ingredients for non food animals.
These two court cases are significant in that FDA cites them to support their theory that
compounding from bu lk drugs for animals is subject to FDA's enforcement discretion.
1994
Congress passed the Animal Medicinal Drug Use Clarification Act (AMDUCA) in October 1994
to allow and set parameters for extra label uses of approved animal drugs and approved human
drugs in an imals. The AMDUCA law does not contain any specific references to compounding.
1996
FDA issued fina l regulat ions implementing AMDUCA November 1996. Section 530. 13 of these
regulations sets parameters for compounding from approved (fi ni shed) drugs for an imals. The
regulations state that the regulations "shall not be construed as permitting compounding from
bulk drugs." FDA further issued a Compl iance Policy Guide (CPG) in July 1996 to discuss
FDA's po licy on compounding from bulk drugs for animals. The CPG essentially states that in
the absence of an approved Ilew animal drug app lication (NADA), the compounding of a new
an imal drug from a bulk drug resu lts in an adu lterated new an imal drug in violation ofFDCA
Section 50 1 (a)(5). However, in this CPG, FDA also identified compounding from bulk drugs for
non food animals as activity that "would not ordinarily be considered for regulatory action,"
consistent with past FDA enforcement discretion in this area.
2001
On November 2,2001, Stephen Sundlof, Director of the Center for Veterinary Medicine (CVM)
at FDA, announced to the Pharmaceutical Committee of the U.S. Animal Health Association that
CVM was initiating a "crackdown" on illegal drug compounding. In this presentation,
compounding from bulk in gredients was targeted as an illegal practice. The presentation
explained FDA's strategy to "dry up the source of su pply" of bulk drugs used to compound drugs
I The U.S. Court of Appeals is the highest federal court before the Supreme Court. At least one of these cases was
appealed to the Supreme Comt, which refused to hear the case.
2
IACP002717
for an imals by curta iling imports of bulk drugs and taking enforcement action against suppliers
of bu lk drugs to pharmacies.
Until 2001, there were very few enforcement actions by FDA regarding compounding fTom bulk
ingredients for animals-<lllly a couple of cases in the 1990's of FDA enforcement action against
pharmacies that were compounding for food animals. Because of the technical nature and legal
risks of such compounding, IACP, in general, adv ised against compounding for food animals.
However, FDA exercised lenient enforcement discretion on compounding from bulk ingredients
for non food animals and did not initiate enforcement action against pharmacies engaging in th is
practice.
2002
In April 2002, the U.S. Supreme Court overturned Section S03A of the Food and Drug
Administration Modernization Act of 1997 (FDAMA) due to unconstitutional advertising
restrictions. Section S03A had been added as a pa11 of FDAMA to address growing concerns
about FDA's regulati on of compounding. Section S03A included a recognition that
compounding was legal and outlined specific parameters whereby compounding would be
exempt from FDA's New Drug Applications (NDA) and Good Manufacturing Practices (GMP).
It also provided for the use of bulk ingredients in compounding. FDAMA Section S03A is
considered applicable to medications compounded for human patients.
In May 2002, FDA's Center for Drug Evaluation and Research (COER) published a revised CPG
on Pharmacy Compounding that outlined factors that the agency would use to distinguish
between pharmacy compounding and manufacturing in the guise of compounding. IACP had a
number of concerns with this guidance, which we have been actively working with CDER to
resolve. CDER has announced that it will issue a revised, draft CPG for public comment during
summer 2004.
2003
In July 2003, FDA's Center for Veterinary Medicine (CVM) issued a revised CPG on an imal
drug compounding. In this CPG, FDA reversed its policy of allowing compounding from bulk
ingredients for non food animals. FDA abruptly reversed this policy without providing any
justification for the change and without a llowing input from affected part ies. FDA issued this
CPG as a fin al guidance, in violation of FDA' s good guidance practices regulation. This is a
significant policy change whi ch has many severe and adverse implications for animal health and
the viabi lity of many small businesses.
WHY IS FDA CONCERNED ABOUT ANIMALS?
FDA's concern with compounding for anima ls appears to stem from complaints from
pharmaceutical manufacturers over the copying of commercially available products. There seem
to be more intense complaints from pharmaceutical manufacturers over the copying of
commercially avai lable animal prod ucts than human products. FDA states that they do not want
to concede that some compounding from bulk phannaceutical ingredients is acceptable because
it weakens their case against the types of compounding they want to limit (i.e. large-scale
copying of commercial product).
However, there are alternative, less burdensome means to limit such large-scale copying of
commercial product without promulgating a CPG that eliminates all compounding from bu lk
3
IACP002718
(
ingredients, and likewise eradicates many beneficial therapies for non food animal s. IACP has
written extens ive conunents outlining suggested revisions to the CPG and has presented FDA
with these proposals on several occasions, as detailed below.
Compounding Pharmacy has had extensive past conversations with FDA's Center for Drug
Evaluation and Research (COER), the Center responsible for human drugs; yet FDA's Center for
Veterinary Medicine (CVM), the Center responsible for animal drugs, has not beneli ted from
such history. Therefore, CVM was largely ignorant of the an im al patient needs involved in this
issue or our willingness to resist their blanket ban on all compounding from bulk pharmaceutical
ingred ients. We have been presented with no evidence to suggest that pharmacy compounding
has an adverse impact on non food animal health . On the contrary, there is extensive evidence
demonstrating that animals have often benefited from these services.
lACP's EFFORTS TO MODIFY VET CPG
IACP has asked FDA to withdraw the CPG and reissue it in draft form to allow affected parties
to comment, but FDA has not responded to this request.
Meeting with FDA CVM
IACP began negotiations with FDA during a face-to-face meeting in September 2003. During
th is meeting, IACP outlined a number of concerns with the rev ised CPG, including the new
prohibition on compounding from bu lk ingredients for non food an imals and the procedu ral
vio lations in issuance of the CPG. lACP submitted extensive written comments to FDA
outlining our concerns. FDA CVM did not indicate willingness to withdraw or even revise the
problematic CPG. FDA CVM instead ind icated that they were unaware of any problems or
compl~ ints regarding the newly revi sed ePG.
Veterinarians, Pharmacists and Animal Owners Speak Up
FDA's declared lack of knowledge of the CPG's adverse impacts prompted IACP to launch a
thorough, multi-pronged, grassroots effOit to educate FDA on the scope of th is prob lem. Over
the past nine months, FDA has received thousands of letters fi'om concerned pharmacists,
veterinarian s, and pet owners. Most ask FDA to withdraw the CPG and to rei ssue it in draft form
to allow for affected parties to comment. Many Senators and Representatives have additionally
received letters from their constituents and have subsequently contacted FDA to ask that the
CrG be rev ised or withdrawn.
Discussions with FDA CVM Ombudsman
Receiving again no response from FDA, IACP initiated conversations with Marcia Larkin, FDA
CVM Ombudsman. Thc Ombudsman's office probed CVM on their reasoning behind po licy
statements and on their method of issuing the CPG, and shared some of FDA's reasoning with
IACP (see "FDA's Claims and lACP's Rebunal"). The Ombudsman ind icated that the lack of
distinct ion between food and non food an imals and other restrictive changes in this CPG
stemmcd from FDA's " increased concerns about compounding activity." The Ombudsman was
unable to give any details or relay the specific nature of these concerns.
In early March 2004, IACP submitted a Freedom of Information Act (FOIA) request to FDA
CYM asking for copies of any documents or written materials detailing the complaints on
compounded medications that led CVM to have concerns with compounding for non food
animals. This request should return information on any adverse events or case evidence FDA is
4
IACP002719
using to justify its drastic shift in policy regarding compounding for non food animals. We have
received no response.
Small Business Administration
In add it ion, IACP has engaged in a number of discussions with the Small Business
Administration. IACP has consulted with SBA's Office of Advocacy and SBA's Ombudsman
regarding tools and strategies that may assist in our efforts to have the CPG withdrawn. IACP
assisted several members in filing complaints with the SBA under the Small Business Regulatory
Enforcement Fairness Act (SBREFA). SBA presented these complaints to FDA. FDA must
subsequently respond to a series of SBA questions. We have not yet rece iv ed FDA's response.
FDA RESPONSE TO CONCILlA TION EFFORTS
In spite oflACP's numerous efforts, FDA continues to be unresponsive to req uests for
withdrawal and revision of its animal drug compounding CPG. In addition to being
unresponsive, FDA has shown increasingly increasing inflex.ibility in recent communications.
FDA Letter to Compounding Stakeholder
A compounding stakeholder recently sent a letter to FDA CVM requesti ng withdrawal and
revision of the animal drug compounding CPG, specifically requesting that the guidance be
revised to permit the use of bulk active ingredients in compounding of drugs for compani on and
exotic animals. In his response, FDA CVM Director, Stephen Sundlof, states that CVM "do[es]
not agree that the guidance should be withdrawn or modified." FDA apparently has no intention
to revise the guidance, in spite of statements in the Federal Register notice and other
communications that the Agency "requests comments on the guidance and will revise the
document, if appropriate."
FDA Letter to Pharmacy
In add ition, FDA recently sent a letter to an IACP member pharmacy that contains a number of
concerning statements about veterin ary compounding. Specifically, the rhetoric in the letter
clearly demonstrates that FDA enforcement actions are not being confined to phannacies whose
practices emulate those of a drug manufacturer. FDA's purported concern and reasoning for
issuing the ePG was to address veterinarians and pharmacists engaged in activities analogous to
manufacturing. However, in terms of s ize and scope of practice, this pharmacy is representative
of most community compounding pharmacies. Certainly the pharmacy does not fit the
description of entities targeted for enforcement acti on. Further, the pharmacy assures FDA in the
letter that it wi ll not compound commercially ava ilable products, office stock products for
veterinarians, from products withdrawn from the market for safety reasons, or use bulk
ingredients to compound medications for food animals. The pharnlacy also indicates that it wil l
only compound products for non food animals upon receipt of a prescription generated in a valid
veterinary-client-patient relationship. However, FDA states that these assurances "are not
sufficient to bring your firm and compounded products into compliance with the Act." Under
the prior animal drug compounding CPG (1996), these assurances would have been sufficient to
classify the compounding as activity that "would not ord inarily be considered fo r regul atory
action." Clearly, FDA is enforcing provisions of the new CPG against local phannacies in ways
that will be detrimental to animal health.
Further, FDA asserts in this letter that horses are considered by the Agency to be food an imals.
fDA writes that it "receives USDA rep0l1s of violat ive drug residues in the edible tissues of
5
IACP002720
(
•
, (
horses offered for slaughter for human food for foreign markets." This is an unreasonable
assertion. First, horses are not designated as a food animal in the United States. Pharmacists
compound medicat ions for many equine performance and companion animals. Equine
organizations have estimated that 15% of equine medications must be compounded. To deny
treatment of these animals based on a claim that horses are a "food animal" is unreasonable and
would result in unnecessary suffering and harm to this animal population. Further, withdrawal
times are not required or provided on many FDA-approved, manufactured medications indicated
only for use in horses. Instead, many of the drug products contain the following, approved
language in the package inselt, "Note: Not for use in horses intended for food ." It is absolutely
unreasonable for FDA to require withdrawal times for medications compounded in a pharmacy,
whi le not requiring this same information on manufactured products. Pharmacists must be
allowed to compound products for horses with inclusion of the statement, "Note: Not for use in
horses intended for food."
FDA Communications with State Boards of Pharmacy
We are funher aware that FDA has engaged in informal conversations with several State Boards
of Pharmacy, encouraging state agencies to add restrictions to phamlacy laws and regulations
appli cable to veterinary compounding. Citing pressure fi-om FDA, the Arkansas State Board of
Pharmacy added such a stipulation to its pharmacy compounding ru les in November 2003. The
Texas State Board of Pharmacy also cited a pharmacy for compounding for non food animals, an
unprecedented enforcement action at the state level.
Then, on April 2, 2004, FDA sent a formal letter to all State Boards of Phamlacy indicating that
they will initiate an inspection campaign based on (he animal drug compounding CPG. CYM
requests the cooperation of the State Boards of Pharmacy in these inspections, stating:
In an effort to determine [he extent of illegal veterinary compounding activities, CVM is
issuing inspection assignments to FDAjieid offices to inspect certain pharmacies .
... Only twenty pharmacies were selected at this time due to limited resources.
The purpose of this letler is to request your Board's assistance and participation in these
inspections . ... While these initial inspections may not include a pharmacy ji-om your
SIGte, we still wanted to inform you of FDA's position on compounded veterinOlY drugs
and to request your participation il1jilture assignments.
IACP, in conjunction with the American Phannacists Association (APhA) and the National
Community Phannacists Associalion (NCPA), wrote an immediate response asking FDA to
retract the letter and expressing our disagreement with FDA's actions.
This announcement showcases FDA's persistence and inflexibility on this issue. On numerous
occasions FDA has been unresponsive to the pharmacy community's requests for reasonable
revisions to the CPG. Rather than negotiating with affected parties to achieve productive
solutions to this impasse, FDA has chosen to openly enforce a flawed policy. These pending
enforcement actions will force phannacies to discontinue all compounding for animals, which
will cause unnecessary suffe ring and harm to many animals.
FDA CLAIMS & REBUTTAL
FDA Had an "Urgent Need" to Issue the CPG in Final Form
6
IACP002721
Myth: "This compliance policy guidance is being issued as a Levell guidance consistent with
FDA's good guidance practices (GGPs) regulation. [t is being implemented immediately without
prior public comment, because ofthe agency's urgent need to explain how, in light of the recent
court decision and revised policy regarding drugs for human use, it intends to exercise its
enforcement discretion regarding compounded drugs for animal use. However, under GGPs,
FDA requests comments on the guidance and will revise the document, ifappropriate." 68 Fed
Reg. 41,591 (Ju ly 14,2003).
IACP Response: FDA CYM argues that it implemented this ePG without prior public comment
due to an "urgent need to explain how, in light of the recent court decision and revised policy
regarding drugs for human use, it intends to exercise its enforcement discretion regarding
compounded drugs for animal use." However, FDA responded to the Western States case a full
15 months after the decision was issued. Further, the Western States case was inapplicable to
eYM policy, as FOAM A Section 503A applied on ly to human compounding. FDA CDER used
identical reasoning (i.e. "urgent need ... ") when it implemented a pharmacy compounding ePG
only one month after the Western States decision. COER's reasoning for immediate issuance
was much more compelling; yet eDER has publicly agreed to revise its CPG and issue a new
guidance in draft form . Although CYM has received thousands of comments on the ePG and
the above announcement indicates that it will "revise the document, if appropriate," CYM has
shown no willingness to revise the guidance. Further, IACP bas evidence that eYM solicited
comments from one, select industry group prior to its release. This evidence certainly indicates
that there was no "urgent need" and that FDA had time but chose not to solicit broad input from
all affected parties prior to finalization of the guidance document.
FDA Citing Increased Concern in Policy Reversal/or Non Food Animals
FDA: On a number of occasions, FDA has cited an "increased concern" over medications
compounded for non food animals, especially those compounding from bulk ingredients. FDA
has cited this concern in reference to the Agency's decision to alter its policy on exercising its
regulatory di scretion concerning compounding for non food animals.
IACP Response: [Aep has repeatedly requested documentation of any concerns. IACP
submitted a FOtA request asking for copies of any documents or written materials detail ing the
complaints on compounded medications that led CYM to have concerns with compounding for
non food animals. In addition, [ACP has coordinated with a number ofSenalOrs and
Representatives to ask. similar questions of FDA. FDA has not responded to our FO[A request
and has been elusive when answering questions of this nature posed by members of Congress.
Compounded Medications Are Subjeclto New Animal Drug Application (NADA) Requirements
FDA: FDA has asserted on a number of occasions that "any animal drugs compounded from
bulk drug substances are subject to the same approval requirements as any other animal drugs."
FDA stales tbat in the absence of an approved New Anima[ Drug App[ication (NADA) the
compounding of an an imal medication from a bulk drug results in an unsafe and adulterated new
animal drug in violation ofFDCA Section 50[(a)(5).
IACP Response: [ACP strongly disagrees with FDA's interpretation that compounded
medications are subject to the FDCA new drug approval requirements and has an entire legal
brief devoted to this subject. Compounded medications are not subject to the FDCA new drug
approval process and never have been. Medication compounding by pharmacists does not
constitute the manufacturing of "new drugs." Historically, while the FDA has subjected "new
7
lACP00272~
(
t ,
drugs" to its stringent statutory requirements, pharmacists have continued the traditional
compounding of drugs without interference from the FDA.
The FDCA and the processes it mandates were designed to address situations where a "new
drug" would be developed over time, proved as to its safety and efficacy and then mass marketed
to millions of people throughout the United States. There is an obvious conflict between the
concept ofa "new drug" and a compounded medication. A compounded medication is
customized to meet a unique patient need, such as an allergy to a dye or ingredi ent, that cannot
be met by a mass manufactured drug. Such medications are compounded upon receipt of a
physician's prescription and are used fairly promptly after they are formu lated. Because of the
limited and specific nature of compounded formulations, it would simply be imposs ible to
subject each unique compounded medication to the rigorous "new drug" approval process that
requires the investment of substantial capital and takes years to accomplish. To have applied the
"new drug" requirements of FDCA to the process of compounding from 1938 forward would
have been tantamount to outlawing compounding, and this, clearly, was neidler intended nor
occurred . It is inconceivable that Congress intended to deem all compounding to be illegal
under the FDCA, and it is even more unlikely that Congress would have taken this drastic step
without explicitly saying so.
Note: While IACP disagrees that compounding is subject to FDA req uirements pe rtinent to new
drugs, we are currently asking FDA to, at minimum, di stinguish between compounding for food
and non food animals in its CPO due to FDA's persistent stance on compounding from bulk
drugs for animals.
IMPACT ON ANIMAL OWNERS AND THEIR PETS
If FDA's current animal drug compounding CPO is not revised and continues to be enforced,
many pets will lose access to vital medications. IACP has received copies of over 1,500 letters
from pet owners concel11ed about the impact of the CPO on their ab ility to obtain necessary
compounded medications for their pets.
Pet owners write:
Our poodle, Prince, receives potassium bromide for severe brain seizures and would die
withollt it. He has severe brain seizures that are uncontrollable lVithoutthis medication.
There is no other medication he can take or that helps him. To see him have a seizllre is
enough to tear your hearl guts out. He s'!ffers so severely from this condition. As I stated
before, he would die lVithoUi this medication!
Brenda from Florida
My pet Pee Jei, a sharp-pei receives colchicine medicationjrom a compounding
pharmacy to treat kidney disease. Without this medication, kidneys will fail resulting in
death of our belovedfriend and family member. We've already lost three animals to
kidney disease. It's like losing a child, a bestjriend, and afamily member all in one.
J. W. from Arizona
Daisy, my cocker spaniel, receives hydrocortisone to treat her condition. Without this, my
dog will nol have her health and wilh an Rx thai isn't compounded she will have side
~ffects which she doesn '/ have now. She has suffered 10 years with ear pressure and a
compromising im",une system. After 10 years, we finally found a prescription that is
8
IACP002723
helping. Please, please do not take her health away. She's so sweet, is our baby and
we've tried so hardfor so many years to keep her health. Please!
Linda from Maryland
My pet, Desi, a 12 year old cat, receives medication from a compounding pharmacy to
treat ongoing bacteria in his bladder and stave off infection. A1y pharmacist must use
bulk chemicals to make this medication for l11y pet. Without it, Desi would continue to
have blood and bacteria in his urine and suffers bladder infections. We have struggled
with this condition since June of this year and this antibacterial medication is the ol1ly
thing that has worked! He is just about back to his normal, happy selfsince we got his
conditiol1 under control through this medication.
Barbara from Michigan
Cheshire Hull, my jerret, receives prednisolone for insulinoma and adrenal disease. She
would die a slow ugly death without th is medication. II is imperative that she receive this
treatment. Please don't take it away from her.
Michel le from Florida
As these testimonials demonstrate, lack of access to compounded medications would cause the
unnecessary suffering, harn1, and even death of many companion, exotic, and performance
an im als. Pet owners would suffer significant emotional distress in th is process and often a loss
of companionship. Exotic animal owners, especially zoos, would also suffer the loss of a
tremendous capital investment. All of the suffering, loss, and death is completely unnecessary
and could be easily al leviated by allowing phannacists the continued ability to compound
medications for these animals from necessary bulk ingredients.
IMPACT ON VETERlNARIANS
From communications with practicing veterinarians, it is ev ident that veterinarians are extremely
concerned with FDA's animal compounding CPG. Veterinarians are acutely aware of the impact
of the CPG on their ability to properly treat the medical conditions of their patients. There are
many animal patients that cannot tolerate commercial medications, due to dosing, route of
administration, or comp liance issues. Compounding phalmacists offer a viab le solu tion to these
prob lems by customizing medications to meet the indi vidual patient's need. However, many
compounded medications for non food animals require the use of bulk ingredients. Veterin arians
recognize that bulk ingredients are fundamental to pharmacists' ability to meet their patients '
medication needs. Likewise, IACP has received over 500 copies of letters sent from practicing
veterinarians to FDA asking for withdrawal and revision ofthe CPG. Clearl y, the serv ices of
compounding pharmacists are essential to a veterinarian 's abi lity to properly treat his or her
patients.
FUlther, it is our experience that state-level veterinary associations are often very supportive of
their membership re lative to recognizing the adverse impacts of the animal drug compounding
CPG on practicing veterinarians and supporting efforts to ensure that the CPG is withdrawn and
revised. lAC!' has worked to further engage state-level veterinary medical associations by
mailing a packet of infOlmation on the animal drug compounding CPG to each state veterinary
association. IACP is soliciting the support of these associations, asking each vet association to
write a letter to FDA and to engage their members in a grassroots, letter writing campaign.
9
IACP002724
(
IACP has also engaged in a number of discussions with the American Veterinary Medical
Association (AMVA) to explore collaboration on changing elements of the animal drug
compounding CPG. While AVMA has indicated that it wi ll not ask for rescission of the CPG,
A VMA has also acknowledged that there are a number of problematic elements of the current
CPG that should be revised . Although A VMA and IACP differ on the poli tical strategy that
should be used to change the CPG, both organizations have agrced that bulk drugs are nccessary
for compounding many medications for non food animals. The organizations plan to publish a
consensus statement in the near future that wi ll elaborate our agreement.
IMPACT ON PHARMACISTS
FDA's animal compounding CPG will not only preclude pharmacists from meeting the
medication needs of many companion, exotic, and performance animals, it will also have a
tremendous adverse affect on the business practices of many pharmacies. IACP's membersh ip
inc ludes many pharmacics th at provide compounding services only (i.e. they do not have a
trad it iona l, retai l component of their pharmacy practice). Pharmacies may choose this business
model to allow them to focus all their attention on providing high quality compounded
med ications to their patients. Fut1her, compounding for non food animals is a significant part of
most compounding pharmacy practices. In fact, there are several compound ing pharmacies that
special ize in prov iding only veterin ary compounding services. The veterinary CPG, as written,
will completely eliminate many compounding phannacy practices and will have a severe impact
on remaining businesses.
FDA's recent actions ind icate th at pharmacy owners must make a choice between losing their
business or cont inuing to compound necessary medications for non food an imals and ri sking
FDA enforcement action. FDA has initiated this enforcement activity without having provided
any analysis of the animal health or business impacts of its policy. Clearly, th is activity is
having a tremendous adverse impact on pharmacies and is not a workable situation.
The pharmacy community continues to reach out to FDA CVM, in spite of their continuing
di sregard of our overtures, and is making continued efforts toward resolution of concerns with
this policy.
STRATEGY OUTLOOK
Due to FDA's hard line stance on this issue and the announcement of an enforcement campaign,
this issue has become increasingly urgent in the pharmacy and veterinary commun ities. IACP
will, likewise, increase th e urgency ofthis issue to ensure that this CPG is withdrawn and
revised.
10
IACP002725
Quoted from Source Found here--http://democrats.energycommerce.house.gov/sites/default/files/documents/Issue-Briefing-Compounding-for-Animals.pdf
ISSUE BRIEFlNG
EXECUTIVE SUMMARY
Since its inception in 1930, FDA has allowed pharmacists to compound medications from bulk
active pharmaceutical in gredients (APIs) for non food an imal s, including companion, exotic, and
perfonnance animals.
However, in July 2003, FDA abruptly reversed this policy without any indication of the
reasoning or justification behind the substantial policy reversal. FDA's new prohibition on
compounding for non food animals will adversely affect the health and well-being of many pets
and will have broad repercussions on many small businesses.
IACP has repeatedly attempted to negotiate with FDA on these polici es. However, the Agency
remains unmoved. FDA sent infonnation to State Boards of Pharmacy in April 2004 announcing
the initiation of an inspection campaign against pharmacies that compound for animals.
Developments of this nature make this issue increasingly urgent for pharmacists and
veterinar ians who provide care for an imal patients.
NECESSITY OF VETERINARY COMPOUNDING
IACP strongly supports the rights of pharmacists to compound for non food animals from bulk
ingredients. Such compounding is part of the fundamental, historical practice ofphannacy and
necessary to preserve the health and well-being of many companion, exotic, and performance
animals. Ifphannacists are limited to using FDA-approved, commercially available drugs, many
animals will die, go untreated, or su ffer needlessly.
There are many situations that may require pharmacists to compound medications from bulk
ingredients for animal patients, which may include:
I) Discontinued Products: Pharnlacists can compound commercial medications that have been
discontinued from the market, no! for reasons of safety or effectiveness, and that would
otherwise be unavailable;
2) Product Integrity: Pharnlacists use bulk APls to compound medications when using a
commercially available, fin ished product as the ingredient source could add unnecessary
excipients to the medication and increase the risk of contamination (e.g. sterile medications)
or yield a product which is not concentrated enough to offer proper compliance;
3) No Alternative Therapy: Pharmacists often compound medications using bulk APls when
there is no commercial alternative to treat the disease state or condition treated by the
compounded medication;
4) Patient Compliance: Pharmacists also compound some medications for animal patients to
make it eas ier for pet owners to administer medication to their pet, which often in vo lves
flavoring a medication or chan ging the dosage form.
FDA itself has repeatedly recognized the importance of compounding medications for an imals,
inasmuch as commercially available drugs significantly underserve animal patients.
Pharmacists, who can customize medications based on a veterinarian's prescription to meet an
animal's unique medication need, currently address this gap in medication access ibility.
IACP002716
However, pharmacists must have access to bulk APIs to continue meeting these needs and to
prevent the unnecessary suffering and harm of animals.
REGULATORY TIMELINE
1988 and 1989
The U.S. Food and Drug Administration (FDA) has long contended that compounding for
anima ls from bulk ingred ients is illegal. This position is supported by two U.S. Court of
Appeals' decisions: Uni ted States v. Algon Chemical Inc., 879 F.2d 1 154 (3d Cir. 1989) and
Uni ted States v. 9/1 Kg. Containers, 854 F.2d 173 (7th Cir. 1988). FDA argues that these cou,t
cases affirm its position that the Federal Food Drug & Cosmetic Act of 1938 (FDCA) does not
permit veterinarians to compound unapproved finished drug products from bulk ingredients,
un less the fi nished drug is not a new animal drug. FDA extends the principle established by the
court to compounding by pharmacists.
One of the COUIts specifically acknowledged the FDA's pol icy that, if the need is great and the
risk small, the FDA may exercise regulatory di scretion with respect to veterinarians
compounding from approved drugs. For many years, FDA has exercised regulatory discretion in
allowing compounding of medications from bulk ingredients for non food animals.
These two court cases are significant in that FDA cites them to support their theory that
compounding from bu lk drugs for animals is subject to FDA's enforcement discretion.
1994
Congress passed the Animal Medicinal Drug Use Clarification Act (AMDUCA) in October 1994
to allow and set parameters for extra label uses of approved animal drugs and approved human
drugs in an imals. The AMDUCA law does not contain any specific references to compounding.
1996
FDA issued fina l regulat ions implementing AMDUCA November 1996. Section 530. 13 of these
regulations sets parameters for compounding from approved (fi ni shed) drugs for an imals. The
regulations state that the regulations "shall not be construed as permitting compounding from
bulk drugs." FDA further issued a Compl iance Policy Guide (CPG) in July 1996 to discuss
FDA's po licy on compounding from bulk drugs for animals. The CPG essentially states that in
the absence of an approved Ilew animal drug app lication (NADA), the compounding of a new
an imal drug from a bulk drug resu lts in an adu lterated new an imal drug in violation ofFDCA
Section 50 1 (a)(5). However, in this CPG, FDA also identified compounding from bulk drugs for
non food animals as activity that "would not ordinarily be considered for regulatory action,"
consistent with past FDA enforcement discretion in this area.
2001
On November 2,2001, Stephen Sundlof, Director of the Center for Veterinary Medicine (CVM)
at FDA, announced to the Pharmaceutical Committee of the U.S. Animal Health Association that
CVM was initiating a "crackdown" on illegal drug compounding. In this presentation,
compounding from bulk in gredients was targeted as an illegal practice. The presentation
explained FDA's strategy to "dry up the source of su pply" of bulk drugs used to compound drugs
I The U.S. Court of Appeals is the highest federal court before the Supreme Court. At least one of these cases was
appealed to the Supreme Comt, which refused to hear the case.
2
IACP002717
for an imals by curta iling imports of bulk drugs and taking enforcement action against suppliers
of bu lk drugs to pharmacies.
Until 2001, there were very few enforcement actions by FDA regarding compounding fTom bulk
ingredients for animals-<lllly a couple of cases in the 1990's of FDA enforcement action against
pharmacies that were compounding for food animals. Because of the technical nature and legal
risks of such compounding, IACP, in general, adv ised against compounding for food animals.
However, FDA exercised lenient enforcement discretion on compounding from bulk ingredients
for non food animals and did not initiate enforcement action against pharmacies engaging in th is
practice.
2002
In April 2002, the U.S. Supreme Court overturned Section S03A of the Food and Drug
Administration Modernization Act of 1997 (FDAMA) due to unconstitutional advertising
restrictions. Section S03A had been added as a pa11 of FDAMA to address growing concerns
about FDA's regulati on of compounding. Section S03A included a recognition that
compounding was legal and outlined specific parameters whereby compounding would be
exempt from FDA's New Drug Applications (NDA) and Good Manufacturing Practices (GMP).
It also provided for the use of bulk ingredients in compounding. FDAMA Section S03A is
considered applicable to medications compounded for human patients.
In May 2002, FDA's Center for Drug Evaluation and Research (COER) published a revised CPG
on Pharmacy Compounding that outlined factors that the agency would use to distinguish
between pharmacy compounding and manufacturing in the guise of compounding. IACP had a
number of concerns with this guidance, which we have been actively working with CDER to
resolve. CDER has announced that it will issue a revised, draft CPG for public comment during
summer 2004.
2003
In July 2003, FDA's Center for Veterinary Medicine (CVM) issued a revised CPG on an imal
drug compounding. In this CPG, FDA reversed its policy of allowing compounding from bulk
ingredients for non food animals. FDA abruptly reversed this policy without providing any
justification for the change and without a llowing input from affected part ies. FDA issued this
CPG as a fin al guidance, in violation of FDA' s good guidance practices regulation. This is a
significant policy change whi ch has many severe and adverse implications for animal health and
the viabi lity of many small businesses.
WHY IS FDA CONCERNED ABOUT ANIMALS?
FDA's concern with compounding for anima ls appears to stem from complaints from
pharmaceutical manufacturers over the copying of commercially available products. There seem
to be more intense complaints from pharmaceutical manufacturers over the copying of
commercially avai lable animal prod ucts than human products. FDA states that they do not want
to concede that some compounding from bulk phannaceutical ingredients is acceptable because
it weakens their case against the types of compounding they want to limit (i.e. large-scale
copying of commercial product).
However, there are alternative, less burdensome means to limit such large-scale copying of
commercial product without promulgating a CPG that eliminates all compounding from bu lk
3
IACP002718
(
ingredients, and likewise eradicates many beneficial therapies for non food animal s. IACP has
written extens ive conunents outlining suggested revisions to the CPG and has presented FDA
with these proposals on several occasions, as detailed below.
Compounding Pharmacy has had extensive past conversations with FDA's Center for Drug
Evaluation and Research (COER), the Center responsible for human drugs; yet FDA's Center for
Veterinary Medicine (CVM), the Center responsible for animal drugs, has not beneli ted from
such history. Therefore, CVM was largely ignorant of the an im al patient needs involved in this
issue or our willingness to resist their blanket ban on all compounding from bulk pharmaceutical
ingred ients. We have been presented with no evidence to suggest that pharmacy compounding
has an adverse impact on non food animal health . On the contrary, there is extensive evidence
demonstrating that animals have often benefited from these services.
lACP's EFFORTS TO MODIFY VET CPG
IACP has asked FDA to withdraw the CPG and reissue it in draft form to allow affected parties
to comment, but FDA has not responded to this request.
Meeting with FDA CVM
IACP began negotiations with FDA during a face-to-face meeting in September 2003. During
th is meeting, IACP outlined a number of concerns with the rev ised CPG, including the new
prohibition on compounding from bu lk ingredients for non food an imals and the procedu ral
vio lations in issuance of the CPG. lACP submitted extensive written comments to FDA
outlining our concerns. FDA CVM did not indicate willingness to withdraw or even revise the
problematic CPG. FDA CVM instead ind icated that they were unaware of any problems or
compl~ ints regarding the newly revi sed ePG.
Veterinarians, Pharmacists and Animal Owners Speak Up
FDA's declared lack of knowledge of the CPG's adverse impacts prompted IACP to launch a
thorough, multi-pronged, grassroots effOit to educate FDA on the scope of th is prob lem. Over
the past nine months, FDA has received thousands of letters fi'om concerned pharmacists,
veterinarian s, and pet owners. Most ask FDA to withdraw the CPG and to rei ssue it in draft form
to allow for affected parties to comment. Many Senators and Representatives have additionally
received letters from their constituents and have subsequently contacted FDA to ask that the
CrG be rev ised or withdrawn.
Discussions with FDA CVM Ombudsman
Receiving again no response from FDA, IACP initiated conversations with Marcia Larkin, FDA
CVM Ombudsman. Thc Ombudsman's office probed CVM on their reasoning behind po licy
statements and on their method of issuing the CPG, and shared some of FDA's reasoning with
IACP (see "FDA's Claims and lACP's Rebunal"). The Ombudsman ind icated that the lack of
distinct ion between food and non food an imals and other restrictive changes in this CPG
stemmcd from FDA's " increased concerns about compounding activity." The Ombudsman was
unable to give any details or relay the specific nature of these concerns.
In early March 2004, IACP submitted a Freedom of Information Act (FOIA) request to FDA
CYM asking for copies of any documents or written materials detailing the complaints on
compounded medications that led CVM to have concerns with compounding for non food
animals. This request should return information on any adverse events or case evidence FDA is
4
IACP002719
using to justify its drastic shift in policy regarding compounding for non food animals. We have
received no response.
Small Business Administration
In add it ion, IACP has engaged in a number of discussions with the Small Business
Administration. IACP has consulted with SBA's Office of Advocacy and SBA's Ombudsman
regarding tools and strategies that may assist in our efforts to have the CPG withdrawn. IACP
assisted several members in filing complaints with the SBA under the Small Business Regulatory
Enforcement Fairness Act (SBREFA). SBA presented these complaints to FDA. FDA must
subsequently respond to a series of SBA questions. We have not yet rece iv ed FDA's response.
FDA RESPONSE TO CONCILlA TION EFFORTS
In spite oflACP's numerous efforts, FDA continues to be unresponsive to req uests for
withdrawal and revision of its animal drug compounding CPG. In addition to being
unresponsive, FDA has shown increasingly increasing inflex.ibility in recent communications.
FDA Letter to Compounding Stakeholder
A compounding stakeholder recently sent a letter to FDA CVM requesti ng withdrawal and
revision of the animal drug compounding CPG, specifically requesting that the guidance be
revised to permit the use of bulk active ingredients in compounding of drugs for compani on and
exotic animals. In his response, FDA CVM Director, Stephen Sundlof, states that CVM "do[es]
not agree that the guidance should be withdrawn or modified." FDA apparently has no intention
to revise the guidance, in spite of statements in the Federal Register notice and other
communications that the Agency "requests comments on the guidance and will revise the
document, if appropriate."
FDA Letter to Pharmacy
In add ition, FDA recently sent a letter to an IACP member pharmacy that contains a number of
concerning statements about veterin ary compounding. Specifically, the rhetoric in the letter
clearly demonstrates that FDA enforcement actions are not being confined to phannacies whose
practices emulate those of a drug manufacturer. FDA's purported concern and reasoning for
issuing the ePG was to address veterinarians and pharmacists engaged in activities analogous to
manufacturing. However, in terms of s ize and scope of practice, this pharmacy is representative
of most community compounding pharmacies. Certainly the pharmacy does not fit the
description of entities targeted for enforcement acti on. Further, the pharmacy assures FDA in the
letter that it wi ll not compound commercially ava ilable products, office stock products for
veterinarians, from products withdrawn from the market for safety reasons, or use bulk
ingredients to compound medications for food animals. The pharnlacy also indicates that it wil l
only compound products for non food animals upon receipt of a prescription generated in a valid
veterinary-client-patient relationship. However, FDA states that these assurances "are not
sufficient to bring your firm and compounded products into compliance with the Act." Under
the prior animal drug compounding CPG (1996), these assurances would have been sufficient to
classify the compounding as activity that "would not ord inarily be considered fo r regul atory
action." Clearly, FDA is enforcing provisions of the new CPG against local phannacies in ways
that will be detrimental to animal health.
Further, FDA asserts in this letter that horses are considered by the Agency to be food an imals.
fDA writes that it "receives USDA rep0l1s of violat ive drug residues in the edible tissues of
5
IACP002720
(
•
, (
horses offered for slaughter for human food for foreign markets." This is an unreasonable
assertion. First, horses are not designated as a food animal in the United States. Pharmacists
compound medicat ions for many equine performance and companion animals. Equine
organizations have estimated that 15% of equine medications must be compounded. To deny
treatment of these animals based on a claim that horses are a "food animal" is unreasonable and
would result in unnecessary suffering and harm to this animal population. Further, withdrawal
times are not required or provided on many FDA-approved, manufactured medications indicated
only for use in horses. Instead, many of the drug products contain the following, approved
language in the package inselt, "Note: Not for use in horses intended for food ." It is absolutely
unreasonable for FDA to require withdrawal times for medications compounded in a pharmacy,
whi le not requiring this same information on manufactured products. Pharmacists must be
allowed to compound products for horses with inclusion of the statement, "Note: Not for use in
horses intended for food."
FDA Communications with State Boards of Pharmacy
We are funher aware that FDA has engaged in informal conversations with several State Boards
of Pharmacy, encouraging state agencies to add restrictions to phamlacy laws and regulations
appli cable to veterinary compounding. Citing pressure fi-om FDA, the Arkansas State Board of
Pharmacy added such a stipulation to its pharmacy compounding ru les in November 2003. The
Texas State Board of Pharmacy also cited a pharmacy for compounding for non food animals, an
unprecedented enforcement action at the state level.
Then, on April 2, 2004, FDA sent a formal letter to all State Boards of Phamlacy indicating that
they will initiate an inspection campaign based on (he animal drug compounding CPG. CYM
requests the cooperation of the State Boards of Pharmacy in these inspections, stating:
In an effort to determine [he extent of illegal veterinary compounding activities, CVM is
issuing inspection assignments to FDAjieid offices to inspect certain pharmacies .
... Only twenty pharmacies were selected at this time due to limited resources.
The purpose of this letler is to request your Board's assistance and participation in these
inspections . ... While these initial inspections may not include a pharmacy ji-om your
SIGte, we still wanted to inform you of FDA's position on compounded veterinOlY drugs
and to request your participation il1jilture assignments.
IACP, in conjunction with the American Phannacists Association (APhA) and the National
Community Phannacists Associalion (NCPA), wrote an immediate response asking FDA to
retract the letter and expressing our disagreement with FDA's actions.
This announcement showcases FDA's persistence and inflexibility on this issue. On numerous
occasions FDA has been unresponsive to the pharmacy community's requests for reasonable
revisions to the CPG. Rather than negotiating with affected parties to achieve productive
solutions to this impasse, FDA has chosen to openly enforce a flawed policy. These pending
enforcement actions will force phannacies to discontinue all compounding for animals, which
will cause unnecessary suffe ring and harm to many animals.
FDA CLAIMS & REBUTTAL
FDA Had an "Urgent Need" to Issue the CPG in Final Form
6
IACP002721
Myth: "This compliance policy guidance is being issued as a Levell guidance consistent with
FDA's good guidance practices (GGPs) regulation. [t is being implemented immediately without
prior public comment, because ofthe agency's urgent need to explain how, in light of the recent
court decision and revised policy regarding drugs for human use, it intends to exercise its
enforcement discretion regarding compounded drugs for animal use. However, under GGPs,
FDA requests comments on the guidance and will revise the document, ifappropriate." 68 Fed
Reg. 41,591 (Ju ly 14,2003).
IACP Response: FDA CYM argues that it implemented this ePG without prior public comment
due to an "urgent need to explain how, in light of the recent court decision and revised policy
regarding drugs for human use, it intends to exercise its enforcement discretion regarding
compounded drugs for animal use." However, FDA responded to the Western States case a full
15 months after the decision was issued. Further, the Western States case was inapplicable to
eYM policy, as FOAM A Section 503A applied on ly to human compounding. FDA CDER used
identical reasoning (i.e. "urgent need ... ") when it implemented a pharmacy compounding ePG
only one month after the Western States decision. COER's reasoning for immediate issuance
was much more compelling; yet eDER has publicly agreed to revise its CPG and issue a new
guidance in draft form . Although CYM has received thousands of comments on the ePG and
the above announcement indicates that it will "revise the document, if appropriate," CYM has
shown no willingness to revise the guidance. Further, IACP bas evidence that eYM solicited
comments from one, select industry group prior to its release. This evidence certainly indicates
that there was no "urgent need" and that FDA had time but chose not to solicit broad input from
all affected parties prior to finalization of the guidance document.
FDA Citing Increased Concern in Policy Reversal/or Non Food Animals
FDA: On a number of occasions, FDA has cited an "increased concern" over medications
compounded for non food animals, especially those compounding from bulk ingredients. FDA
has cited this concern in reference to the Agency's decision to alter its policy on exercising its
regulatory di scretion concerning compounding for non food animals.
IACP Response: [Aep has repeatedly requested documentation of any concerns. IACP
submitted a FOtA request asking for copies of any documents or written materials detail ing the
complaints on compounded medications that led CYM to have concerns with compounding for
non food animals. In addition, [ACP has coordinated with a number ofSenalOrs and
Representatives to ask. similar questions of FDA. FDA has not responded to our FO[A request
and has been elusive when answering questions of this nature posed by members of Congress.
Compounded Medications Are Subjeclto New Animal Drug Application (NADA) Requirements
FDA: FDA has asserted on a number of occasions that "any animal drugs compounded from
bulk drug substances are subject to the same approval requirements as any other animal drugs."
FDA stales tbat in the absence of an approved New Anima[ Drug App[ication (NADA) the
compounding of an an imal medication from a bulk drug results in an unsafe and adulterated new
animal drug in violation ofFDCA Section 50[(a)(5).
IACP Response: [ACP strongly disagrees with FDA's interpretation that compounded
medications are subject to the FDCA new drug approval requirements and has an entire legal
brief devoted to this subject. Compounded medications are not subject to the FDCA new drug
approval process and never have been. Medication compounding by pharmacists does not
constitute the manufacturing of "new drugs." Historically, while the FDA has subjected "new
7
lACP00272~
(
t ,
drugs" to its stringent statutory requirements, pharmacists have continued the traditional
compounding of drugs without interference from the FDA.
The FDCA and the processes it mandates were designed to address situations where a "new
drug" would be developed over time, proved as to its safety and efficacy and then mass marketed
to millions of people throughout the United States. There is an obvious conflict between the
concept ofa "new drug" and a compounded medication. A compounded medication is
customized to meet a unique patient need, such as an allergy to a dye or ingredi ent, that cannot
be met by a mass manufactured drug. Such medications are compounded upon receipt of a
physician's prescription and are used fairly promptly after they are formu lated. Because of the
limited and specific nature of compounded formulations, it would simply be imposs ible to
subject each unique compounded medication to the rigorous "new drug" approval process that
requires the investment of substantial capital and takes years to accomplish. To have applied the
"new drug" requirements of FDCA to the process of compounding from 1938 forward would
have been tantamount to outlawing compounding, and this, clearly, was neidler intended nor
occurred . It is inconceivable that Congress intended to deem all compounding to be illegal
under the FDCA, and it is even more unlikely that Congress would have taken this drastic step
without explicitly saying so.
Note: While IACP disagrees that compounding is subject to FDA req uirements pe rtinent to new
drugs, we are currently asking FDA to, at minimum, di stinguish between compounding for food
and non food animals in its CPO due to FDA's persistent stance on compounding from bulk
drugs for animals.
IMPACT ON ANIMAL OWNERS AND THEIR PETS
If FDA's current animal drug compounding CPO is not revised and continues to be enforced,
many pets will lose access to vital medications. IACP has received copies of over 1,500 letters
from pet owners concel11ed about the impact of the CPO on their ab ility to obtain necessary
compounded medications for their pets.
Pet owners write:
Our poodle, Prince, receives potassium bromide for severe brain seizures and would die
withollt it. He has severe brain seizures that are uncontrollable lVithoutthis medication.
There is no other medication he can take or that helps him. To see him have a seizllre is
enough to tear your hearl guts out. He s'!ffers so severely from this condition. As I stated
before, he would die lVithoUi this medication!
Brenda from Florida
My pet Pee Jei, a sharp-pei receives colchicine medicationjrom a compounding
pharmacy to treat kidney disease. Without this medication, kidneys will fail resulting in
death of our belovedfriend and family member. We've already lost three animals to
kidney disease. It's like losing a child, a bestjriend, and afamily member all in one.
J. W. from Arizona
Daisy, my cocker spaniel, receives hydrocortisone to treat her condition. Without this, my
dog will nol have her health and wilh an Rx thai isn't compounded she will have side
~ffects which she doesn '/ have now. She has suffered 10 years with ear pressure and a
compromising im",une system. After 10 years, we finally found a prescription that is
8
IACP002723
helping. Please, please do not take her health away. She's so sweet, is our baby and
we've tried so hardfor so many years to keep her health. Please!
Linda from Maryland
My pet, Desi, a 12 year old cat, receives medication from a compounding pharmacy to
treat ongoing bacteria in his bladder and stave off infection. A1y pharmacist must use
bulk chemicals to make this medication for l11y pet. Without it, Desi would continue to
have blood and bacteria in his urine and suffers bladder infections. We have struggled
with this condition since June of this year and this antibacterial medication is the ol1ly
thing that has worked! He is just about back to his normal, happy selfsince we got his
conditiol1 under control through this medication.
Barbara from Michigan
Cheshire Hull, my jerret, receives prednisolone for insulinoma and adrenal disease. She
would die a slow ugly death without th is medication. II is imperative that she receive this
treatment. Please don't take it away from her.
Michel le from Florida
As these testimonials demonstrate, lack of access to compounded medications would cause the
unnecessary suffering, harn1, and even death of many companion, exotic, and performance
an im als. Pet owners would suffer significant emotional distress in th is process and often a loss
of companionship. Exotic animal owners, especially zoos, would also suffer the loss of a
tremendous capital investment. All of the suffering, loss, and death is completely unnecessary
and could be easily al leviated by allowing phannacists the continued ability to compound
medications for these animals from necessary bulk ingredients.
IMPACT ON VETERlNARIANS
From communications with practicing veterinarians, it is ev ident that veterinarians are extremely
concerned with FDA's animal compounding CPG. Veterinarians are acutely aware of the impact
of the CPG on their ability to properly treat the medical conditions of their patients. There are
many animal patients that cannot tolerate commercial medications, due to dosing, route of
administration, or comp liance issues. Compounding phalmacists offer a viab le solu tion to these
prob lems by customizing medications to meet the indi vidual patient's need. However, many
compounded medications for non food animals require the use of bulk ingredients. Veterin arians
recognize that bulk ingredients are fundamental to pharmacists' ability to meet their patients '
medication needs. Likewise, IACP has received over 500 copies of letters sent from practicing
veterinarians to FDA asking for withdrawal and revision ofthe CPG. Clearl y, the serv ices of
compounding pharmacists are essential to a veterinarian 's abi lity to properly treat his or her
patients.
FUlther, it is our experience that state-level veterinary associations are often very supportive of
their membership re lative to recognizing the adverse impacts of the animal drug compounding
CPG on practicing veterinarians and supporting efforts to ensure that the CPG is withdrawn and
revised. lAC!' has worked to further engage state-level veterinary medical associations by
mailing a packet of infOlmation on the animal drug compounding CPG to each state veterinary
association. IACP is soliciting the support of these associations, asking each vet association to
write a letter to FDA and to engage their members in a grassroots, letter writing campaign.
9
IACP002724
(
IACP has also engaged in a number of discussions with the American Veterinary Medical
Association (AMVA) to explore collaboration on changing elements of the animal drug
compounding CPG. While AVMA has indicated that it wi ll not ask for rescission of the CPG,
A VMA has also acknowledged that there are a number of problematic elements of the current
CPG that should be revised . Although A VMA and IACP differ on the poli tical strategy that
should be used to change the CPG, both organizations have agrced that bulk drugs are nccessary
for compounding many medications for non food animals. The organizations plan to publish a
consensus statement in the near future that wi ll elaborate our agreement.
IMPACT ON PHARMACISTS
FDA's animal compounding CPG will not only preclude pharmacists from meeting the
medication needs of many companion, exotic, and performance animals, it will also have a
tremendous adverse affect on the business practices of many pharmacies. IACP's membersh ip
inc ludes many pharmacics th at provide compounding services only (i.e. they do not have a
trad it iona l, retai l component of their pharmacy practice). Pharmacies may choose this business
model to allow them to focus all their attention on providing high quality compounded
med ications to their patients. Fut1her, compounding for non food animals is a significant part of
most compounding pharmacy practices. In fact, there are several compound ing pharmacies that
special ize in prov iding only veterin ary compounding services. The veterinary CPG, as written,
will completely eliminate many compounding phannacy practices and will have a severe impact
on remaining businesses.
FDA's recent actions ind icate th at pharmacy owners must make a choice between losing their
business or cont inuing to compound necessary medications for non food an imals and ri sking
FDA enforcement action. FDA has initiated this enforcement activity without having provided
any analysis of the animal health or business impacts of its policy. Clearly, th is activity is
having a tremendous adverse impact on pharmacies and is not a workable situation.
The pharmacy community continues to reach out to FDA CVM, in spite of their continuing
di sregard of our overtures, and is making continued efforts toward resolution of concerns with
this policy.
STRATEGY OUTLOOK
Due to FDA's hard line stance on this issue and the announcement of an enforcement campaign,
this issue has become increasingly urgent in the pharmacy and veterinary commun ities. IACP
will, likewise, increase th e urgency ofthis issue to ensure that this CPG is withdrawn and
revised.
10
IACP002725
Quoted from Source Found here--http://democrats.energycommerce.house.gov/sites/default/files/documents/Issue-Briefing-Compounding-for-Animals.pdf
No comments:
Post a Comment