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Monday, July 29, 2013
VETERINARY COMPOUNDING – FORMULATING THE FUTURE Dawn Merton Boothe, DM, PhD, DACVIM, DACVCP College of Veterinay Medicatine Auburn University, AL
Proceeding of 15th AAVPT Biennial Symposium – May 2007, Pacific Grove, CA
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VETERINARY COMPOUNDING – FORMULATING THE FUTURE
Dawn Merton Boothe, DVM, PhD, DACVIM, DACVCP
College of Veterinary Medicine
Auburn University, AL
Individualized drug therapy increasingly is important to the effective delivery of health
care to both the human and veterinary patient. Accordingly, compounding has enjoyed a
resurgence of importance to drug delivery. Contributing to the recent surge in compounding are
the loss of less lucrative approved drug products as pharmaceutical companies merge, emerging
special needs populations, pharmacogenomics and improvements in the standard of veterinary
care. Among the legitimate benefits provided by veterinary compounding are the
reformulation of drugs to facilitate dosing (e.g., flavored syrups, oral rather than injectable
preparations, transdermal gels) or to reduce the risk of adverse reactions due to over dosing. This
latter service has been a mainstay of veterinary compounding because of the extensive use of
human drugs in animals, reflecting, in turn, the limited number of animal approved drugs.
Compounding has been variably defined by different entities, but the pertinent
components of the definition include prescription driven and clinician-prescribed (or
formulated). Their importance was emphasized in 1997 by the US Supreme Court’s definition of
compounding as “a process by which a pharmacist or doctor combines, mixes, or alters
ingredients to create a medication tailored to the needs of an individual patient.” This definition
is equally applicable to veterinary and human compounding. However, in contrast to human
compounding, legal direction for veterinary compounding exists (the Animal Medicinal Drug
Use Clarification Act of 1994). Neither veterinarians nor pharmacists appear to be well
informed regarding the content or rationale for compounding rules promulgated by the FDA in
response to AMDUCA. Indeed, the pharmacy profession has objected to the Food and Drug
Administration’s perceived interpretation of AMDUCA, including the FDA’s restrictions to
compounding from bulk substances, which stem from a public health perspective. The
compounding profession has actively pursued legislation that will facilitate compounding
veterinary products. From the author’s perspective, these tactics have included a misleading
emotional appeal to the veterinary profession. “Protect the pharmacist’s right to compound”
was the opening page of the IACP website in 2004. It sought veterinary support of legislation
that would legalize compounding, including that from bulk substances, without FDA interference
(http://www.iacprx.org/site/PageServer?pagename=P2C2). Yet, the pharmacists’ right to
compound was not being challenged; indeed, AMDUCA guarantees that right for both
pharmacists and veterinarians. Rather, what was being “challenged” was the use of bulk
substances. Missing in the discussions are reasons that compounding from bulk substances might
be wisely avoided. These include the CVM’s concern regarding compounding in food animals;
this concern might be reduced but not necessarily avoided by a different set of rules for dogs,
cats or horses (for example, how might a legal definition of a food animal assure that any animal
consumed by humans in the USA would be included?). A second concern is assurance of the
quality of the bulk ingredient (see ingredient source below). A third concern is the ease with
which manufacturing may occur once compounding from bulk substances is approved. Indeed,
FDA concern regarding the distinction between compounding and manufacturing has led the
FDA to attempt to legally restrict manufacturing. The first attempt was based on restricted
advertisement (promotion) of compounding services in the Food and Drug Administration Proceeding of 15th AAVPT Biennial Symposium – May 2007, Pacific Grove, CA
Close the current window to return to the IVIS website or go to www.ivis.org
Reprinted in the IVIS website with the permission of the AAVPT – www.ivis.org
Modernization Act of 1996, which was ruled unconstitutional by a US District Court
(infringement of the right to freedom of speech). Subsequent restrictions by the FDA were based
on the regulatory responsibilities of the FDA, which has assumed that any compounded drug is a
new, yet unapproved drug. This distinction allows legal regulatory actions by the FDA.
However, in October of 2006, the Federal District Court of Texas ruled that compounded drugs
were not new drugs, precluding FDA regulatory oversight. Further, compounding from bulk
substances was ruled legal for non-food animals
(http://www.fdanews.com/dailies/drugdaily/2_425/news/59733-1.html). The IACP has declared
this a victory for consumers. In the author’s opinion, suggesting to the public that this ruling,
assured that FDA approval would be expected for each compounded product is a misleading
tactic if not accompanied by an explanation that compounded products undergo no pre-market
assessment, even when mass produced. From the author’s perspective, the intent of the FDA is
not to repress appropriate compounding but to protect the consumer from inappropriate
compounding. Indeed, would a fully informed public be as willing to accept and consume
compounded products?
Not surprisingly, selected compounding pharmacies have extended their compounding
activities well beyond that recognized to be appropriate by the FDA, thus circumventing the
approval process. Internet pharmacies sell compounded products in bulk,
(http://www.wedgewoodpharmacy.com /animals/index.asp), promoting these professionallylabeled products on the internet and through the mail. Such compounding appears to not be
Close the current window to return to the IVIS website or go to www.ivis.org
Reprinted in the IVIS website with the permission of the AAVPT – www.ivis.org
VETERINARY COMPOUNDING – FORMULATING THE FUTURE
Dawn Merton Boothe, DVM, PhD, DACVIM, DACVCP
College of Veterinary Medicine
Auburn University, AL
Individualized drug therapy increasingly is important to the effective delivery of health
care to both the human and veterinary patient. Accordingly, compounding has enjoyed a
resurgence of importance to drug delivery. Contributing to the recent surge in compounding are
the loss of less lucrative approved drug products as pharmaceutical companies merge, emerging
special needs populations, pharmacogenomics and improvements in the standard of veterinary
care. Among the legitimate benefits provided by veterinary compounding are the
reformulation of drugs to facilitate dosing (e.g., flavored syrups, oral rather than injectable
preparations, transdermal gels) or to reduce the risk of adverse reactions due to over dosing. This
latter service has been a mainstay of veterinary compounding because of the extensive use of
human drugs in animals, reflecting, in turn, the limited number of animal approved drugs.
Compounding has been variably defined by different entities, but the pertinent
components of the definition include prescription driven and clinician-prescribed (or
formulated). Their importance was emphasized in 1997 by the US Supreme Court’s definition of
compounding as “a process by which a pharmacist or doctor combines, mixes, or alters
ingredients to create a medication tailored to the needs of an individual patient.” This definition
is equally applicable to veterinary and human compounding. However, in contrast to human
compounding, legal direction for veterinary compounding exists (the Animal Medicinal Drug
Use Clarification Act of 1994). Neither veterinarians nor pharmacists appear to be well
informed regarding the content or rationale for compounding rules promulgated by the FDA in
response to AMDUCA. Indeed, the pharmacy profession has objected to the Food and Drug
Administration’s perceived interpretation of AMDUCA, including the FDA’s restrictions to
compounding from bulk substances, which stem from a public health perspective. The
compounding profession has actively pursued legislation that will facilitate compounding
veterinary products. From the author’s perspective, these tactics have included a misleading
emotional appeal to the veterinary profession. “Protect the pharmacist’s right to compound”
was the opening page of the IACP website in 2004. It sought veterinary support of legislation
that would legalize compounding, including that from bulk substances, without FDA interference
(http://www.iacprx.org/site/PageServer?pagename=P2C2). Yet, the pharmacists’ right to
compound was not being challenged; indeed, AMDUCA guarantees that right for both
pharmacists and veterinarians. Rather, what was being “challenged” was the use of bulk
substances. Missing in the discussions are reasons that compounding from bulk substances might
be wisely avoided. These include the CVM’s concern regarding compounding in food animals;
this concern might be reduced but not necessarily avoided by a different set of rules for dogs,
cats or horses (for example, how might a legal definition of a food animal assure that any animal
consumed by humans in the USA would be included?). A second concern is assurance of the
quality of the bulk ingredient (see ingredient source below). A third concern is the ease with
which manufacturing may occur once compounding from bulk substances is approved. Indeed,
FDA concern regarding the distinction between compounding and manufacturing has led the
FDA to attempt to legally restrict manufacturing. The first attempt was based on restricted
advertisement (promotion) of compounding services in the Food and Drug Administration Proceeding of 15th AAVPT Biennial Symposium – May 2007, Pacific Grove, CA
Close the current window to return to the IVIS website or go to www.ivis.org
Reprinted in the IVIS website with the permission of the AAVPT – www.ivis.org
Modernization Act of 1996, which was ruled unconstitutional by a US District Court
(infringement of the right to freedom of speech). Subsequent restrictions by the FDA were based
on the regulatory responsibilities of the FDA, which has assumed that any compounded drug is a
new, yet unapproved drug. This distinction allows legal regulatory actions by the FDA.
However, in October of 2006, the Federal District Court of Texas ruled that compounded drugs
were not new drugs, precluding FDA regulatory oversight. Further, compounding from bulk
substances was ruled legal for non-food animals
(http://www.fdanews.com/dailies/drugdaily/2_425/news/59733-1.html). The IACP has declared
this a victory for consumers. In the author’s opinion, suggesting to the public that this ruling,
assured that FDA approval would be expected for each compounded product is a misleading
tactic if not accompanied by an explanation that compounded products undergo no pre-market
assessment, even when mass produced. From the author’s perspective, the intent of the FDA is
not to repress appropriate compounding but to protect the consumer from inappropriate
compounding. Indeed, would a fully informed public be as willing to accept and consume
compounded products?
Not surprisingly, selected compounding pharmacies have extended their compounding
activities well beyond that recognized to be appropriate by the FDA, thus circumventing the
approval process. Internet pharmacies sell compounded products in bulk,
(http://www.wedgewoodpharmacy.com /animals/index.asp), promoting these professionallylabeled products on the internet and through the mail. Such compounding appears to not be
EXTRA-LABEL DRUG USE (ELDU) AND THE ANIMAL MEDICINAL DRUG USE
CLARIFICATION ACT (AMDUCA) –HOW THEY IMPACT THE PRODUCER,
VETERINARIAN,PROCESSOR AND CONSUMER
John R. Middleton
University of Missouri
Columbia, Missouri, USA
Introduction
Therapy of animal disease has evolved significantly over the last 100 years. The introduction of
antibiotics and other therapeutic agents has allowed us to treat infection and better alleviate pain
and suffering. A wide variety of pharmaceutical agents are marketed for treatment of humans
and animals. However, only a minority of these products are specifically labeled for use in
animals with an even smaller subset being labeled for use in dairy cattle. Hence, occasions arise
where a drug must be used in an extra-label fashion, that is, in a manner other than specified on
the product label or package insert. Extra-label drug use (ELDU) is routinely employed by
veterinarians to alleviate pain and suffering in ill animals. The Animal Medicinal Drug Use
Clarification Act (AMDUCA) was enacted in 1994 and provides guidelines for ELDU in
animals.
ELDU
In general, three classifications of drugs are found on dairy farms 1) over the counter (OTC)
drugs, 2) prescription drugs, and 3) OTC or prescription drugs which are not used in according to
label directions. Over the counter products can be purchased without a veterinary prescription.
Prescription drugs are those which must be dispensed by or on the order of a veterinarian and
will carry one of the following statements on the label: “CAUTION: Federal Law restricts this
drug to use on or by the order of a licensed veterinarian” or “CAUTION: Federal Law restricts
this drug to use on or by the order of a physician”.
Extra-label drug use occurs when a product is used in a manner other than specified on the label
such as when a drug is used at a different dosage, dosing frequency, route of administration, in a
different class of animal, or the disease being treated is not specified on the label. When OTC
drugs are NOT used according to the manufacturer’s label directions they require a prescription.
Example:
Drug: Procaine Penicillin G (available OTC)
Label direction: Administer 3,000 units/lb (6,600 units/kg) intramuscularly (IM)
Commonly used dose in dairy cattle: 10,000-15,000 units/lb (22,000-33,000 units/kg)
Commonly used routes of administration: subcutaneously or intramuscularly
Comment: As commonly used this drug requires a prescription from a veterinarian even though
it is available OTC. At the prescribed higher dosage, the label milk and meat withholding times
no longer apply! 22 NMC Annual Meeting Proceedings (2008)
AMDUCA
The Animal Medicinal Drug Usage Clarification Act amended the Federal Food Drug and
Cosmetic Act to allow licensed veterinarians to prescribe extra-label uses of Food and Drug
Administration (FDA)-approved animal and human drugs in animals. Extra-label drug
usage can be prescribed for THERAPEUTIC PURPOSES ONLY (when the health of an
animal is threatened or suffering or death may result from failure to treat) and prescription must
follow the specific guidelines summarized below. Exrta-label drug use CANNOT be practiced
for enhancing production.
Requirements for ELDU (From 21 CFR 530.3 and 530.20 and AVMA Informational Outline of
AMDUCA, 2007)
The following conditions must be met for a permitted extra-label drug use in food-producing
animals.
• There is NO approved animal drug that is labeled for such use that contains the active
ingredient which is in the required dosage form and concentration, except where a
veterinarian finds, within the context of a valid veterinarian-client-patient relationship, that
the approved animal drug is clinically ineffective for its intended use.
• A valid-veterinarian-client-patient relationship exists when:
o A veterinarian has assumed responsibility for making medical judgments
regarding the health of (an) animal(s) and the need for medical treatment, and the
client (owner of animal(s) or caretaker) has agreed to follow the instructions of
the veterinarian;
o There is sufficient knowledge of the animal(s) by the veterinarian to initiate at
least a general or preliminary diagnosis of the medical condition of the animal(s);
and
o The practicing veterinarian is readily available for follow-up in case of adverse
reactions or treatment failure. Such a relationship can only exist when the
veterinarian has recently seen and is personally acquainted with the keeping and
care of the animal(s) by virtue of examination of the animal(s), and/or by
medically appropriate and timely visits to the premises where the animal(s) are
kept.
• Prior to prescribing or dispensing an FDA-approved animal or human drug for extra-label
use in a food-producing animal the veterinarian must:
o Make a careful diagnosis and evaluation of the conditions for which the drug is to
be used;
o Establish a substantially extended withdrawal period for milk, meat, or other
products supported by scientific information, if applicable;
o Institute procedures to assure that the identity of the treated animal or animals is
carefully maintained; and
o Take appropriate measures to assure that assigned timeframes for withdrawal are
met and NO ILLEGAL DRUG RESIDUES or residues which may present a risk
to human health occur in any food-producing animal or food product subjected to
extra-label treatment. NMC Annual Meeting Proceedings (2008) 23
• Use of an FDA-approved human drug or of an animal drug approved only for use in animals
not intended for human consumption must meet the following additional criteria:
o Such use must be accomplished in accordance with an appropriate medical
rationale;
o If scientific information on the human food safety aspect of the use of the drug in
food-producing animals is not available, the veterinarian must take appropriate
measures to assure that the animal and its food-products will not enter the human
food supply.
o Extra-label use of an approved human drug in a food-producing animal is not
permitted if an animal drug approved for use in food-producing animal can be
used in an extra-label manner for the particular use.
• ELDU is permitted only by or under the supervision of a veterinarian, and a valid
Veterinarian/Client/Patient relationship is a prerequisite for ALL ELDU.
• ELDU is allowed only for FDA-approved animal and human drugs.
• Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is
prohibited.
• FDA prohibition of a specific ELDU precludes such use.
Recordkeeping Requirements (From AVMA Informational Outline of AMDUCA, 2007)
• Identify the treated animals either as a group or individuals.
• Record animal species, number of animals, and condition(s) being treated.
• Record the established name and active ingredient of the drug used.
• Record the dosage, dosing frequency, and duration of treatment.
• Record the specified withholding times for milk and dairy beef.
• Records must be kept for 2 years after treatment and the FDA must have access to these
records to estimate risk to public health.
Labeling Requirements (From 21 CFR 530.12)
• Name and address of the prescribing veterinarian and if dispensed by a pharmacy the name
and address of the dispensing pharmacy.
• Established name of the drug or drugs (if formulated from more than one drug).
• Directions for use including the class/species or identification of the animal herd, flock, pen,
lot or other groups of animals being treated; the dosage frequency and route of
administration; and duration of therapy.
What the United States Attorney's Manual Says About Human Growth Hormone/Steriods
Human
Growth Hormone/Steroids Statutory Overview
|
A. Historical overview
1. Prosecuting under the
FDCA
The distribution of anabolic steroids and/or human growth
hormone for muscle enhancement purposes may involve conduct designed both to
defraud the United States and to violate federal law. Since 1938, federal law
has prohibited the distribution of anabolic steroids and/or human growth
hormone outside a legitimate doctor-patient relationship. Originally, the
government's principal legal claim was made under the Federal Food, Drug, and
Cosmetic Act and involved allegations that individuals were distributing
anabolic steroids and/or human growth hormone, both of which are prescription
drugs, without a prescription. See 21 U.S.C. § 353(b)(1)(B).
Pursuant to this statute, prescription drugs such as anabolic steroids and/or
human growth hormone could be legally distributedonly in those
instances in which a physician, based upon an individualized determination of
a proper course of treatment, authorizes the drug's distribution to a patient
under his supervision. See Brown v. United States,
250 F.2d 745, 746-47 (5th Cir.), cert. denied, 356
U.S. 938 (1958); DeFreese v. United States, 270 F.2d 730, 733
& n.5 (5th Cir. 1959), cert. denied, 362 U.S. 944
(1960); see also United States v. Zwick,
413 F. Supp. 113, 115 (N.D. Ohio 1976). If prescription drugs are distributed
outside of this relationship, then the drugs are deemed misbranded. See 21
U.S.C. § 353(b). Distribution of prescription drugs outside these
restrictions has resulted in the prosecution and conviction of
laypersons,[FN1] pharmacists,[FN2] and physicians.[FN3]
FN1. E.g., United
States v. Shields, 939 F.2d 780 (9th Cir. 1991), superseded after remand by,United
States v. Von Mitchell, 984 F.2d 338 (9th Cir. 1993).
FN2. E.g., United
States v. Siler Drug Store, 376 F.2d 89 (6th Cir. 1967).
FN3. E.g., DeFreese, supra; Brown, supra.
If such illegal distribution of anabolic steroids and/or
human growth hormone was done with the intent to defraud and mislead either
consumers or the state and federal government agencies regulating these
drugs, the conduct was punishable as a three-year felony.[FN4] 21 U.S.C. §
333(a)(2); see United States v. Cambra, 933 F.2d 752,
755 (9th Cir. 1991).
FN4.
Using the Federal Food, Drug, and Cosmetic Act, the government must establish
an interstate nexus. Thus, the government must prove either that any one of
the components of the anabolic steroids and/or human growth hormone travelled
in interstate commerce before the drug was misbranded and held for sale, see 21
U.S.C. § 331(k), or the government must establish that the individual caused
the delivery for introduction into interstate commerce of the misbranded
human growth hormone and/or misbranded anabolic steroids, see 21
U.S.C. § 331(a).
2. The 1988 Amendments
In recognition of the fact that illegal drug trafficking
in anabolic steroids and human growth hormone was becoming larger in scope
and presenting an ever-increasing health risk to young athletes, Congress
addressed the issue with two amendments, first in 1988 and then later in
1990. The purpose of both of these amendments was to criminalize steroid and
human growth hormone trafficking.
The first of these amendments was enacted as part of the
1988 Anti-Drug Abuse Amendments, Pub.L. No. 100-690, §§ 2401, 2403, and took
effect on November 18, 1988. The 1988 Anti-Drug Abuse Amendments had two
important components. The first was the creation of a new statute (codified
at 21 U.S.C. § 333(e)(1)) which made the distribution of anabolic steroids
illegal unless (1) it was done pursuant to the order of a physician, and (2)
it was for the purpose of treating a disease. Pub.L. No. 100-690, § 2403. The
second weapon that Congress added in 1988 to the government's arsenal to halt
illegal trafficking in anabolic steroids and/or human growth hormone was the
enactment of Pub.L. No. 100-690, § 2401. This provision, which was codified
as 21 U.S.C. § 333a, gave the government the authority to seek forfeiture of
property for felony crimes relating to any violations of the
Federal Food, Drug, and Cosmetic Act involving anabolic steroids or human
growth hormone. In pertinent part, 21 U.S.C. § 333a, provided:
Any
conviction for a violation of section 303(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. § 333(e)), or any other provision of that Act,
involving an anabolic steroid or a human growth hormone shall be considered,
for purposes of section 413 of the Controlled Substances Act (21 U.S.C. §
853), a conviction for a violation of title II of the Comprehensive Drug Abuse
Prevention and Control Act of 1970, if such violation of the Federal Food,
Drug, and Cosmetic Act is punishable by imprisonment for more than one year.
3. The 1990 Amendments
In 1990, Congress enacted more stringent controls with
higher criminal penalties for offenses involving the illegal distribution of
anabolic steroids and human growth hormone. This new legislation, which was
enacted as part of the Anabolic Steroids Control Act, Pub.L. No. 101-647,
title XIX, §§ 1901-05, resulted in a reconfiguration of the statutory scheme
regulating the distribution of both anabolic steroids and human growth
hormone. The 1990 Act reclassified anabolic steroids as Schedule III
controlled substances, effective February 27, 1991.[FN5] See 21
U.S.C. § 812(c) (1992). The 1990 Act also amended 21 U.S.C. § 333(e)(1) to
explicitly criminalize as a five-year felony the distribution and possession,
with intent to distribute, of human growth hormone "for any use . . .
other than the treatment of a disease or other recognized medical condition,
where such use has been authorized by the Secretary of Human Services . . .
and pursuant to the order of a physician . . . ."[FN6] Pub.L. No.
101-647, title XIX, § 1904 (codified at 21 U.S.C. § 333(e)(1) (1992)). The
1990 Act also provided that criminal forfeiture would be available as an
additional penalty for convictions involving illegal distribution of human
growth hormone under the newly amended 21 U.S.C. § 333(e)(1). See Pub.L.
No. 101-647, title XIX, § 1904 (codified as 21 U.S.C. § 333(e)(3) (1992)).
FN5.
Although U.S.C.A. still lists 21 U.S.C. § 333(e)(1) as prohibiting the
distribution of anabolic steroids, it should be noted this provision has not
been in effect since February 27, 1991.
FN6.
If human growth hormone is distributed to individuals under the age of 18,
the amendments increase the maximum term of imprisonment to 10 years. Pub.L.
No. 101-647, title XIX, § 1904 (codified at 21 U.S.C. § 333(e)(2)).
In 1993, these provisions outlawing the distribution of
human growth hormone for non-medical purposes were recodified at 21 U.S.C. §
333(f) pursuant to Pub.L. No. 103-80, § 3(e), 107 Stat. 775.
B.Practical Considerations
Prosecuting distribution of human growth hormone is
different from virtually any other drug prosecution under the FDCA. Among
other things, proof of interstate distribution of the drug is unnecessary.
Additionally, the mens rearequirement for a felony is
"knowing distribution" or "knowing possession with intent to
distribute," not "intent to defraud or mislead."
Thus, prosecuting non-physicians for distributing human
growth hormone is akin to prosecuting a narcotics case under the Controlled
Substances Act. As a result, establishing liability in such cases is simpler
than for other FDCA offenses. This is particularly true because the only two
authorized manufacturers of human growth hormone (Genentech and Eli Lilly)
have both established stringent restrictions over the distribution of their
products to ensure that only physicians can gain access to the drugs. Under the
current restrictions, only hospital pharmacies can order the drug; local
pharmacies cannot. Thus, most non-physician cases involving the distribution
of human growth hormone will involve one of three scenarios: (1) diverted
human growth hormone, obtained either through theft or via a drug-dealing
physician; (2) smugg |
United States Attorney's Manual Statement on Prosecution for Animal Drugs and Black Markets Including HGH and Animal Drugs
Under the FDCA, Congress has comprehensively regulated
animal drugs. The black market for these animal drugs includes both
foreign-made drugs that do not comply with FDCA requirements, and drugs banned
in the United States. Targets in these investigations include smugglers,
distributors to veterinarians and livestock owners, and veterinarians who
compound such drugs from smuggled raw or bulk ingredients.
The FDCA's regulation of animal drugs has two central aims.
One is to ensure that veterinary drugs are both safe and effective for the
animals that receive them, because unsafe or ineffective drugs may result in
unnecessary economic loss to livestock owners. The other aim is to insure the
safety of the nation's food supply. Unapproved animal drugs, or drugs that are
used in an unapproved manner, may leave dangerous chemical residues in food
derived from treated animals. Such residues pose serious health risks to humans
that ingest them.
The FDCA is structured to achieve its aims through two
complementary approaches. One approach is to require that all "new animal
drugs," 21 U.S.C. § 321(v), be approved as safe and effective by FDA
before being marketed for use. 21 U.S.C. § 360b. Virtually all drugs intended
for animal use are new animal drugs within the FDCA's definition and thus are
required to receive FDA's approval prior to marketing. A drug lacking such
approval is deemed to be adulterated under the FDCA and may not be distributed
in interstate commerce. 21 U.S.C. §§ 331, 351(a)(5), 360b. The other approach
is to require that all drugs be properly labeled so that all users, including
laymen, can use them safely and effectively. 21 U.S.C. § 352. A drug that is
not properly labeled is deemed to be misbranded and may not be distributed in
interstate commerce. 21 U.S.C. §§ 331, 352.
FDA grants pre-market approval to a "new animal
drug" only if its sponsor succeeds in demonstrating that the drug is safe
and effective for its intended uses. To gain approval, the sponsor must submit
a "new animal drug application" ("NADA") bearing extensive,
scientifically rigorous data covering a number of subjects. Such subjects
include the ingredients and composition of the drug; the methods and controls
used in producing the drug; and the extent to which foods derived from animals
treated with the drug may contain chemical residues that pose health risks to
humans. 21 U.S.C. § 360b(b)(1). More specifically, a NADA must describe how the
manufacturer proposes to measure chemical residues in food products derived
from treated animals and must describe any restrictions on use of the drug
necessary to keep such residues at safe levels.
Approval of an NADA, if granted, pertains only to those
particular uses of the drug specified in the application (uses that would
typically be confined to particular animals). 21 U.S.C. § 360b(a)(1). For
instance, an NADA showing safety and effectiveness of a particular formulation
for a disease condition in swine does not allow the manufacturer to claim
similar effectiveness for the disease condition in cattle. Due to the metabolic
differences in species of animals, each new condition must be the subject of an
approval. Moreover, FDA can revoke approval if, at a later time, evidence
demonstrates that a drug is not safe or effective for the particular uses for
which it has been approved. 21 U.S.C. § 360b(e).
Notes from SWOSU Faculty--Compounding Tips for Specific Animals
Compounding liquids for veterinary use often focusses on concentrating the medication and ensuring that the dose is measurable.
- Canine -- Dogs typically exhibit a preference for fixed oils (such as vegetable oils), so that medications may be suspended or dissolved in such a vehicle. The drug may be flavoured with 3-5% chicken, beef, liver, or cheese flavours. Many dogs also enjoy sweet flavours, so that saccharin or some other sweetener (
Avian -- Birds typically require small drops, so the drug must be very concentrated and, typically, sweet.
Livestock -- As noted above, pastes are often used in dosing large animals. These may be prepared using an anhydrous polyethylene base, flavoured to improve palatability. Alternatively, the medication may be incorporated as a feed with 47% sugar and 3% dry apple powder flavour.
- Solid dosages forms may be prepared for use in small or large animals as a flavoured troche or biscuit, to be used as a "treat" for the animal. Troches are prepared as they are for humans. Biscuits may be prepared by incorporating the drug into a dough of
If a pet (dog or cat) will not take medication by any other means, some veterinarians and pharmacists have been successful in formulating a paste that is placed on the animals paws. The animal does not like to have dirty paws and will consequently lick the paste off, thereby providing an oral dosage route.
- Suspensions -- Suspensions are prepared as they would be for human medicine. Common suspending agents include micronised
- Sweetening agents most often used are 0.05% saccharin or 0.1% stevia powder extract. Sweeting agents will often be employed to mask the bitter flavour of the drug.
Many species show a marked preference for specific flavours. Flavours that have proven useful in veterinary practice are summarised in the following table:
| Canine | liver, beef, chicken, cheese, artificial chocolate, peanut butter, malt, molasses, cod liver oil, raspberry, strawberry, marshmallow |
| Feline | fish, tuna, sardine, salmon, cod liver oil, beef, liver, chicken, molasses, peanut butter, butterscotch, cheese |
| Avian | tutti frutti, pina colada, tangerine, grape, orange, banana, raspberry, millet |
| Equine | apple, apple/caramel, caramel, cherry, alfalfa, clover, sweets |
| Bovine | eggnog, anise, alfalfa, maple, molasses, clover |
| Porcine | anis, anisette, cherry, sarsparilla, licorice |
| Caprine | molasses, apple, caramel |
| Poultry | watermelon, vanilla, butternut, corn, milk |
| Reptiles | lemon custard, banana cream |
| Iguanas | cantaloupe, kiwi, orange, watermelon, banana |
| Rodents | lemon custard, banana cream |
| Ferrets | chocolate, peanut butter, fish, beef, fruits, molasses |
| Gerbils | orange, peach, tutti-frutti |
| Guinea Pig | celery, pumpkin |
| Rabbit | carrot, celery, lettuce, banana cream, vanilla, butternut, pineapple |
| Chinchilla | banana |
| Ratites | Bright colours: yellow (emus) and green (ostrich). Flavours (emus): watermelon, kiwi, honey, cantaloupe, strawberry |
| Primates | banana, raspberry, apricot, orange, peach, chocolate |
| Armadillo | liver, beef, canned dog food |
| Elephant | apple |
| Tiger | liver, beef, chicken |
| Zebra | apple |
Flavours that are available for compounding include the following (OS/OM and WS/WM refer to oil or water and soluble or miscible): apple powder WM, apple-ade liquid WM, beef liquid OS, beef liquid WM, cheese liquid OM, cheese liquid WM, chicken liquid WM, chicken liquid OS, chicken-herbs & spice liquid WS, fish liqiud OS, liver liquid OM, liver liquid WM, and liver powder souble. Alternatively, meat-flavoured gravy mixes may be used extemporaneously.
Legal Responsibility in Veterinary Compounding
- Compounding of existing drugs is permitted if specific criteria are met. Compounding is technically illegal if bulk drugs are the source. However, the FDA has adopted the view that it is permissible IF the veterinarian states
- 1) there is legitimate medical need
2) compouding is needed for an appropriate dosage regimen for the species, age, size, and medical condition
3) the product is not available in either veterinary or human form or if a different excipient is required for successful treatment.
- 1) The medication is compounded by a veterinarian or pharmacist
2) A withdrawal time be established if appropriate
3) The pharmacist follows good compounding practices
4) The pharmacist must include on the label
- a) name/address of the DVM
b) active ingredient
c) date dispensed and expiration date (generally the end of therapy)
d) directions for use including the target species
e) cautionary statements, including withdrawal times for milk, slaughter, and egg, where appropriate
f) dispensing information (pharmacist, store, location)
- Drugs that are banned from use in food animals include the following: chloramphenicol, clenbuterol, DES, the nitroimidazoles (dimetridazole, ipromidazole), furazolidone, nitrofurazone (topical is permitted), fluoroquinolones, and vancomycin. Additionally, the sulphonamides are contraindicated in lactating animals except those specifically approved for such use.Prescription Interpretation -- Reading veterinary prescriptions is generally the same as that encountered in human medicine. However, one abbreviation that is unique in veterinary practice is s.i.d., which is interpreted as once a day. Therefore, a script reading digoxin 0.125 mg s.i.d. would be interpreted as digoxin 0.125 mg once a day.
The process of drug approval by the FDA is similar to that for human drugs. However some specific differences do exist. Potentials drugs are classified as Investigational New Animal Drugs (INAD) and applications for use are made under a new animal drug application (NADA). These (or pre-INAD) applications are made to the Centre for Veterinary Medicine (CVM) of the FDA. New drugs must prove safety and efficacy in at least two well-controlled studies, including clinical trials. The CVM reviews that data, ensuring GLPs and the integrity of the data. As with the human approval process, a category does exist for drugs not yet approved. In life-threatening situations, a private practitioner or zoo veterinarian may apply for an Expedited Compassionate Investigational New Animal Drug Exemption (ECINAD). If approved, the ECINAD must comply with routing/receipt requirements as set forth by the CVM.
PCCA Responds to FAQ S.959
PCCA response to:
“Frequently Asked Questions
S.959 – Pharmaceutical Quality, Security and Accountability Act” – Published July 24, 2013 by
proponents of Senate Bill 959
The FAQs are reproduced below in their entirety without alteration along with PCCA’s response.
Text in italics is a verbatim copy from the proponents of S.959’s FAQ.
Pharmaceutical Compounding Q & A – Title I of S.959
On May 22, 2013, the Committee on Health, Education, Labor and Pensions (HELP) approved S.959, the
Pharmaceutical Quality, Security and Accountability Act, by voice vote. In Committee, S. 959 was joined
with S.957, the pharmaceutical track and trace provisions. S.959 now contains two titles. Title I contains
the pharmaceutical compounding provisions, and Title II is drug tracing. Title I clarifies the regulation of
pharmacy compounding. Traditional pharmacy practice will continue to be regulated by the states, and
compounding manufacturers, which compound sterile products without a prescription and ship them
across state lines, will be overseen by the Food and Drug Administration (FDA). Compounding
manufacturers will be required to register and be inspected by the FDA.
PCCA RESPONSE
While Title I of S.959 attempts to clarify the regulation of pharmacy compounding, we feel that
the bill wanders greatly from its intended purpose. The statement “Traditional pharmacy
practice will continue to be regulated by the states,” is disingenuous as many new provisions
and regulations will squarely increase FDA’s role in the regulation of the “traditional” practice of
pharmacy. Also, the promulgation of a new category, called “compounding manufacturers”,
muddies the regulatory waters and places pharmacy practices across the United States in
impossible situations when trying to provide patient care. In the end, S.959 as it stands will
decrease patient access to compounded medications and negatively affect healthcare for
hundreds of thousands, if not millions, of patients.
How does the bill distinguish between pharmacy practice and manufacturing?
continue to read PCCA responses here
“Frequently Asked Questions
S.959 – Pharmaceutical Quality, Security and Accountability Act” – Published July 24, 2013 by
proponents of Senate Bill 959
The FAQs are reproduced below in their entirety without alteration along with PCCA’s response.
Text in italics is a verbatim copy from the proponents of S.959’s FAQ.
Pharmaceutical Compounding Q & A – Title I of S.959
On May 22, 2013, the Committee on Health, Education, Labor and Pensions (HELP) approved S.959, the
Pharmaceutical Quality, Security and Accountability Act, by voice vote. In Committee, S. 959 was joined
with S.957, the pharmaceutical track and trace provisions. S.959 now contains two titles. Title I contains
the pharmaceutical compounding provisions, and Title II is drug tracing. Title I clarifies the regulation of
pharmacy compounding. Traditional pharmacy practice will continue to be regulated by the states, and
compounding manufacturers, which compound sterile products without a prescription and ship them
across state lines, will be overseen by the Food and Drug Administration (FDA). Compounding
manufacturers will be required to register and be inspected by the FDA.
PCCA RESPONSE
While Title I of S.959 attempts to clarify the regulation of pharmacy compounding, we feel that
the bill wanders greatly from its intended purpose. The statement “Traditional pharmacy
practice will continue to be regulated by the states,” is disingenuous as many new provisions
and regulations will squarely increase FDA’s role in the regulation of the “traditional” practice of
pharmacy. Also, the promulgation of a new category, called “compounding manufacturers”,
muddies the regulatory waters and places pharmacy practices across the United States in
impossible situations when trying to provide patient care. In the end, S.959 as it stands will
decrease patient access to compounded medications and negatively affect healthcare for
hundreds of thousands, if not millions, of patients.
How does the bill distinguish between pharmacy practice and manufacturing?
continue to read PCCA responses here
Sunday, July 28, 2013
Sunshine Act: Four Steps to Help Meet August Deadline
Executives at life science companies have known for some time that the final rule implementing the Physician Payment Sunshine Act,¹ part of the Patient Protection and Affordable Care Act, would likely have a significant impact on their operations. The rule requires medical device and drug companies to start tracking payments and “transfers of value”—such as gifts, honoraria and ownership interests—made to physicians and teaching hospitals.
To be in compliance, the tracking must begin on August 1, 2013, and data collected during the next four months must be submitted to the federal Centers for Medicare and Medicaid by March 31, 2014.² “Preparation for complying with the new rule varies considerably among pharmaceutical, medical device and medical supply companies,” says Terry Hisey, vice chairman and principal, Deloitte LLP, and U.S. Life Sciences sector leader.
continue to read article from Deloitte LLP Here
Question of the Day July 28, 2013 U.S Senator Tom Colburn recently said more time and review of the draft Senate Compounding Bill was necessary to see what the industry and stakeholders though. Does Senator Tom Colburn Not realize how much time, input, comments, etc. have gone into this draft of the Senate Compounding Bill Already?
Will More Time Really Make A Difference on this Bill? Compounders are not going to be happy with it No matter what the federal legislation says? How Much Time and Taxpayer Dollar is Congress Going to Spend on this?
Question of the Day July 27, 2013 What Kind of Federal Legislation Short of No Federal Legislation Could Compounders and Compounding Organizations Such As ICAP Find Workable? If a State Was Contemplating Passing Legislation
identical to Senate Bill 959 would compounders and compounding organizations be okay with it?
Compounding Pharmacy Bill Could Be Blocked From Speedy Senate Passage
Senate Health, Education, Labor and Pensions Committee leaders may not achieve their goal of gaining unanimous Senate consent for a modified version of their bill to clarify the oversight of compounding pharmacies.
Committee Chairman Tom Harkin, D-Iowa, and ranking Republican Lamar Alexander of Tennessee plan to request that the bill, with a substitute amendment, be hotlined in the coming days, according to an aide.
But Oklahoma Republican Tom Coburn said Thursday that more time and review was necessary before the bill could be passed under unanimous consent.
“It needs to get out there and be seen by people so we can hear what the industry thinks and everybody that’s a stakeholder thinks,” Coburn said. “Then I don’t have any problem, but [Harkin] shouldn’t do it too soon.”
Asked if before the August recess was too soon, Coburn replied, “I think so.”
continue to read here
VALID POINTS/MUST READ! Lawmakers should go farther on compounded-drug safety
July 28, 2013
MASSACHUSETTS CAN’T make federal officials take responsibility for improving the safety of compounding pharmacies. And until they do, it’s the state’s job to prevent a repeat of the meningitis outbreak that killed dozens of people and sickened hundreds of others and was linked to tainted steroids sold by New England Compounding Center in Framingham. New legislation approved by the Joint Committee on Public Health takes some important steps in protecting consumers and the pharmaceutical supply chain. It’s a good start, but more can be done.
Drugs made by compounders — who mix, combine, or alter ingredients to customize medicine for specific patients — aren’t bound by the same Food and Drug Administration rules that larger drug manufacturers must follow. Ed Markey, then a US representative, introduced federal legislation last year to close this loophole, and Congress should pass it.
In the meantime, Massachusetts needs to address the holes in state regulation of the industry. The bill now before the Legislature, sponsored by Representative Jeffrey Sánchez, should help. It increases ongoing education for pharmacists, establishes a public database of compounders’ track records, and provides funding to continue the unannounced inspections the state has done since the meningitis crisis. The state pharmacy board would also be able to impose fines of up to $25,000 for violations. All are important upgrades. Surprise inspections in February gave clean bills of health to only four of the state’s 40 or so compounders; 11 others were shut down.
continue to read here
Friday, July 26, 2013
Meningitis Sufferer Still Ailing, Pharmacy Policy Up in Air
Danny Lindenberg suffered for a month from the toxic effects of a drug meant to keep him alive, and aside from constant pain, all he said he remembers is chasing rabbits and squirrels through the hospital. The drug caused hallucinations, but those were the milder side effects. His wife, Carolyn, said she remembers watching Danny's eyes roll back into his head and holding his hands as he suffered his first seizure.Each of those initial 28 days was equally chaotic and agonizing, Carolyn said. Today Danny still suffers hallucinations, seizures and debilitating lethargy.Danny, an Evansville resident, was diagnosed with fungal meningitis in November 2012 after contaminated shots infected his spine with black mold.According to the Centers for Disease Control and Prevention, the contaminated shots were sold in 20 states. More than 700 people developed meningitis or other illnesses, and 61 died.Although the company responsible for the outbreak was shut down and the contaminated drugs were eliminated, similar facilities continue to endanger public health, according to a May 2013 report from a U.S. Senate health committee.Since last year's outbreak, at least 48 facilities have produced and sold unsafe drugs.State governments around the nation have increased scrutiny of the industrial-scale compounding pharmacies. These facilities—drug manufacturers in practice—lie outside the scope of stricter regulation because they're technically pharmacies.Now a bill is before the U.S. Senate that would empower the Food and Drug Administration (FDA) to regulate industrial-scale compounding pharmacies like the one that caused the outbreak.Danny and Carolyn said they don't know when his meningitis will subside and when the treatment will stop, but they do know they want the government to prevent these companies from causing another outbreak.Several states need to review their regulatory laws to prevent another outbreak, according to the Senate report.Black particles floated inside syringes at one facility in Florida, according to the report. Dosages in medicines produced by a Texas facility ranged from 62% of the declared amount up to 640%.Between 2001 and 2011, at least 25 deaths were tied to drugs produced and sold by companies like the one that caused last year's outbreak, according to the report. There were 13 deaths in 2011 alone.While dangerous facilities disseminated bad drugs, FDA regulators were halted.A 1997 law extending the FDA's regulation to industrial-scale compounding facilities was rendered unenforceable due to a clause concerning advertising.Although the FDA was defanged, the facilities weren't without regulation. States each have their own agency responsible for overseeing and regulating the facilities.In Indiana, the Board of Pharmacy can revoke pharmacists' licenses, shutting down facilities.The Indiana board is committed to protecting citizens, Director Greg Pachmayr said. Board investigators conduct unannounced inspections in compounding facilities.The pharmacy board is doing the best it can, pharmacy law expert and Purdue University professor G. Thomas Wilder said, but that might not be enough.Indiana's board has a handful of investigators, Wilder said. After last year's outbreak, other states' legislatures expanded their regulatory agencies' budgets and staffs.The Indiana General Assembly hasn't responded to last year's outbreak with similar legislation.Ninety-one people in Indiana developed illness or injury from the outbreak, and 11 died. FDA observers found unsafe conditions at an Indianapolis facility in April. Later that month, the facility recalled all its products, and no injuries or illnesses were reported.The Indiana Board of Pharmacy is probably under-budget and understaffed, State Rep. Steve Davisson, R-Salem, said. Davisson is Vice Chairman of the Indiana General Assembly's Public Health Committee.He said the Legislature will likely wait and see what happens to the bill in Congress. Voting on that bill isn't scheduled yet, so it's far from law.Opponents of expanding FDA regulation to industrial-scale compounding pharmacies say normal pharmacies, which compound every day for individual patients, will suffer greatly under stricter regulation.But the Senate bill is designed to balance regulation between state agencies and the FDA. Indiana's board would regulate small, normal pharmacies, for example, and the FDA would handle industrial-scale compounders.That's a valid fear, Wilder said, because compounding is very important to the healthcare industry.Compounding is the mixing of drug ingredients to the specifications of a physician's prescription. All pharmacists compound, but it becomes a problem when larger facilities employ it on a manufacturing scale.Overregulation of pharmacies conducting compounding can lead to higher costs for consumers. The vast majority of compounders are safe, Wilder said, but some industrial-scale compounders are unsafe.Indiana's board needs that help from the FDA regulating the facilities, Wilder said.While the legislative process grinds on, Carolyn and Danny are reminding others that victims of unsafe compounding need help, too."There are people out there suffering," Danny said. "They're losing their jobs, their houses and their lives."
quoted from here
quoted from here
Pharmacists: Senate Bill Enhances Drug Supply Chain Security, but also Threatens Patient Access to Essential Medications
ALEXANDRIA, Va., July 25, 2013 -- NCPA Concerned with S. 959's Expanding FDA Authority over Small Business Pharmacies
ALEXANDRIA, Va., July 25, 2013 /PRNewswire-USNewswire/ -- National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA issued the following statement today regarding S. 959, legislation that is expected to be considered soon in the full U.S. Senate:
(Logo: http://photos.prnewswire.com/prnh/20100106/DC33253LOGO)
"This legislation is comprised of two major components impacting independent community pharmacies and their patients.
"First, S. 959 seeks to enhance the security of the U.S. pharmaceutical supply chain by adopting national standards and policies, sometimes referred to as 'track-and-trace,' in place of a patchwork of conflicting state laws. NCPA appreciates the sensitivity of Senate and House lawmakers to try and avoid potentially burdensome legislative requirements that may uniquely impact small business community pharmacies, compared to national corporations with large compliance departments. NCPA has worked tirelessly to balance supply chain safety without adding onerous requirements on small business pharmacies. Federal track-and-trace legislation must achieve a common-sense balance between the need for enhanced patient safety and minimizing unreasonable burdens on supply chain stakeholders.
"Second, S. 959 attempts to respond to the tragic 2012 meningitis outbreak caused by the irresponsible actions of the New England Compounding Center and facilitated by a failure of the Massachusetts State Board of Pharmacy and the Food and Drug Administration (FDA), to appropriately coordinate, communicate and take action. When manufactured drugs aren't an option, independent community pharmacists prepare customized medications for patients in accordance with a prescriber's prescription based on the patient's individual needs. Some of the legislation's provisions, although well-intentioned, raise grave concerns as to how this legislation may inadvertently impact the small business community pharmacies that NCPA represents and the patients that they serve.
"For example, the bill would grant FDA unrestricted authority to establish a list of 'do not compound' medications which, based on FDA interpretation, could impact patient access to compounded drugs. Community pharmacies already struggle with growing regulatory mandates, yet the legislation would also require pharmacies to notify FDA, rather than their state Board of Pharmacy, when compounding medications already recognized by FDA as being in short supply. Moreover, NCPA is disappointed that the Senate is avoiding regular order in order to force through the controversial provisions included in S. 959 without adequate consideration, debate or amendments.
"NCPA staff spent countless hours working with Senators and Senate staff to educate them about these concerns. We are grateful that, as a result, the legislation is substantially improved; however, serious concerns remain with the legislation.
"Due to the concerns mentioned above, among others, NCPA recommends lawmakers split S. 959 into two separate bills, one dealing with supply chain safety and the other addressing the meningitis outbreak. Pharmaceutical stakeholders support the approach to enhancing supply chain integrity taken in S. 959. By contrast, significant questions remain regarding the compounding provisions included in S. 959. Lawmakers should move forward with supply chain integrity legislation, and continue to work constructively to resolve the remaining issues on compounding. As the legislative process continues, NCPA looks forward to continuing to work with the Senate and House to ensure any final legislation strikes a proper balance of making certain that future tragedies are avoided while also preserving patients' access to vital compounds."
The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent an $88.5 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 300,000 individuals, including over 62,000 pharmacists. To learn more go to www.ncpanet.org or read NCPA's blog, The Dose, at http://ncpanet.wordpress.com/.
SOURCE National Community Pharmacists Association
ALEXANDRIA, Va., July 25, 2013 /PRNewswire-USNewswire/ -- National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA issued the following statement today regarding S. 959, legislation that is expected to be considered soon in the full U.S. Senate:
(Logo: http://photos.prnewswire.com/prnh/20100106/DC33253LOGO)
"This legislation is comprised of two major components impacting independent community pharmacies and their patients.
"First, S. 959 seeks to enhance the security of the U.S. pharmaceutical supply chain by adopting national standards and policies, sometimes referred to as 'track-and-trace,' in place of a patchwork of conflicting state laws. NCPA appreciates the sensitivity of Senate and House lawmakers to try and avoid potentially burdensome legislative requirements that may uniquely impact small business community pharmacies, compared to national corporations with large compliance departments. NCPA has worked tirelessly to balance supply chain safety without adding onerous requirements on small business pharmacies. Federal track-and-trace legislation must achieve a common-sense balance between the need for enhanced patient safety and minimizing unreasonable burdens on supply chain stakeholders.
"Second, S. 959 attempts to respond to the tragic 2012 meningitis outbreak caused by the irresponsible actions of the New England Compounding Center and facilitated by a failure of the Massachusetts State Board of Pharmacy and the Food and Drug Administration (FDA), to appropriately coordinate, communicate and take action. When manufactured drugs aren't an option, independent community pharmacists prepare customized medications for patients in accordance with a prescriber's prescription based on the patient's individual needs. Some of the legislation's provisions, although well-intentioned, raise grave concerns as to how this legislation may inadvertently impact the small business community pharmacies that NCPA represents and the patients that they serve.
"For example, the bill would grant FDA unrestricted authority to establish a list of 'do not compound' medications which, based on FDA interpretation, could impact patient access to compounded drugs. Community pharmacies already struggle with growing regulatory mandates, yet the legislation would also require pharmacies to notify FDA, rather than their state Board of Pharmacy, when compounding medications already recognized by FDA as being in short supply. Moreover, NCPA is disappointed that the Senate is avoiding regular order in order to force through the controversial provisions included in S. 959 without adequate consideration, debate or amendments.
"NCPA staff spent countless hours working with Senators and Senate staff to educate them about these concerns. We are grateful that, as a result, the legislation is substantially improved; however, serious concerns remain with the legislation.
"Due to the concerns mentioned above, among others, NCPA recommends lawmakers split S. 959 into two separate bills, one dealing with supply chain safety and the other addressing the meningitis outbreak. Pharmaceutical stakeholders support the approach to enhancing supply chain integrity taken in S. 959. By contrast, significant questions remain regarding the compounding provisions included in S. 959. Lawmakers should move forward with supply chain integrity legislation, and continue to work constructively to resolve the remaining issues on compounding. As the legislative process continues, NCPA looks forward to continuing to work with the Senate and House to ensure any final legislation strikes a proper balance of making certain that future tragedies are avoided while also preserving patients' access to vital compounds."
The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent an $88.5 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 300,000 individuals, including over 62,000 pharmacists. To learn more go to www.ncpanet.org or read NCPA's blog, The Dose, at http://ncpanet.wordpress.com/.
SOURCE National Community Pharmacists Association
MUST READ!! Meningitis outbreak: Court filing in meningitis suit points to drug's price [But Price Is Not Suppose to Be a Factor in Compounding but We See It WAS AND IS]
An amended complaint filed in U.S. District Court gives new evidence that officials at Saint Thomas Outpatient Neurosurgical Center began buying steroids from a Massachusetts compounder because it was cheaper, a charge the clinic has consistently denied.
Attached to the complaint filed Thursday in U.S. District Court in Nashville is a series of emails
between an official at the clinic and a salesman for the New England Compounding Center, the shuttered drug company blamed for the national outbreak of fungal meningitis.
The details came in a suit filed by a Kentucky man, Leon Bland, and his wife, Carolyn Bland, who was stricken with fungal meningitis after getting a spinal injection at the Nashville neurosurgical center.
Lawyers for the neurosurgery center have vehemently denied that the outpatient center switched to NECC to cut costs and stated last week that the last bill from the previous provider was $6.50 per vial, the same price as NECC.
C.J. Gideon, the outpatient center’s attorney, said in an email Thursday evening that he had not yet seen the amended complaint and could not respond.
In the first email included in Thursday’s filing, dated May 17, 2011, an NECC salesman wrote to the clinic on May 17, 2011, stating that he had spoken to his manager and “he said he really would like to offer you better to earn your business. What price would we need to give you to earn your business?”
Debra Schamberg, the clinic manager, emailed back stating that if he could get the price below $6.50 per vial, “then we can talk.”
Three days later the salesman emailed back offering a price equivalent to $6.50.
Following that exchange, according to the amended complaint, NECC’s then-current supplier raised its price from $6.49 to $8.95 per vial.
“Saint Thomas was not willing to pay $8.95 per vial of methylprednisolone acetate,” the complaint states.
In a June 10, 2011, email, Schamberg wrote that if the pricing is still $6.50 per vial, “I am willing to do business with you. Let me know what is needed.”
The same day, an exhibit shows, she placed an order for 700 vials.
The suit does not name NECC, which is in bankruptcy, as a defendant, but it does name the company owners and a series of affiliated firms, including a sister drug company, Ameridose LLC.
The amended complaint notes that on Wednesday a bankruptcy judge in Massachusetts issued an order concluding that NECC is insolvent and was insolvent at the time it filed for bankruptcy late last year.
Under the state product liability statute, if the producer of a defective product is bankrupt, the sellers of a defective product can be sued.
Lawyers for Saint Thomas Outpatient say the facility did not meet the definition of a seller, while lawyers for the plaintiffs contend the opposite.
Contact Walter F. Roche Jr. at 615-259-8086 or wroche@tennessean.com.
Attached to the complaint filed Thursday in U.S. District Court in Nashville is a series of emails
between an official at the clinic and a salesman for the New England Compounding Center, the shuttered drug company blamed for the national outbreak of fungal meningitis.The details came in a suit filed by a Kentucky man, Leon Bland, and his wife, Carolyn Bland, who was stricken with fungal meningitis after getting a spinal injection at the Nashville neurosurgical center.
Lawyers for the neurosurgery center have vehemently denied that the outpatient center switched to NECC to cut costs and stated last week that the last bill from the previous provider was $6.50 per vial, the same price
as NECC.C.J. Gideon, the outpatient center’s attorney, said in an email
Thursday evening that he had not yet seen the amended complaint and could not respond.In the first email included in Thursday’s filing, dated May 17, 2011, an NECC salesman wrote to the clinic on May 17, 2011, stating that he had spoken to his manager and “he said he really would like to offer you better to earn your business
. What price would we need to give you to earn your business?”Debra Schamberg, the clinic manager, emailed back stating that if he could get the price below $6.50 per vial, “then we can talk.”
Three days later the salesman emailed back offering a price equivalent to $6.50.
Following that exchange, according to the amended complaint, NECC’s then-current supplier raised its price from $6.49 to $8.95 per vial.
“Saint Thomas was not willing to pay $8.95 per vial of methylprednisolone acetate,” the complaint states.
In a June 10, 2011, email, Schamberg wrote that if the pricing is still $6.50 per vial, “I am willing to do business with you. Let me know what is needed.”
The same day, an exhibit shows, she placed an order for 700 vials.
The suit does not name NECC, which is in bankruptcy, as a defendant, but it does name the company owners and a series of affiliated firms, including a sister drug company, Ameridose LLC.
The amended complaint notes that on Wednesday a bankruptcy judge in Massachusetts issued an order concluding that NECC is insolvent and was insolvent at the time it filed for bankruptcy late last year.
Under the state product liability statute, if the producer of a defective product is bankrupt, the sellers of a defective product can be sued.
Lawyers for Saint Thomas Outpatient say the facility did not meet the definition of a seller, while lawyers for the plaintiffs contend the opposite.
Contact Walter F. Roche Jr. at 615-259-8086 or wroche@tennessean.com.
Compounding Bill In Senate Adds Office Use Provisions
By Derrick Gingery / Email the Author / Jul. 26, 2013
Word Count: 989 / Article # 14130726007 / Posted: July 26 2013 6:00 PM
Executive Summary
New version of compounding bill would allow compounders to produce limited supplies for office use, but schedule for Senate floor action remains to be seen.quoted from here
VERY IMPORTANT CRIMINAL CASE/MUST READ--KUDOS to US ATTORNEY'S OFFICE --Owner of National Respiratory Services LLC and Minority Shareholder pled guilty to charges of misbranding and altering drugs --Caused Compounded Drugs to Be Sent to Patients through Interstae Commerce then submitted false and fraudulent bills indicating that medications were non-compounded
LOUISVILLE, KY—The former owner of National Respiratory Services, LLC (NRS) and a former minority shareholder have pleaded guilty in United States District Court before Magistrate Judge James D Moyer to charges of misbranding and altering drugs, and the company admitted to committing health care fraud, announced David J Hale, United States Attorney for the Western District of Kentucky. Christopher Keegan, age 55, of Lexington, Kentucky, the former owner of NRS, pleaded guilty yesterday to count two of a federal information and agreed to a restitution payment of $2,030,343.11 to the Centers for Medicare and Medicaid Services, jointly and severally with co-defendants. According to the plea agreement, while owner and majority shareholder of NRS, Keegan and others, through NRS, caused compounded medications to be sent to patients, through interstate commerce, which were sub-potent, super-potent, non-sterile, and therefore adulterated and misbranded in violation of the Food Drug & Cosmetic Act. Further, Keegan and others, through NRS, then submitted to Medicare false and fraudulent billings which indicated that the medications they were providing to patients were non-compounded and FDA-approved when they were not.
The total loss of this activity is $2,030,343.11. Compounded medications are not FDA approved, but FDA regulations permit pharmacists to make compounded drugs, including prescription drugs, in limited amounts and under narrow circumstances, for particular patients and at the direction of a physician when other available drugs cannot be prescribed. Also, co-defendant James Rives, age 71, of Louisville, Kentucky, a former minority shareholder of NRS, pleaded guilty yesterday to count two of the federal information and agreed to a restitution payment of $75,996.85. As a result of the plea agreement, the United States will not pursue felony charges of conspiracy to commit health care fraud against Rives for the activity he engaged in during the period of 2006 through 2008 while defendant Rives was associated with NRS.
At sentencing, the defendants face a maximum term of one year in prison, a fine, restitution, and a period of supervised release. In separate indictments, Johnny Perry, of Mt. Washington, Kentucky, the former vice-president of NRS, was charged on August 3, 2011, and pleaded guilty to a five-count felony indictment. Perry admitted that between June of 2006 and June of 2008, as vice-president of NRS, she provided compounded medications to patients, but led both Medicare and the patients’ doctors to believe that the pharmaceutical company was providing non-compounded medications.
Also, Perry admitted to submitting false and fraudulent claims to Medicare for the cost of FDA-approved, commercially manufactured, prescription inhalation drugs, when they were not. Sentencing is scheduled for August 5, 2013, at 11:00 AM in Louisville before Chief Judge Joseph H McKinley, Jr Former NRS pharmacists Leo Parrino and Linda Schmidt pleaded guilty to introducing compounded inhalation drugs that bore false and misleading labeling and represented them to be of greater strength and potency than they actually were. Parrino pleaded guilty to the charge on September 8, 2011 and was sentenced by Magistrate Judge Moyer to one year probation and restitution in the amount of $14,098.24 and Schmidt was sentenced to one year probation and restitution in the amount of $20,000. The case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb and it was investigated by the Food and Drug Administration Office of Criminal Investigations, Health and Human Services Office of Inspector General, United States Postal Inspection Service, and the Federal Bureau of Investigation.
The total loss of this activity is $2,030,343.11. Compounded medications are not FDA approved, but FDA regulations permit pharmacists to make compounded drugs, including prescription drugs, in limited amounts and under narrow circumstances, for particular patients and at the direction of a physician when other available drugs cannot be prescribed. Also, co-defendant James Rives, age 71, of Louisville, Kentucky, a former minority shareholder of NRS, pleaded guilty yesterday to count two of the federal information and agreed to a restitution payment of $75,996.85. As a result of the plea agreement, the United States will not pursue felony charges of conspiracy to commit health care fraud against Rives for the activity he engaged in during the period of 2006 through 2008 while defendant Rives was associated with NRS.
At sentencing, the defendants face a maximum term of one year in prison, a fine, restitution, and a period of supervised release. In separate indictments, Johnny Perry, of Mt. Washington, Kentucky, the former vice-president of NRS, was charged on August 3, 2011, and pleaded guilty to a five-count felony indictment. Perry admitted that between June of 2006 and June of 2008, as vice-president of NRS, she provided compounded medications to patients, but led both Medicare and the patients’ doctors to believe that the pharmaceutical company was providing non-compounded medications.
Also, Perry admitted to submitting false and fraudulent claims to Medicare for the cost of FDA-approved, commercially manufactured, prescription inhalation drugs, when they were not. Sentencing is scheduled for August 5, 2013, at 11:00 AM in Louisville before Chief Judge Joseph H McKinley, Jr Former NRS pharmacists Leo Parrino and Linda Schmidt pleaded guilty to introducing compounded inhalation drugs that bore false and misleading labeling and represented them to be of greater strength and potency than they actually were. Parrino pleaded guilty to the charge on September 8, 2011 and was sentenced by Magistrate Judge Moyer to one year probation and restitution in the amount of $14,098.24 and Schmidt was sentenced to one year probation and restitution in the amount of $20,000. The case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb and it was investigated by the Food and Drug Administration Office of Criminal Investigations, Health and Human Services Office of Inspector General, United States Postal Inspection Service, and the Federal Bureau of Investigation.
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