Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, July 29, 2013
Pharmalot ed Silverman Reports that Pharmacists Group Lovvies Against to Seante Compounding Bill
PHARMACISTS GROUP LOBBIES AGAINST TO SENATE COMPOUNDING BILL
Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is “anti-pharmacy” and is relying on a parliamentary maneuver that may stifle further debate.
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Jul 29, 2013, 6:45am EDT Judge in NECC Says victims Can Sue Health Care Providers
- Craig Douglas
- Managing editor/online vertical products and research-Boston Business Journal
- Email | Twitter
A U.S. bankruptcy judge has cleared the way for victims in the deadly meningitis outbreak that originated in a Massachusetts compounding pharmacy to sue the health care facilities and providers who prescribed the tainted steroids at the center of the controversy.
According to Reuters.com, there were approximately 65 health care providers and doctors in Tennessee who were included on the customer list of the now-insolvent New England Compounding Center in Framingham. The pharmacy and its affiliates stand accused of shoddy operating practices and other regulatory violations that led to the alleged shipment of fungus-tainted steroids to health care providers throughout the country.
The Reuters report said U.S. BankruptcyJudge Henry J. Boroff on July 24 declared NECC insolvent, meaning Tennessee victims can file product-liability claims against medical providers who prescribed the steroids that led to the meningitis outbreak. The newswire said that without the insolvency declaration, the victims would only have been able to pursue professional or medical negligence claims, according to Tennessee law.
The meningitis outbreak has resulted in 15 deaths and 153 meningitis-related cases in Tennessee, according to the U.S. Centers for Disease Control and Prevention.
The outbreak was detected late last year and resulted in a firestorm of legal and civil suits filed against NECC, which filed for Chapter 11 bankruptcy protection shortly after the outbreak made national headlines.
quoted from here
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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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
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.
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