National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy

Pharmacists Group Lobbies Against 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 continue to read here

Imprimis Pharmaceuticals Innovates Back to Basics With Compounding

CHICAGO(TheStreet) -- Although the number of people needing custom medicines and new ways to take them is growing exponentially, there are few pharmaceuticals companies positioned to take advantage of the trend.

Enter Imprimis Pharmaceuticals (IMMY_).

The California company has a unique combination of delivery methods and partner that make it worthy of attention as more people worry about the harmful long-term effects of certain mass-produced medications.

 

For instance, nonsteroidal anti-inflammatory drugs such as Advil, Motrin and Aleve have been shown in studies to cause stomach ailments. "Gastritis, esophageal reflux disease and bleeding ulcers are all problems that can develop from NSAIDs," says Robert Hoffman, chief of rheumatology at the University of Miami's Miller School of Medicine.

Such mass-produced drugs have developed into a multibillion-dollar industry since industrialization became the norm in the 1950s. Imprimis CEO Mark Baum looks to the era before that, though, when it was common for pharmacists to blend custom prescriptions for individual customers. He thinks his company can make strides to revolutionize modern drug compounding, improving their quality and moving them swiftly through Food and Drug Administration approvals.

Imprimis has a drug delivery technology that ensures site-specific treatment via a topical cream preparation, including with Impracor, a drug entering Phase 3 approvals from the FDA in the third quarter of 2013, and a variety of others that "will enable the delivery of drugs intravenously... as well as through the mouth, through the nose, and trans-vaginally, which gives us the ability... to affect men's health, women's health, as well as [avoid] gastrointestinal conditions," Baum says.

The technology could revolutionize the way pharmaceuticals, especially analgesics, are accessed and administered, Baum says.

Imprimis already uses its Transdel technology to deliver an NSAID called ketoprofen via a cream that is rubbed on the skin, where it acts on the underlying tissues to ease pain.

Imprimis' partner in the revolution is the Professional Compounding Centers of America, "the largest player in the compounding pharmacy industry in North America," Baum says. "The PCCA has over 10,000 proprietary compounded drug formulations and ... more than a dozen proprietary drug delivery technologies," and Imprimis has an exclusive relationship with the PCCA to develop and commercialize its library of patented formulations and technologies -- to mine the library for drugs that can be developed internally or through a development partner.

This library has the potential to provide Imprimis with multiple large-market drug candidates annually, Baum says, saving cost and time. Since all the formulations have been used by the PCCA's patients, ample data are available on their performance and safety that Imprimis can use in putting drugs through the federal 505(b)(2) approval pathway.

"These are drug formulations that are typically sold by ... compounded pharmacies all over the country. Imprimis is taking them through a traditional regulated FDA process in order to bring them to the market," Baum says.

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Tennessee board adds new rules for compounding pharmacies

Tennessee board adds new rules for compounding pharmacies

Duane Morris Has Done Another Great Job of Summarizing the Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

It can be read here:  United States: Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

Last Updated: July 30 2013

Article by Rachael G. Pontikes and Elinor L. Hart

Duane Morris LLP

MUST READ--July 26, 2013 FDA Soliciting Input on Global Supply Chain Provisions in FDASIA --Meeting in August will address compounding questions

In a recent post from the FDA Voice Blog, Office of Compliance Director for FDA's Center for Drug Evaluation and Research (CDER) wrote about the agency's future activities to help combat the globalized supply chain—in particular about the Food and Drug Administration Safety and Innovation Act (FDASIA).

In addition to sharing his priorities about resolving problems regarding drug compounding, Office of Compliance Director Howard Sklamberg noted that one of his main priorities is the globalized supply chain. He noted how today, "nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients come from overseas sources." He also recognized that a "growing number of clinical trials that test the safety and effectiveness of potential new drugs are also moving overseas, making FDA oversight more challenging."

He also identified that "counterfeit drugs are proliferating around the world and sometimes even entering the U.S. supply chain" and the "ever burgeoning worldwide use of the Internet continues to spawn avenues for illegal online sales of medicines of unknown safety and quality."

Confirming other priorities of the U.S. Department of Justice and recent FDA activities, Sklamberg also noted that "poor manufacturing practices that lead to facility shut-downs often contribute to shortages of important drugs," and another agency priority will be to "ensure that wherever drugs are made, wherever their ingredients are from, or wherever and however they are tested and sold, that they meet FDA's strict standards of quality and that they remain in adequate supply."

- See more at: http://www.policymed.com/2013/07/fda-soliciting-input-on-global-supply-chain-provisions-in-fdasia.html#sthash.qri27XjK.dpuf

Two more Michigan deaths linked to tainted steroid injections July 29, 2013

Two more Michigan residents have died in connection with a fungal meningitis outbreak that began last year and has sickened about 750 people nationwide.

A 64-year-old woman and a 75-year-old man, both of Livingston County, died after receiving tainted steroid injections. State health officials confirmed July 22 that their deaths were linked to the outbreak, said Angela Minicuci, public information officer for the Michigan Department of Community Health.

Minicuci said both people had developed epidural abscesses, or infections at the site of injection.

Beginning in May 2012, the Massachusetts-based New England Compounding Center shipped 17,000 vials of contaminated preservative-free methylprednisolone acetate to facilities in 23 states, leading to the deadly outbreak. Steroid shots are a relatively common treatment for back pain.

continue  to read here

 

Court Ruling Threatens Drug Shortage Remedy--May Effect K-V and Compounding Issues

Court Ruling Threatens Drug Shortage Remedy

By JILL WECHSLER | Published: JULY 29, 2013

The Food and  Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the Court of Appeals for the District of Columbia. The ruling of July 23, 2013 also raises broader questions about when and how FDA can “exercise regulatory discretion” in deciding certain  policy and enforcement issues.

According to a unanimous decision by a three-judge panel, FDA’s action to permit import of thiopental from an unregistered foreign establishment was “not in accordance with law,” even though the aim was to address the shortage of a needed medicine. The ruling in Cook et al v. FDA (case No. 12-5176), which upholds a previous decision by a federal district court, involves a shortage of thiopental sodium, which created serious problems for state  

law enforcement

officials seeking to use it in delivering lethal injections. A group of death row inmates from three states filed suit, claiming that FDA violated the law by improperly allowing shipments of a misbranded and unapproved new drug to enter the U.S.

The Appeals Court specifically rejected FDA’s argument that it can legally address drug shortages by permitting the import of drugs approved by other regulatory authorities. Among its various tools for combating serious short supply situations, FDA also cites authority to allow distribution of a product suffering from quality problems, but found by the agency to “not cause undue risk to patients.” Other FDA relief strategies are to work with sponsors to resolve manufacturing issues, expedite inspections and reviews of short supply products, identify additional manufacturers willing to initiate or increase production, extend product expiration dates, and help firms qualify new sources of raw materials.

FDA has permitted unapproved imports 17 times in recent years, according to its announcement in May on authorizing the import of injectable total parenteral nutrition (TPN) solutions. These products are desperately needed by hospitals to treat premature infants unable to eat or drink, as well as cancer patients undergoing gastrointestinal surgeries. In this case, FDA authorized Fresenius Kabi USA to import TPN products from its Norway plant. The agency took this step after American Regent/Luitpold shut down operations at the end of 2012 to address quality issues that left particulate matter in injectable products. In this and other cases, FDA says that it evaluates the overseas drug to ensure that it is of adequate quality and informs doctors of the status of the imported product.

The July Appeals court ruling is regarded as a victory for death penalty opponents, who had pressured other manufacturers to discontinue production of thiopental and other “death drugs.” Yet state officials had urged FDA to appeal last year’s district court ruling in order to obtain needed supplies to carry out executions according to law. In that earlier lower decision, the judge accused FDA of hypocrisy, pointing out that the agency prevents consumers from purchasing medicines over the Internet because it deems the products misbranded and unapproved. The Appeals Court agreed, noting that FDA can address specific shortages through other strategies, such as designating an unapproved foreign drug as investigational to allow its importation.

This legal challenge to FDA use of enforcement discretion also could provide support for K-V Pharmaceuticals, which is challenging FDA’s failure to block competitors from producing the pre-term birth drug Makena (hydroxyprogesterone caproate injection). In this case, explains attorney Kurt Karst of Hyman, Phelps & McNamara, the D.C. District Court has sided with FDA, stating that the agency has the right to refuse to take action to stop pharmacy compounding of the drug. Kurt speculates in the FDA Law Blog that the recent Cook case will have a “huge effect” on how it deals with drug shortages [see www.fdalawblog.net July 23, 2013].

 

quoted from here

Pharmacy Compounding Primer

Pharmacy Compounding Primer
for Physicians
Prescriber Beware
Sarah Sellers1
and Wulf H. Utian2
1 q-Vigilance LLC, North Barrington, IL, USA
2 Case Western Reserve University, Cleveland, OH, USA

this article can be read here

Drug Topics Committee calls for Senate action on updated compounding bill -

 

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The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee called for the Senate to act on its bill to provide clear oversight of compounding manufacturers, following the 2012 fungal meningitis outbreak, and to protect the U.S. drug supply chain from counterfeiting and theft, according to a HELP Committee statement on July 25.

 The updated legislation, S. 959, known as the “Pharmaceutical Quality, Security, and Accountability Act,” includes the “Pharmaceutical Compounding and Quality and Accountability Act” (Title 1) and the “Drug Supply Chain Security Act” (Title 2).

Under Title 1, the bill distinguishes between traditional compounding for humans that will continue to be regulated by state boards of pharmacy and compounding manufacturers that will be regulated by FDA. Compounding manufacturers are defined as manufacturers that produce sterile products without, or in advance of, a prescription and then sell across state lines.

Title 1 still allows traditional compounding pharmacies to compound for healthcare practitioners for office use, but sets the limit to 10% of products that the compounding pharmacy can dispense. Within 14 days of dispensing, the pharmacies must reconcile the names of patients who will receive the office use product, the HELP Committee noted.

FDA will be able to develop a list of drugs that cannot be compounded and bulk ingredients that cannot be used in compounded products. Also, there is be streamlined notice for compounding during a drug shortage, which allows for a single notice by the compounder that is copying an FDA-approved drug, according to Title 1.

Compounding manufacturers will only be able to compound nonsterile drugs from a list developed by FDA. However, they will be allowed to repackage biologics without a prescription. All compounding manufacturers will be listed on the FDA’s website, including the state where they are registered. When compounding manufacturers register, they must include a list of products that they produced in the last 6 months.

“This bill is about saving lives, plain and simple. The most recent compounding outbreak resulted in 61 deaths. More than 700 people continue to suffer from tainted compounded medicine. We must find reasonable ways to prevent further death or illness due to confusion over who has oversight of compounding pharmacies,” said Sen. Pat Roberts (R-Kan.) during the release

JUL 29, 2013

 of this updated bill.

Under Title 2, within 4 years of enactment of this legislation, all prescription drugs will be tracked from the manufacturer to the pharmacy. Manufacturers will have to serialize their products, provide transaction information, transaction history, and transaction statements in an electronic format to their trading partners.

“This bill establishes a uniform system that improves the security and safety of drugs for consumers,” Sen. Richard Burr (R-N.C.) said during the release of the updated legislation.

quoted from here

 

Senators Propose Amendments To S. 959-RX Trace

As many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week.  Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did.  The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout.  Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable.

Most significantly, manufacturers would be required to provide their transaction information, transaction history, and transaction statement in a single document only in electronic formstarting 4 years after enactment.  Prior to that point they could provide it in either electronic or paper form.  What’s interesting about this change is how it would trickle down the supply chain.

On the surface you would expect that the authors of the bill would need to include a similar requirement on the wholesalers, dispensers and repackagers, but they did not do that.  It is not necessary because, wholesalers were already required to receive that information from the manufacturer.  Once the manufacturer can only provide it in electronic form 4 years after enactment, then wholesalers must be able to receive and store it electronically to remain in compliance at that same time.

Once wholesalers begins to receive the transaction information, history and statements from the manufacturers in electronic form it appears that the bill would allow them to convert them to paper whenever they need to pass them on to their customer.  That is, at least until the enhanced drug distribution security provisions would kick in 10 years after enactment.  By that time, everyone would have to create, store and exchange these documents electronically.

But this brings me to the next significant amendment to the bill.  There is a new and poorly worded section under the Product Tracing section called “Trading Partner Agreements”.  The section says:

continue to read here

FDA CDER Schedule for Guidance Agenda: for 2013

Guidance Agenda:
New & Revised Draft Guidances CDER is
Planning to Publish During
Calendar Year 2013
(See the Good Guidance Practices (GGPs) regulation on this Web page or
21 CFR 10.115 for details about the Guidance Agenda.)
CATEGORY —Advertising
• Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials
including Submissions in Electronic Format
CATEGORY — Animal Rule
• Product Development Under the Animal Rule
CATEGORY — Biopharmaceutics
• Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence
Studies for Orally Administered Drug Products Submitted in New Drug Applications General
Consideration

CATEGORY — Biosimilarity
• Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein
Products
CATEGORY —Chemistry
• Allowable Excess Volume and Labeled Vial Fill Size
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in
Abbreviated New Drug Applications
• CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological
Products
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Elemental Impuritiesin Drug Products Marketed in the United States
• Immunogenicity Considerations for Low Molecular Weight Heparin
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling
Documentation Version: 07.26.13. Guidances with (*) indicates an addition since previous posting.
CATEGORY —Clinical/Antimicrobial
• Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of
Serious Bacterial Disease
• Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
• Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
• Pulmonary Tuberculosis: Developing Drugs for Treatment
CATEGORY —Clinical/Medical
• Alzheimer’s Disease: Developing Drugs for the Treatment of Early State Disease
• Common Issues in Drug Development for Rare Diseases
• Developing Drug and Biological Products for Analgesic Indications
• Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
• Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
• Standards for Clinical Trial Imaging Endpoints
CATEGORY – CMC and CLINICAL/MEDICAL
• Immunogenicity Assessment for Therapeutic Protein Products
CATEGORY —Clinical Pharmacology
• Bioanalytical Methods Validation

CVM Offices Instructional Videos

CVM Offices Instructional Videos

Pharmalot ed Silverman Reports that Pharmacists Group Lovvies Against to Seante Compounding Bill

Posted Mon, 07/29/2013 - 9:11am by Ed Silverman 0

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.

continue reading here

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 Medicne: Overview for Pharmacits Powerpoint

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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
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.

Press Announcements FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement

Press Announcements FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement

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