U.S. Food & Drug Administration (FDA)

The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.

FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations regarding safe withdrawal intervals of drugs and chemicals in food-producing animals. As such, FARAD is a key resource for protection of our nation’s food supply, including meat, milk and eggs, against accidental contamination of animal-derived foods with violative residues of drugs, pesticides or other agents that could compromise food safety.”

FARAD regularly provides guidance to the food animal producing industry and veterinarians regarding “the use of therapeutic drugs, pesticides and other agents that improve overall animal health and promote safe, efficient and humane production practices.”

The purpose of its latest digest, as stated, “was to provide US veterinarians guidance regarding ELDU in small ruminants. The lack of FDA-approved drugs for sheep and goats frequently necessitates ELDU in those species. When the FDA approves a drug for use in a particular species, it establishes a tolerance or that drug in the various tissues or products (eg, milk or eggs) of that species that might be consumed by people. When a drug not labeled for use in a small ruminant is administered in an extralabel manner, there is a zero tolerance for residues of the parent drug or its metabolites in the edible tissues or products of treated animals, and detection of the parent drug or metabolites in any product marketed for human consumption is considered a violation and subject to regulatory action. Given the lack of tolerance and pharmacokinetic and tissue depletion data for many drugs administered in an extralabel manner to small ruminants, extended meat and milk WDIs are generally required to ensure that drug residues are undetectable. Veterinarians need to be cognizant of the requirements for legal ELDU in food-animal species to safeguard the human food supply while continuing to promote the health and welfare of small ruminants.”

As a former owner of a veterinary large animal practice in which 50% of my patients were small ruminants (goats, sheep, alpaca and llama), it was imperative to be able to prescribe or administer drugs in an extralabel manner to provide humane care and prevent animal suffering.

Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.  21 CFR 530.3.

Some of these uses have included medications added to commercial feeds, that are now governed under the Veterinary Feed Directive that FDA enforces for use in major, but not minor species.

According to guidance from FDA, “many commercial medical feeds that require a VFD are not approved for use in minor species,” defined by FDA as all species other than cattle, horses, swine, chickens, turkeys, dogs, and cats.  Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species.  A veterinarian may consider ELDU of medicated feed in minor species if:

There are no approved treatment options available;

The health of the animals is threatened; and

Failure to treat the animals would result in suffering or death.

The veterinarian must provide a written recommendation that includes the medical rationale for ELDU of medicated feed.

Before a veterinarian can provide such professional guidance, a valid veterinarian-client-patient relationship (VCPR) must exist.  While state laws govern the practice of veterinary medicine, including such relationships, FDA has inserted itself in the equation by identifying which states do not require the elements of a VCPR that FDA considers sufficient for the purposes of enforcing its Veterinary Feed Directive and other federal laws.

These multilayered state and federal laws can be difficult for veterinarians and small ruminant producers to decipher—hence the necessity of FARAD and other agencies to provide more specific guidance.

State Departments of Emergency Management prepare and respond to natural disasters by implementing the orchestrated emergency response plans, which state, federal and non-profit partners help develop over the years. These plans, that also include responses to the intentional or accidental introduction of highly pathogenic zoonotic or strictly animal diseases, are considered ever-green and updated based on emerging technology and review of tabletop exercises.

For those farmers, ranchers, veterinarians, zoos, aquaria, equine facilities, animal shelters, pet stores, biomedical research facilities and companion animal owners in need of assistance following Hurricane Florence and then Hurricane Michael in the South East, I hope the following resources can be of assistance.

South Carolina

On October 8, 2018, South Carolina State Veterinarian Boyd H. Parr, DVM implemented “temporary exceptions to the regulations governing the importation and exportation of animals coming into and leaving South Carolina as a result of Hurricane Michael.  All animals moving under these exceptions are expected to return to their state of origin no later than 10/31/18 unless this order is extended or revised.”  The exceptions, set forth at the Clemson Livestock Poultry Health website, permit interstate movement without a Coggins test result form or Certificate of Veterinary Inspection.

A comprehensive list of resources are available on Clemson’s Emergency Preparedness, Response and Recovery website, including, for example, links to (1) Hurricane Guidance for Livestock Owners; (2) Disaster Plan for Horses; (3) Emergency Equine Stable Sites; Flooding Hay Request Form; (4) Animal/Agriculture Emergency Support Function (ESF)-17 Ag Damage Assessment Information Form; and (5) Business Continuity for Agriculture/Secure Food Supply Plans.

In the face of Hurricane Florence, South Carolina previously suspended certain motor vehicle requirements, including, “such federal rules and regulations, in conjunction with S.C. Code Ann. §§ 56-5-4010 et seq., which establish size, weight, and load requirements for South Carolina highways, for, in relevant part, “Persons and vehicles transporting livestock, poultry, food for livestock and poultry, and crops ready to be harvested.”

Georgia

In Georgia, the Department of Agriculture has a Hurricane Response Center available on its website that also provides links to relevant information, including tips for those impacted by the storm.  Guidance is available related to livestock, pets, food, fuel, crops and other important information, such as:

0/12/2018 Commissioner Black Gets First Glimpse of Hurricane Michael’s Damage

10/12/2018 Disaster Assistance Discovery Tool

10/11/2018 Hurricane Michael Devastates Georgia’s Agricultural Industry

10/10/2018 Disaster Assistance Fact Sheet

10/10/2018 Press Release: Georgia Department of Agriculture Responds to Threat of Hurricane Michael

10/10/2018 Hurricane Michael: Animal Interstate Movement Requirements for Entry into Georgia from Florida are Temporarily Suspended UPDATED!

10/09/2018 Georgia National Fair Press Release: Fair Closed Wednesday October 10th, 2018

10/09/2018 Governor Nathan Deal declared a state of emergency for 92 counties in Georgia

Resources for Animal Food Producers in Flooded Areas of Gulf Coast

Like South Carolina, Georgia  and Florida temporarily suspended their interstate importation requirements for the transportation of animals.

Florida

Florida, with its long history of exemplary emergency preparedness and response, continues to implement those plans, including “[s]upporting pet-friendly shelters, agricultural producers, and local communities with various needs for supplies, transportation and staffing.”

North Carolina

The North Carolina Department of Agriculture & Consumer Services, N.C. State University Cooperative Extension and N.C. Cattlemen’s Association issued a warning on Sept. 22, 2018 to its constituents that “an individual was offering operational recovery assistance to producers with the claim that he had been authorized by the South Carolina state government. A background check on this individual proved this to be false.”

We are asking that if you are contacted by organizations or individuals that you do not know and you have a concern about their legitimacy, to please get the name of the individual/team, phone numbers, emails, license plate numbers, etc. and share that with your county Emergency Management Services.

USDA

A long-time partner with state departments of agriculture in emergency response, USDA provides resources and information on its website.  Its role  is “to provide food, emergency housing, community, as well as farmer and rancher assistance to individuals and small businesses affected by severe storms and flooding . . . [and] to work with states affected by severe storms and flooding regarding requests for various assistance, waivers and flexibilities in administering federal nutrition assistance programs.”  USDA also provides link to FEMA’s app for shelter and related information, as well as disaster assistance programs for farmers.

FDA

FDA, concerned about contamination of crops from floodwaters, provides relevant guidance on its website, “Crops Harvested from Flooded Fields Intended for Animal Food: Questions and Answers.”  In some cases, and with specific FDA approval, crops intended for human consumption can be used for animal feed.

The FDA will work with producers to consider requests to recondition an adulterated crop into animal food on a case-by-case basis. FDA’s compliance guide (CPG 675.200) provides a step-by-step process for reconditioning requests.

AVMA

The AVMA helps veterinarian impacted by disasters and provides emergency preparedness guidance on its website.

Hopefully, everyone impacted by these recent storms will find these and other resources helpful as they rebuild their properties, care for their animals, and recover.

As part of its Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings—just released—FDA announced that it plans to shift from “educating” food animal veterinarians and producers about the 2016 Veterinary Feed Directive (VFD) to “ensuring compliance with the . . . regulation to further ensure the safety of animal and human health.”  In other words, producers, veterinarians, and VFD medicated feed distributors (e.g., feed mills, retailers) should expect enhanced enforcement by FDA inspectors.

Those regulated should keep in mind that FDA inspectors will “examine VFD orders, requirements for the parties involved, and recordkeeping” during inspections.

FDA’s overall plans include three broad-based goals:

  1. Align antimicrobial drug product use with the principles of antimicrobial stewardship;

  2. Foster stewardship of antimicrobials in veterinary settings; and

  3. Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals.

While described as a One Health initiative, FDA’s plans favor the preservation of medically important antibiotics for humans over animals, particularly food animals.  Also, while acknowledging that it does not regulate either veterinary medicine or farming activities, FDA has set forth plans that appear to attempt to extend their regulatory reach, through proposed expansion of inspection and testing of animals, including food animals, companion animals, animal feed, farm-raised seafood and retail meat.

FDA also plans on bringing the 5% of antimicrobials still available over the counter under veterinary oversight, including, for example intramammary treatment to prevent or treat mastitis.  Not only will this increase costs to producers (which will be passed along to consumers), but according to the AVMA, many farmers and ranchers in rural communities do not have access to adequate veterinary care because of veterinary shortages “in more than 180 rural communities across the country.”

Certainly, the issue of antimicrobial resistance is important.  However, the emphasis by some government officials and legislators too often focuses on limiting use of antibiotics important to maintain the health of animals.  And the collection and reporting of antibiotic use and test results are used by activists to eliminate the use of animals for food completely.

Testing of some food products, albeit for other purposes, resulted in the conviction of the owners and operators of the Decoster Egg Farms for “introducing eggs into interstate commerce that had been adulterated with Salmonella enteritidis,” even though the government admitted that it had not identified any personnel, including the defendants who knew that the eggs were contaminated.  United States v. Decoster, 828 F.3d 626 (8th Cir. 2016) (Beam, J., dissenting).

Keep in mind that preventing Salmonella enteriditis was the basis for the adoption of enlarged cage requirements for hens in California despite evidence that such measures do not decrease the prevalence of the bacteria.  Furthermore, California and Massachusetts have imposed their regulations on producers in other states—an impermissible extraterritorial regulation in violation of dormant commerce clause, which has been challenged.  State of Missouri, et al. v. State of California, No. 22O148 (2017); State of Indiana, et al. v. Commonwealth of Mass., No. 22O149 (201

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans and animals.

Esteemed scientific associations (listed below) wrote to Congressional representatives, in opposition to H.R. 3197, explaining that while scientists embrace efforts to reduce the number of animals needed in research and to replace animals when possible, animal models are still required before drugs or devices are sufficiently proven to be both safe and efficacious for their intended use.  While the number of dogs involved in biomedical research has been reduced, their contribution remains critical in finding cures for certain diseases and disorders, like the previously incurable and fatal genetic disorder affecting skeletal muscles in both humans and dogs, called Myotubular Myopathy (MTM), recently described here.

Canines are currently playing a vital role in the moonshot to end cancer, aging and Alzheimer’s, heart disease, diabetes, and most recently the first FDA-approved artificial pancreas was brought to fruition because of work at the VA. Additionally, 22 of the 25 most prescribed medications were brought to patients’ bedsides thanks to research with canines.

Quote from letter to Congressional representatives from:

  • American Academy of Neurology (AAN);
  • American Association for Laboratory Animal Science (AALAS);
  • American College of Neuropsychopharmacology (ACNP) ;
  • American Neurological Association (ANA);
  • American Society of Laboratory Animal Practitioners (ASLAP);
  • American Society for Pharmacology & Experimental Therapeutics (ASPET);
  • American Thoracic Society (ATS);
  • Americans for Medical Progress (AMP);
  • Associated Medical Schools of New York (AMSNY);
  • Association for Research in Vision and Ophthalmology (ARVO);
  • Association of American Medical Colleges (AAMC);
  • Association of American Universities (AAU);
  • Association of American Veterinary Medical Colleges (AAVMC);
  • Association of Public and Land-grant Universities (APLU);
  • Baylor College of Medicine California Biomedical Research Association (CBRA);
  • Coalition for the Life Sciences The College on Problems of Drug Dependence, Inc. Comparative Biosciences, Inc. Council On Governmental Relations (COGR);
  • Federation of American Societies for Experimental Biology (FASEB);
  • IACUC 101 Series Massachusetts Society for Medical Research (MSMR);
  • Michigan Society for Medical Research (MISMR);
  • National Animal Interest Alliance (NAIA) National Association for Biomedical Research (NABR);
  • National Association of Veterans’ Research & Education Foundations (NAVREF);
  • New Jersey Association for Biomedical Research (NJABR);
  • North Carolina Association for Biomedical Research (NCABR)
  • Northwest Association for Biomedical Research (NWABR);
  • Oregon Health & Science University (OHSU);
  • Pennsylvania Society for Biomedical Research (PSBR);
  • RxGen SNBL USA, Ltd. Society for Neuroscience (SfN);
  • Society for the Study of Reproduction (SSR);
  • States United for Biomedical Research (SUBR);
  • Texas Society for Biomedical Research (TSBR); and
  • University of California, Los Angeles University of Illinois Urbana-Champaign Washington University in St. Louis.

Our ability to study and find cures for many human and animal diseases and disorders would not have been obtainable without studies involving animals, including the following medical achievements:

  • the cardiac pacemaker;
  • the first liver transplant;
  • nicotine patch;
  • the discovery of insulin;
  • vaccinations against canine distemper, parvovirus, rabies, coronavirus, leptospirosis, Lyme disease, measles, and hepatitis;
  • prevention of canine intestinal parasitic diseases, fleas, ticks, mites and mange.

Like the entities listed above I look forward to a time when biomedical research does not involve animal testing, but we currently are not knowledgeable or scientifically advanced enough to entirely replace animals with other models.

Therefore, federally proposed bills, including H.R. 3197 and a similar amendment offered by Rep. Dave Brat (R-VA) to the Defense, Military Construction, Veterans Affairs, Legislative Branch, and Energy and Water Development National Security Appropriations Act, 2018, if adopted, would only serve to harm both human and animal health, and should therefore be opposed.

 

FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications are available for treating their pets.  For example, while serving on the New Jersey State Board of Veterinary Medicine, I recall a fair number of consumer complaints that alleged that a veterinarian provided substandard medical care because the medication prescribed to a pet was labeled “for human use only.”  Consumers therefore concluded that the medication harmed their pet.

However, the fact that medication is not specifically approved for use in animals does not mean that it would necessarily be harmful to those animals.

In fact, the use of an approved drug in a manner that is different than stated on the label, has been a fundamental tool used in veterinary medicine since drugs were first labeled.  This “extralabel” drug use was memorialized by Congress in the Animal Medicinal Drug Clarification Act of 1994 (AMDUCA).  See AVMA’s description of AMDUCA.

As AVMA describes on it’s website, “Compounding: FAQ for Veterinarians,” “compounding for animal patients . . . [is] a subpart of  [the] Extralabel Drug Use (ELDU) Rules.”

The ability to use approved drugs in species, for treatments, or at dosages, frequencies, or routes of administration that are not included on the label, is a tool that veterinarians use on a daily basis.  Since obtaining drug approvals for all uses in all types of animal species is cost-prohibitive, the only way some animals can be treated is through the use of drugs in an extra-labeled fashion.

When used properly and pursuant to the standard of care in veterinary medicine, such use should be considered legal.

While FDA has stated that “[c]urrent law does not permit compounding of animal drugs from bulk drug substances,” whether, and to what extent FDA governs compounding in the veterinary space has been the subject of legal debate.

However, FDA’s withdrawal of its guidance document related to compounding animal drugs from bulk substances creates even more confusion and uncertainty for the regulated community.  The now withdrawn guidance document,  Guidance #230, had set forth the situations in which FDA had indicated that it would not take regulatory action against a pharmacy or veterinarian when “an animal drug compounded from bulk substances may be an appropriate treatment option.”

Now, instead of finalizing the draft guidance based on comments received, “FDA intends to publish the new draft in early 2018 for public comment.”

So, the regulated community will be without guidance for a short period of time.

Hopefully FDA’s new guidance will continue to permit compounding from bulk substances when needed to provide adequate medical care for animals in need thereof.

 

After a whirlwind of comments and criticisms, USDA has updated its statement regarding the abrupt deactivation of its Animal Care Search Tool, available here https://content.govdelivery.com/accounts/USDAAPHIS/bulletins/185b051.

Similar to statements published on interested parties’ websites, USDA confirmed that this decision was based on internal discussions and review that predated the new administration.

In 2016, well before the change of Administration, APHIS decided to make adjustments to the posting of regulatory records.

USDA noted that the deactivation resulted not only based on guidance from the Department of Justice (see Department of Justice Guide to the Freedom of Information Act and Overview of the Privacy Act), that provides a comprehensive review of litigation related to FOIA and the Privacy Act, but that their action was also related to litigation “APHIS is currently involved in . . . concerning, among other issues, information posted on the agency’s website.”

USDA/APHIS did not identify which litigation it referenced in its updated statement.

Like USDA, many federal agencies struggle to balance transparency with personal and business protections required by federal law.

 Recently, PETA (largely) lost it’s lawsuit against HHS, alleging that the Centers for Disease Control and Prevention had impermissibly withheld information pursuant to PETA’s FOIA request “seeking records submitted by importers of nonhuman primates . . . to CDC pursuant to certain agency regulations.”   People for the Ethical Treatment of Animals v. United States Department of Health and Human Services, No. 15-cv-309, slip op. (D.D.C. January 5, 2017).

In the final Order, the Court granted Defendant’s Corrected Motion for Relief under Fed. R. Civ. P. 60(b) holding:

“The four categories of information the Court previously held qualified for protection pursuant to FOIA Exemption 4 with respect to the records of seven objecting importers—quantity of animals imported, the descriptions of crates used in shipments, the names of the companies that export the animals, and the names of the airline carriers that transport the animals—also qualify for such protection with respect to the records of Central State Primate (‘CSP’), Dallas Zoo Management (‘DZM’), and SBNL USA (‘SNBL’). It is further ORDERED that Plaintiff’s [52] Cross-Motion for Relief under Fed. R. Civ. P. 60(b) is GRANTED-IN-PART and DENIED-IN-PART. Plaintiff’s motion is GRANTED in that information regarding the quantity of animals imported and the descriptions of crates used in shipments on the records of Worldwide Primates, Inc. (‘WWP’) and Primate Products Inc. (‘PPI’) does not qualify for protection pursuant to FOIA Exemption 4. Plaintiff’s motion is DENIED in all other respects.  Id., slip op. (D.D.C. Feb. 6, 2017).”

PETA has appealed this decision.

In preparation for the VFD final rule, which outlines the revised process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed and that require the supervision of a licensed veterinarian), FDA released it’s final version of its industry guidance #233 titled “Veterinary Feed Directive-Common Format Questions and Answers.”

While rejecting a suggestion that FDA require a uniform veterinary feed directive form, FDA has provided a “common VFD format [that] would help veterinarians, their clients (i.e., animal producers), and distributors (including feed mills) quickly identify relevant information on the VFD.”

In addition to providing a list of information that is required, FDA has provided a blank VFD form and several examples of completed forms, several of which are reproduced below.

Blank VFD form
Blank VFD form
Example 1 VFD form
Example 1 VFD form
Example 2 VFD form
Example 2 VFD form

Example 2 VFD form

The information that must be included pursuant to § 558.6(b)(3) on any form utilized includes:

the veterinarian’s name, address, and telephone number;

the client’s name, business or home address, and telephone number;

the premises at which the animals specified in the VFD are located;

the date of VFD issuance;

the expiration date of the VFD;

the name of the VFD drug(s);

the species and production class of animals to be fed the VFD feed;

the approximate number of animals to be fed the VFD feed by the expiration date of the

VFD;

the indication for which the VFD is issued;

the level of VFD drug in the feed and duration of use;

the withdrawal time, special instructions, and cautionary statements necessary for use of

the drug in conformance with the approval;

the number of reorders (refills) authorized, if permitted by the drug approval, conditional

approval, or index listing;

the statement: “Use of feed containing this veterinary feed directive (VFD) drug in a

manner other than as directed on the labeling (extralabel use), is not permitted.”;

an affirmation of intent for combination VFD drugs as described in § 558.6(b)(6); and

the veterinarian’s electronic or written signature.

It would be surprising if veterinarians did not use the forms suggested by FDA to insure they were providing all the information required.

Not everyone is satisfied by the increased restrictions set forth by FDA regarding antibiotics for food animals provided in feed and/or water.

A number of nonprofits filed a citizen petition under section 512(e) of the Food, Drug, and Cosmetic Act, 21 U.S.C. Section 360b(e), “to request that the Commissioner of Food and Drugs withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes.”

These nonprofits want to prohibit the use of critically important antibiotics that prevent disease in food animals.  Such use is imperative to continue to protect food animals from preventable illness.

FDA, gearing up for the implementation of the Veterinary Feed Directive (VFD), recently “issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.”

As reported in the Daily Herald, those servicing livestock producers in Utah have also been trying to spread the word:

“Local veterinarians, feed suppliers and livestock producers gathered in Lehi on Thursday to learn how the federal feed directive, which goes into effect on Jan. 1, will affect their operations.

The meeting is just one of a series of meetings being held across the state to make sure livestock producers aren’t taken by surprise when the new directive takes effect. It is expected to affect almost everyone who raises animals for human consumption — from 4-Hers to turkey farmers to bee keepers.”

The VFD sets forth “the process for authorizing use of VFD drugs and provides a framework for veterinarians to authorize the use of medically important antimicrobials in feed when needed for specific animal health purposes” as reported by Lydia Zuraw on JUNE 3, 2015 at Food Safety News.

FDA announced that the final rule is:

“an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health.”

Notably, as previously discussed here, the rule memorializes the concept that veterinarian may only prescribe antibiotics to animals “within the context of a veterinarian-client-patient relationship (VCPR), which includes sufficient knowledge of the animal, visits to the farm, and follow-up evaluation or care.”

While many states include that requirement in state veterinary medical practice acts, not all states include a definition of or specifications for the “veterinarian-client-patient relationship.”  (See table of state laws compiled by AVMA).

The VFD will require veterinarians to follow state-defined VCPR requirements as long as the state requirements include the key elements in the final VFD.

FDA requires:

“the veterinarian engage with the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care.”

However, “where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements.”

FDA issued a draft revised guidance for industry, “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” in July 2016 that “described the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide [the agency] to address the human food safety of new animal drugs used in food-producing animals.”

In addition to proving that drugs are safe and efficacious in the targeted livestock species, drug companies (sponsors) face increasing hurdles to prove that “food derived from treated animals is safe for human consumption.”

FDA has already begun implementing other changes to “the way medically important antibiotics have been used in animal agriculture for decades.” See FDA’s Guidance #213.

As reported on its website, FDA explains:

“[o]nce the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.”

Food animal veterinarians and livestock farmers are concerned about their ability to treat animals with antibiotics appropriately when needed. In response,

“[t]he FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.”

In “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” FDA “provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

  • Determining an acceptable daily intake (ADI);
  • Calculating safe concentrations;
  • Assignment of a tolerance;
  • Calculation of a withdrawal period and a milk discard time; and
  • Evaluation of carcinogenic compounds.”

In addition to analyzing the appropriate withdrawal times for meat, milk, and eggs, the agency evaluates the proposed drugs for their potential to create additional pressures on antibiotic resistance in humans.

However, FDA has identified drugs that may not have to undergo this analysis if it (and its metabolites and excipients) are not:

  • “regularly considered to have properties that would exert pressure towards the emergence or selection of bacteria of public health concern;
  • used to treat zoonotic gastroenteritis or other bacterial diseases in humans;
  • under development to treat bacterial diseases in humans; or
  • indicated for a bacterial disease in food-producing animals (i.e., indication is instead antifungal, antiprotozoal, anthelminthic, etc.).”

With the emergence of new methods of disease treatment and  prevention (using, for example, genetically immune livestock) hopefully veterinarians and farmers will not have to rely on antibiotics to treat animals and keep them healthy, since it will be increasingly difficult to obtain and retain the ability to use these drugs in livestock.

 

While there is a dispute amongst attorneys about FDA’s authority to govern compounding in veterinary medicine in the absence of amendments to the Federal Food Drug and Cosmetic Act, there is no doubt that states may legislate or regulate this area of practice.

Compounding, defined by AVMA as “any manipulation of a drug beyond that stipulated on the drug label – is needed in veterinary medicine to provide individually mixed drugs for specific patients with special needs not met by FDA-approved drugs” remains an important tool for veterinarians, who must be vigilant in remaining in compliance with all relevant state and federal laws.

At least five states have recently introduced bills or regulations that limit or permit compounding by veterinarians for their patients in specified situations. “According to the American Veterinary Medical Association (AVMA), as of August 2015, nine states (including Virginia) have laws or regulations that permit licensed veterinarians to administer and dispense compounded products, in some cases under specified conditions.”

Maryland bill SB 614 “would provide an exception to state pharmacy law, specifying that it does not prohibit a licensed veterinarian from dispensing compounded preparations, provided by a pharmacy, for use in a companion animal, under specified circumstances. A pharmacy would be authorized to provide certain compounded preparations without a patient-specific prescription to a licensed veterinarian.”

Maryland defines “companion animal” as “a rabbit, bird, rodent, fish, reptile, amphibian, nonhuman primate, or any species of animal kept for pleasure rather than utility and accustomed to living in or about human habitation, or a cat or dog regardless of any utilitarian purpose. Companion animal does not include cattle, sheep, goats, swine, poultry, or any other animals kept for bona fide research or agricultural issues.”

Massachusetts HB 3989 would authorize a veterinarian to dispense a compounded drug, that is not prepared from bulk supplies, to the veterinarian’s patient under the following limited circumstances:

the animal is an animal companion; the quantity dispensed is no more than a 120 hour supply; the compounded drug is for the treatment of an emergency condition; and timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian.

The bill would also prohibit a veterinarian from selling or administering a compounded drug if it duplicated proprietary products or was a federally controlled substance.

In Colorado, HB 1324 would:

authorize a compounding pharmacy to compound and distribute a drug to a veterinarian without a specific patient indicated to receive the compounded drug; and a veterinarian to dispense a compounded drug, maintained as part of the veterinarian’s office stock, in an amount not to exceed 5 days’ worth of doses, if a patient has an emergency condition that the compounded drug is necessary to treat and the veterinarian cannot access, in a timely manner, the compounded drug through a compounding pharmacy.

Similar to the proposed Colorado bill, New York legislators are considering a bill that would permit veterinarians to inventory certain compounded drugs for use during emergencies and times that drugs would be available. Despite concerns about the safety of compounded drugs, the official justification for the bill stated:

Unlike human medicine, veterinary medicine has a unique service model. In many cases there is no ready alternative to a veterinarian having compounded medicines on hand at all times. This is especially true in emergency situations and at night and on weekends and holidays where there is no practical alternative but the animal hospital and its staff veterinarians for the purposes of filling a prescription for an animal with which a veterinary client patient relationship exists. The alternative to the safe and proper use of these safe substances would in many cases be suffering and possible death for the animal in need of them.

In Delaware, a proposed amendment to the Board of Pharmacy regulations would prohibit a pharmacist from selling “non-patient specific compounded products to a practitioner for office use unless covered under federal authority.” Unfortunately, this language does not provide much guidance to the regulated community.

“AVMA reports that compounding is critical for veterinary medicine because of the limited number of U.S. Food and Drug Administration-approved drug products for the many species and conditions that veterinarians treat.

Hopefully more states will permit the use of compounded drugs in veterinary practices so that practitioners can provide for the health of their patients.