WARNING LETTER

Meds For Vets, LLC MARCS-CMS 714361 — August 15, 2025

Product:: Animal & Veterinary
Drugs

Recipient:: Recipient Name

Janice L. Erickson; Recipient Title

Owner; Meds For Vets, LLC; 9550 S State St
Sandy, UT 84070-3211
United States; (b)(6), (b)(7)(C)

Issuing Office:: Center for Veterinary Medicine; United States

August 15, 2025

WARNING LETTER

Re: Case 714361

Dear Ms. Erickson:

The U.S. Food and Drug Administration (FDA) inspected your facility, Meds For Vets, located at 9550 S State St, Sandy, UT 84070-3211, from February 11, 2025, through February 21, 2025. During the inspection, the inspection team noted deficiencies in your practices for producing animal drugs and issued Form FDA 483. The inspection team also discussed the circumstances under which you produce animal drugs from bulk drug substances and distribute them, including drugs for food-producing animals, copies of FDA-approved products, and office stock compounded without patient-specific prescriptions. You responded to the inspection in writing on March 27, 2025 and April 14, 2025. We have reviewed your responses and discuss them in the relevant parts of this letter.

For the reasons set forth below, you produce and distribute adulterated and misbranded animal drugs in violation of sections 301(a) and 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A. Unapproved New Animal Drugs
You compound drugs for animals from bulk drug substances (BDS). From December 16, 2024 to February 10, 2025, you filled approximately (b)(4) prescriptions or orders for animal drugs. Most of your products are compounded using BDS.¹

Animal drugs compounded from BDS are new animal drugs as defined in section 201(v) of the FD&C Act because they are not generally recognized as safe and effective by experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs. Under section 512 of the FD&C Act, to be legally distributed, a new animal drug requires an approved new animal drug application, conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Compounded drugs do not go through any of these pre-market review processes. Although compounded human drugs are, under certain circumstances, exempt from the human drug approval requirement in section 505 of the FD&C Act, no comparable exemption from section 512 exists for animal drugs. As a result, your compounded drugs are unsafe under section 512(a) of the FD&C Act and adulterated under section 501(a)(5) of the FD&C Act. Distribution of adulterated animal drugs violates the FD&C Act.

In addition, the drug products you compound from BDS are intended for conditions not amenable to diagnosis and treatment by individuals who are not veterinarians. Therefore, adequate directions for use cannot be written so that a lay person can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses as required under section 502(f)(1) of the FD&C Act, and as they are not exempt from this requirement by any other statutory provision or regulation, they are misbranded. Distribution of misbranded animal drugs violates the FD&C Act.

Although compounded animal drugs lack required approval or index listing, FDA acknowledges there are some situations in which no FDA-approved or indexed drug can treat an animal, and a drug compounded from BDS may be medically appropriate. FDA’s Guidance for Industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances” identifies the circumstances under which FDA does not intend to take enforcement action against drugs compounded from BDS. The guidance also generally describes our enforcement priorities with respect to compounded animal drugs. Our priorities for enforcement include animal drugs that are intended for use in food-producing animals; copies of marketed FDA-approved or indexed drugs; or drugs compounded without a patient-specific prescription (i.e., office stock).

Drugs for Food-producing Animals

Use of drugs compounded from BDS to treat food-producing animals and free-ranging wildlife species risks exposing humans to harmful residues in the animals’ edible tissues because these drugs have not been reviewed to determine human food safety. According to your product labels, compounding log, and prescriptions, you compound products for use in food-producing animals, for example:

Rx (b)(6) - Meloxicam 5 mg/mL Suspension Chicken AQ for a chicken
Rx (b)(6) - Gabapentin 100 mg/mL Suspension No Flavor for a duck
Rx (b)(6) - Enrofloxacin 20 mg/mL Suspension Banana Oil for a rabbit

Your records do not include any documentation asserting that these animals are not food-producing (i.e., are not used for meat, milk, or eggs). Additionally, your records do not contain information regarding the animals’ life circumstances or use that would support a conclusion they are not food-producing. We acknowledge your post-inspection written response where you created a new procedure, SOP-PP-01 “Prescription Intake and Review for Compounded Animal Drugs,” which states that prescriptions for food-producing animals must include a withdrawal time and that non-food producing animals must be labeled as “not for food” or “pet”. However, it is unclear how you intend to determine whether an animal is a pet and/or not for food and what information you intend to document to support these conclusions.

Additionally, your prescription log includes prescriptions for “Other Aves”, instead of a species. (Aves is a taxonomic class that encompasses all birds). Documenting the animal species is critical for animal health because appropriate dosing can vary between species and is critical for human health to ensure that compounded animal drugs are not intended for use in a food-producing species. “Other Aves” could encompass food producing animals, such as chickens and turkeys.

Copies of Approved or Indexed Products

FDA considers an animal drug compounded from a bulk drug substance to be a copy of an FDA-approved or indexed product if it has the same active ingredient or active moiety and is given by the same route of administration (“ROA”). In addition, FDA considers a combination drug product to be a copy if any of its active ingredients are approved in the same ROA. Compounded copies of approved or indexed animal drugs are an FDA priority for enforcement because they may expose animals to drugs produced under lesser quality controls compared to the approved/indexed products and reduce incentives for firms to seek approval or indexing of their drugs. The following examples are representative of your firm’s practice of compounding copies of approved products:

Rx (b)(6) - Pergolide Mesylate 1 mg capsules for a horse
o Your pergolide mesylate capsules (oral ROA) are a copy of the 1 mg pergolide tablets FDA-approved for use in horses (NADA 141331). Your records state, “Per Clinic this drug would make a clinical difference for this patient because it is not available in dosage…Strength”. This statement is false. Pergolide mesylate is available in this dosage/strength (1 mg tablets, NADA 141331).
Rx (b)(6) - Trilostane 20 mg Capsules for a dog
o Your trilostane capsules (oral ROA) are a copy of the 5, 10, 20, 30, 60, and 120 mg trilostane capsules FDA-approved for use in dogs (NADA 141291). Your records state, “Per Clinic this drug would make a clinical difference for this patient because it is not available in dosage...Strength…Form”. This statement is false; trilostane is available in this dosage form and strength (20 mg capsules, NADA 141291).
Rx (b)(6) - Fluoxetine HCl 30mg Capsules for a dog
o Your trilostane capsules (oral ROA) are a copy of the fluoxetine chewable tablets FDA-approved for use in dogs (NADA 141272) and the fluoxetine oral dosage forms FDA-approved for use in humans. A medical rationale describing the clinical difference was not documented in your records for this prescription.

We acknowledge that, in response to our inspection, you created SOP-PP-01 “Prescription Intake and Review for Compounded Animal Drugs” which states that a “justification must be provided if compounding is a commercially available product and it must be documented in the patient file or as a note on the prescription (e.g., allergy, unavailable strength/form).” We remind you that FDA’s enforcement discretion policy in GFI #256 covers circumstances where there is a difference between the compounded drug and the FDA-approved or indexed drug such that it will produce a clinical difference in the identified patient as determined by the treating veterinarian and the guidance recommends how this clinical difference should be documented (see GFI #256 Section A. Compounding for Nonfood-Producing Animals: Patient-Specific Prescriptions and Q&A: GFI #256 - Compounding Animal Drugs from Bulk Drug Substances). The example justification in your SOP, “unavailable strength/form”, does not describe a clinical difference in a patient because it does not address whether the approved product could be used for the same dosage or route of administration. For example, a dosage of 20 mg could be achieved with two 10 mg capsules.

When using a compounded drug that will make a clinical difference in the identified patient, it may be possible to legally compound by modifying an approved product (i.e., use an approved product as the source of active ingredients) rather than illegally compound by starting from BDS.² For example, with respect to the copies discussed above:

Rx (b)(6) - Pergolide Mesylate 1 mg Capsules for a horse
o You did not document why the FDA-approved pergolide drug cannot be used as the source of the active ingredient for compounding.
Rx (b)(6) - Trilostane 20 mg Capsules for a dog
o You did not document why the FDA-approved trilostane drug cannot be used as the source of the active ingredient for compounding.
Rx (b)(6) - Fluoxetine HCl 30mg Capsules for a dog
o You did not document why the FDA-approved fluoxetine drugs cannot be used as the source of the active ingredient for compounding.

We acknowledge that you stated that you intend to include the rationale for compounding from BDS in your compounding formula worksheets and that this will be completed on a case-by-case basis. You provided updated compounding formula worksheets for five drugs, and these contain the compounding rationale. However, it does not appear that you have considered all of the FDA-approved formulations that could be used as the source of the active ingredient for compounding. For example, the compounding formula worksheet provided for Cyclosporine 1% ((b)(4) oil) Eye Drops includes the following compounding rationale, “BULK CYCLOSPORINE IS USED INSTEAD OF COMMERCIALLY AVAILABLE PRODUCT DUE TO FILLERS/EXCIPIENTS BEING UNSAFE AND NOT RECOMMENDED FOR STERILE EYE DROPS”. Cyclosporine is FDA-approved in various sterile ophthalmic dosage forms, so it is unclear from your rationale why these FDA-approved ophthalmic dosage forms could not be used as the source of the active ingredient for compounding an ophthalmic drug. Your records do not specify what fillers or excipients in which FDA-approved products are unsafe or the basis for concluding each FDA-approved product contains fillers/excipients that are unsafe to use.

Office Stock

“Office stock” refers to compounded drugs ordered by a veterinarian without a patient-specific prescription to keep on hand in the veterinary clinic or office to administer or dispense to patients. When drugs are compounded for use as office stock, and are therefore readily available for use, the products potentially expose large numbers of animals to drugs of unproven safety, effectiveness, and quality. You stated that you do not compound drugs for office stock. However, you compounded prescriptions where the volume of drugs dispensed and/or associated records show the prescriptions are more than likely intended for use in more than the identified patient. The following examples are representative of your firm’s practice of compounding drugs intended for use in more than the identified patient:

Rx (b)(6) - Clomipramine HCl 10mg/mL Suspension Chicken Oil, (b)(4) mL for cats filled on (b)(4)
o In the patient name field, the prescription label shows “FOR OFFICE USE ONLY”, indicating that this is not a patient-specific prescription, but is intended for use as office stock.
Rx (b)(6) - Phenylbutazone 1g/scoop Cherry-Apple Powder ((b)(4) grams total) for a horse filled on (b)(4)
o The quantity of this prescription indicates that it is for more than one horse. The directions are to give by mouth as directed. Considering the labeling for the relevant FDA-approved drugs for horses containing phenylbutazone (which state not to exceed 4 g daily), as well as considering other medically-recognized uses, the largest medically-reasonable dosing regimen should not exceed an average of 4 g daily. Assuming a 4 g daily dose, this prescription would provide (b)(4) days of treatment. The beyond use date for this prescription is 7/28/2025 ((b)(4) days from the date filled). If this prescription was intended to be used only in the identified horse patient, treatment would be expected to exceed the beyond use date of this drug. We note that this prescription is written for a horse that belongs to the prescribing veterinarian, further supporting the conclusion it is intended as office stock.
Rx (b)(6) - Pimobendan 5mg/mL Suspension Chicken AQ ((b)(4) mL total) for a dog filled on (b)(4)
o In the patient name field, the prescription label states “DOG IN EXAM ROOM (b)(4)”. An exam room does not adequately identify the patient because many dogs use the same exam room, indicating that this is not a patient-specific prescription, but is intended for use as office stock.
o The quantity of this prescription indicates that it is for more than one dog. The beyond use date for this drug is 2/3/2025 and a total of (b)(4) mL ((b)(4) mg) was dispensed. For comparison, the largest dose of pimobendan based on the FDA-approved drugs’ labeling would be 0.5 mg/kg, which is enough to treat more than one large dog or many average or smaller dogs. Considering other medically-recognized uses, the largest medically-reasonable dosing regimen would be 0.9 mg/kg/day, which is also more than needed to treat one large dog and enough to treat many average or smaller dogs. If this prescription was only intended to be used in one dog, treatment would be expected to exceed the beyond use date of this drug.

We acknowledge that your response dated April 14, 2025, states that “The Pharmacy is reviewing and updating its applicable prescription fulfilment SOP to retrain all staff members and reiterate the fact that the pharmacy does not fill office stock.” You also provided SOP-PP-01 “Prescription Intake and Review for Compounded Animal Drugs”, which states that “This procedure does not apply to Office stock, except where permitted by GFI #256 for non-food producing animals.” Based on these inconsistent responses, it is unclear if your firm intends to compound office stock for non-food producing animals based on the recommendations in GFI #256 and, if yes, the specific procedures you intend to use for office stock. Furthermore, it is unclear from your SOP how your firm determines whether or not a prescription is intended for use as office stock.

B. Drug Quality Violations

Current Good Manufacturing Practice Violations

All animal drugs produced from bulk drug substances are subject to the FD&C Act’s Current Good Manufacturing Practice (CGMP) requirement, section 501(a)(2)(B), and our inspection determined that you are not in compliance with that requirement. We noted that your firm sells office stock, which potentially exposes large numbers of animals to drugs which do not meet the CGMP quality standard set by the FD&C Act, but does not perform stability testing to ensure the drug retains the appropriate potency, purity, and quality while being stored awaiting a patient.³ We further noted that your firm produces copies of FDA-approved products from bulk drug substances but does so without the same CGMP controls which ensure their quality. For example, unlike FDA-approved products, you fail to test the strength/potency⁴ and establish, follow, and validate all aseptic and sterilization processes to prevent microbial contamination.⁵

You use inadequately cleaned equipment to produce sterile drugs, which you fill into (b)(4), inadequately sterilized vials, and subject finished drug products to a unvalidated aseptic filling and sterilization process(s), including the use of non-pharmaceutical grade household equipment as follows:

- You clean glassware used to mix non-sterile bulk drugs for the production of sterile drugs using household detergent not intended for use in drug production (e.g., (b)(4)) in an automatic dishwasher, store them unwrapped in an unclassified area, and do not (b)(4) or sterilize them.⁶ Inadequately cleaned glassware can introduce contaminants including pyrogens directly into the drug product.

- You purchase non-sterile/(b)(4) finished product vials. You do not (b)(4) them, and you attempt to sterilize them without a documented or validated process (no defined load pattern, sterilization cycle, or sterilization process).⁷ Additionally, we observed vials stored uncovered in the ISO7 room, exposed to the environment.⁸ Inadequately sterilized and (b)(4) glassware can introduce contaminants directly into the finished drug product.

- For drugs you attempt to render sterile via (b)(4), you use an uncalibrated air pressure gauge for post (b)(4).⁹ An uncalibrated air pressure gauge does not allow accurate assessment of whether the sterilizing (b)(4) was defective or failed during the sterilization process. Furthermore, your aseptic filling process has not been adequately validated because you did not conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions because your media fills used significantly fewer units and smaller vials than your largest batch size.¹⁰ Media fills that represent actual, worst-case conditions are critical because they demonstrate whether your operators, environment, and process are capable of consistently producing sterile drugs. As it is impossible to test each individual unit for sterility, media fills, where operators produce entire batches under worst-case conditions and examine every unit for contamination, are critical to demonstrate operators, environment, and processes are capable of consistently producing sterile drugs.

- You used non-sterile cleaning pads to clean surfaces in the ISO5 area, and we observed those pads stored open in the ISO7 and ISO8 areas.¹¹ This practice risks bringing contamination into the ISO5 area where drug and product-contact surfaces are exposed.

- For the drug products you attempt to render sterile via (b)(4), you do not have a defined or validated (b)(4) for each product.¹² An unvalidated sterilization process can either leave viable microorganisms in the drug (rendering it nonsterile) or can degrade the active ingredient(s), resulting in subpotent drug.

- For the non-hazardous drug products you attempt to render sterile via (b)(4), you use a household countertop toaster oven intended for cooking food ((b)(4), Model (b)(4)), without a defined time and temperature for each specific product, and without measuring the actual temperature.¹³ An uncontrolled process such as this can leave viable microorganisms in the drug (rendering it nonsterile) and/or can degrade the active ingredient(s), resulting in subpotent drug.

- Your smoke studies were inadequately performed under dynamic conditions. These studies are critical for verifying proper airflow patterns and identifying possible contamination risks caused by the movement of operators during filling.

We acknowledge you made numerous commitments to improve your operations. Many remain in-progress, and the supporting documentation you provided thus far is not enough for us to evaluate the overall effectiveness of your changes.

Conclusion

All of the animal drugs you produce from BDS violate the FD&C Act’s requirements for approval/indexing, adequate directions for use, and CGMP.¹⁴ We do not consider you a low priority for enforcement action as described in GFI #256. The specific drugs identified above are examples that represent general practices at your firm. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all the requirements of federal law, including FDA regulations.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please direct your response to CVMCompounding@fda.hhs.gov and include “Reference Case: 714361 in the subject line of your email. If you have questions regarding the contents of this letter, please contact CVMCompounding@fda.hhs.gov.

Sincerely,
/S/

Brett R. Havranek, J.D.
Acting Division Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food & Drug Administration

_____________________

1 The FD&C Act permits the compounding of animal drugs made from FDA-approved animal or human drugs, provided the conditions for legal extralabel use described in the FD&C Act and FDA’s extralabel use regulations are met. Sections 512(a)(4) and (5) of the FD&C Act [21 U.S.C. § 360b(a)(4) and (5)] and 21 CFR part 530. FDA’s regulations on extralabel use do not permit compounding from BDS. 21 CFR 530.13(a).

2 See 21 CFR 530.13.

3 See 21 CFR 211.166(a).

4 See 21 CFR 211.165(a).

5 See 21 CFR 211.113(b) and FD&C Act section 501(a)(2)(A).

6 See 21 CFR 211.67 and FD&C Act section 501(a)(2)(A).

7 See 21 CFR 211.94.

8 See 21 CFR 211.80(b) and section 501(a)(2)(A).

9 See 21 CFR 211.160(b)(4).

10 See 21 CFR 211.113(b) and FD&C Act section 501(a)(2)(A).

11 See 21 CFR 211.42(c)(10)(v) and FD&C Act section 501(a)(2)(A).

12 See 21 CFR 211.113(b).

13 See 21 CFR 211.63, 211.113(b) and FD&C Act section 501(a)(2)(A).

14 Section 512 of the FD&C Act [21 U.S.C. § 360b], 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1), and section 501(a)(2)(B) of the FD&C Act [21 U.S.C. § 351(a)(2)(B)] (See also, 21 CFR parts 210 and 211.)