WARNING LETTER

Med Shop Total Care Inc. MARCS-CMS 581309 — July 30, 2019

Delivery Method:: VIA UPS
Product:: Animal & Veterinary

Recipient:: Recipient Name

Jennifer D. Yoakum; Recipient Title

Co-Owner and Pharmacist-in-Charge; Med Shop Total Care Inc.; 470 E. Loop 281
Longview, TX 75605-7939
United States

Issuing Office:: Office of Pharmaceutical Quality Operations, Division II; 4040 N. Central Expressway, Suite 300
Dallas, TX 75204
United States

July 30, 2019

Case # 581309

WARNING LETTER

VIA UPS EXPRESS

Jennifer D. Yoakum

Co-Owner and Pharmacist-in-Charge

Med Shop Total Care, Inc.

470 E. Loop 281

Longview, Texas 75605-7939

Mrs. Yoakum:

This letter concerns the animal drugs you produce from bulk drug substances at Med Shop Total Care, Inc. for food-producing animals, including but not limited to the following:

Estradiol

Progesterone-Estradiol

An Investigator from the U.S. Food and Drug Administration (FDA) inspected Med Shop Total Care, Inc. on October 15 – November 1, 2018. A Form FDA 483 was issued to you on November 1, 2018.

During the inspection, the investigator collected an Estradiol dispensing label which indicates that it was intended to be dispensed to (b)(4) for in use “breeding stock” and has a withdrawal time of 30 days. The investigator also collected a dispensing label for Progesterone-Estradiol for use in “breeding stock” intended to be dispensed to (b)(4). Your firm stated to the investigator that the medications were used in breeding heifers. In turn, the investigator expressed FDA’s concern related to your production of new animal drugs from bulk drug substances for use in food-producing animals. FDA considers heifers intended for breeding to be food-producing animals.

FDA acknowledges receipt of your facility’s response to the Form FDA 483, dated November 21, 2018. However, your response did not address FDA’s concerns related to your firm’s compounding for food-producing animals.

The animal drugs discussed above are labeled for use in treating breeder/breeding stock, food-producing animals, which makes them drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)]. In addition, your drug products are new animal drugs, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(c)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

The new animal drug products that you produce are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, or 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these drug products are unsafe under section 512(a) of the FD&C Act [21 U.S.C. § 360b(a)] and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction of an adulterated drug into interstate commerce is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. In addition, it is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

The FD&C Act does not generally distinguish between compounding and other methods for producing animal drugs. Animal drugs compounded from bulk drug substances must meet the FD&C Act’s requirements for approval under section 512, labeling with adequate directions for use under section 502(f)(1), and manufacturing under current good manufacturing practice (CGMP) under section 501(a)(2)(B). 21 CFR part 530 [21 U.S.C §§ 360b, 352(f), and 351(a)(2)(B)].

A limited exception from these requirements for animal drugs compounded from already approved animal or human drugs is provided by the extralabel use provisions of sections 512(a)(4) and (5) of the FD&C Act [21 U.S.C. §§ 360b(a)(4) and (5)] (AMDUCA), but this does not include compounding products from bulk drug substances. Compounding from approved, finished drugs is considered an extralabel use of approved drugs and is permitted so long as it complies with the conditions set out in the extralabel use provisions of the FD&C Act and FDA’s extralabel use regulations at 21 CFR part 530. Among other things, these regulations specify that nothing in the regulations should be construed as permitting compounding animal drugs from bulk drug substances. There are FDA-approved medications that may be legally used to control and synchronize estrous cycles in cattle. (Please see “The Cattle Estrous Cycle and FDA-Approved Animal Drugs to Control and Synchronize Estrus – A Guide for Producers” and Animal Drugs @ FDA for specific information about each drug.)

FDA is particularly concerned about potential public health risks associated with your production and distribution of unapproved animal drugs for use in food-producing animals. The use of unapproved animal drug products in food-producing animals could result in drug residues in the edible tissues of these animals that may present a food safety concern for humans. As part of the approval process for a finished drug product intended for use in food-producing animals, FDA reviews data regarding the potential for harmful residues and bases tolerances and withdrawal times on these data. The products you compound from bulk drug substances have not undergone a similar review.

This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.^{^[1]} You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the violations set forth above and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. If you believe that this product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your written notification should refer to the Warning Letter Number above (Case # 581309). Please electronically submit your signed reply on your firm’s letterhead to CDR John W. Diehl, M.S., Director, Compliance Branch, at john.diehl@fda.hhs.gov and orapharm2_responses@fda.hhs.gov.

If you have questions regarding the contents of this letter, you may contact Mr. Thao Ta, Compliance Officer, via phone at 214-253-5217 or e-mail at thao.ta@fda.hhs.gov.

Sincerely,

/S/

Monica R. Maxwell

Program Division Director

Office of Pharmaceutical Quality Operations,

Division II

cc:

Dee D. Hollis

Co-Owner and Manager

Med Shop Total Care, Inc.

470 E. Loop 281

Longview, Texas 75605-7939

[1] This letter addresses only your firm's animal drug products for food-producing animals. FDA may communicate with you separately about your drugs for human use.