Royer Animal Health, LLC 1/13/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215-3215 Telephone: (410) 779-5454

FEI: 3007481380

WARNING LETTER
VLN#75886

January 13, 2010

FedEx

Garfield P. Royer, Ph.D.
President
Royer Animal Health, LLC
4580-E Mack Avenue
Frederick, Maryland 21703

Dear Dr. Royer:


This letter concerns violations of the Federal Food, Drug, and Cosmetic Act (the Act) with respect to the distribution of ''R-Gel™ Antibiotic Wound Dressing" (R-Gel) for use in horses, dogs, and cats. Our review of your product's label and the Royer Animal Health (RAH) web site, www.royerah.com. reveals that your R-Gel product is adulterated under section 501 (a)(5) of the Act [21 U.S.C. § 351 (a)(5)] because it is an unapproved new animal drug that is unsafe within the meaning of section 512 of the Act [21 U.S.C. § 360(b)]. In addition, R-Gel is misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)] because your firm has failed to register and list as required by section 510 of the Act [21 U.S.C. § 360].

Unapproved New Animal Drug:

Statements made on your product's label and your firm's web site at the internet address www.royerah.com establish that R-Gel is a drug within the meaning of section 201 (g) of the Act [21 U.S.C. § 321 (g)]. Section 201(g) of the Act [21 U.S.C. § 321(g)] defines "drug," in part, as an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and articles (other than food) intended to affect the structure or any function of the body.

Some examples of statements on the product label and the RAH web site that establishes these intended uses for your product include, but are not limited to, the following:

• Proven effective against numerous localized infections
• Contains Amikacin and Clindamycin to treat traumatic wounds and local infections where supraphysiologic doses of antibiotics are desired
• Timed Release of Antibiotics
 

In addition, R-Gel is a "new animal drug" under section 201(v) of the Act [21 U.S.C. § 321 (v)], because it is 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 the above referenced uses.

Because this drug is not the subject of an approved new animal drug application (NADA), as required by section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)], R-Gel is unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and thus adulterated under section 501 (a)(5) of the Act, [21 U.S.C. § 351 (a)(5)]. Section 301(a) of the Act, [21 U.S.C. § 331 (a)] prohibits the introduction of adulterated or misbranded drugs into interstate commerce. Your distribution of R-Gel without an approved application is in violation of the law.

Registration and Listing:

In addition to the violations noted above, we are aware that you have not registered your establishment nor provided a list of drugs being manufactured for commercial distribution. Under section 510 of the Act [21 U.S.C. §360], every person who owns or operates any establishment engaged in the manufacture, preparation, or processing of a drug is required to register with the FDA and provide a list of the products it distributes. Because your firm is not registered and you have not provided FDA with a list of products you distribute, including R-Gel, RAH has not complied with sections 510(b)(1), (c) and Q) of the Act, [21 U.S.C. § 360(b)(1), (c), and U)]. Products manufactured by a firm that has not registered and products not listed in accordance with section 510 are considered misbranded under section 502(o) of the Act [21 U.S.C. §352(o)]. Therefore, R-Gel is misbranded and RAH's distribution of it violates the Act.

The issues and violations mentioned above are not intended to be an all-inclusive list of violations that exist with respect to your distribution of new animal drugs. You are responsible for investigating and for preventing recurrence of these, or other violations, to ensure that you comply with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations described in this letter. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating the corrections you have made.

Your reply should be directed to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5454, extension 417.

Sincerely yours,

/S/
Evelyn Bonnin
District Director
Baltimore District Office
 

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