Import Alert 68-20

Import Alert # 68-20

Published Date: 08/29/2023

Type: DWPE with Surveillance

DETENTION WITHOUT PHYSICAL EXAMINATION OF XYLAZINE ACTIVE PHARMACEUTICAL INGREDIENT (API) AND UNAPPROVED FINISHED DRUG PRODUCTS CONTAINING XYLAZINE

Xylazine (and xylazine hydrochloride) is a non-opioid agent that is the active ingredient in an animal drug which FDA originally approved in 1972 as a sedative and analgesic. It is used on many different animal species including dogs, cats, horses and Cervidae (certain species of deer and elk) to calm and facilitate handling, perform diagnostic and surgical procedures, relieve pain, or act as a local anesthetic.

Xylazine is not approved for use in humans. FDA is aware that xylazine is increasingly detected in the illicit drug supply and in human drug overdoses and deaths from such illicit drugs; however, individuals who use illicit drugs may not be aware of xylazine's presence in drugs that they are using. Xylazine has primarily been identified in combination with heroin and illicit forms of fentanyl. Xylazine has not been shown to be safe for use in humans and has resulted in serious and life-threatening side effects that appear to be similar to those commonly associated with opioid use, making it difficult to distinguish opioid overdoses from xylazine exposure. Therefore, in an effort to protect public health and safeguard against unsafe, non-veterinary use, FDA is issuing this import alert for drugs containing xylazine, both finished product and API, that are or appear to be adulterated or misbranded.

Under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), an API or bulk chemical that can be used as an API must have labeling that bears adequate directions for use, unless the API is subject to exemptions from labeling found in 21 CFR 201.122. A drug in a bulk package (except tablets, capsules, or other dosage unit forms) intended for processing, repacking, or use in the manufacture of another drug is exempt from the requirements of 502(f)(1) if certain conditions are met pursuant to 21 CFR 201.122. More specifically, if the API is intended for a use that causes the finished article to be a new animal drug, the API will be exempt from section 502(f)(1) if it bears certain required labeling and: (1) an approved application covers the production and delivery of the API to the application holder by persons named in the application; (2) delivery is made only to manufacture a new animal drug limited to investigational use as provided; or (3) a pending application covers the use of the API in the production of a finished drug product, and the finished drug product is not further distributed after it is manufactured until the application is approved.

Other uses for APIs include for pharmaceutical compounding by licensed pharmacists or veterinarians, or in registered outsourcing facilities.

Divisions may detain without physical examination shipments of xylazine bulk drug, xylazine API (including xylazine hydrochloride), and finished drug products containing xylazine identified in the Red List to this Import Alert.

Divisions may also detain shipments of xylazine bulk drug or xylazine API (including xylazine hydrochloride) that are, or appear to be, misbranded under section 502(f)(1). Given the public health importance, for any shipment of xylazine bulk drug or xylazine API (including xylazine hydrochloride) that is not on the Red List, contact CVM/Division of Drug Compliance at cvmimportrequests@fda.hhs.gov to determine whether the article meets one of the exemptions from labeling found in 21 CFR 201.120 or 201.122. CVM may advise as to what information or documentation to obtain to make this determination.

Divisions may also detain shipments of finished drug products containing xylazine that are, or appear to be, adulterated under section 501(a)(5). Given the public health importance, for any shipment of finished drug products containing xylazine that is not on the Red List, contact CVM/Division of Drug Compliance at cvmimportrequests@fda.hhs.gov to determine whether the article is approved or is subject to an INAD.

Recommendations for additions to the Red List of this import alert should be forwarded to the Division of Import Operations (DIO). DIO will coordinate with the Center for Veterinary Medicine (CVM) for concurrence.

Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

To request removal of an article from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues on policy or other additional technical questions should be addressed to Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance (CVM/OSC/DDC) at CVMImportRequests@fda.hhs.gov

                                                                                                                                                          

Xylazine Active Pharmaceutical Ingredients (APIs), xylazine hydrochloride, xylazine bulk drug, and unapproved xylazine finished product

Product Code: 60L[][]71

APIs: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranding, Section 502(f)(1)]

OASIS charge code: DIRSEXMPT

Unapproved Xylazine Finished Animal Drug Products: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. Unsafe new animal drugs are adulterated under Section 501(a)(5) of the Act. [Adulteration, Section 501(a)(5)]

OASIS charge code: NEW VET DR

Desc: XILAZINA 10% VETEC

Desc: XYLAZINE INJECTION 2%W/V (Xzin)

Desc: XYLAZINE INJECTION 2%

Desc: XYLAZINE INJECTION U.S.P. (XYLAXIN)