BPI Labs, LLC

This letter concerns your firm’s, BPI Labs, LLC’s (BPI’s), distribution of its Epinephrine Chloride Nasal Solution 1 mg/mL, 10 mL. The U.S. Food and Drug Administration (FDA) reviewed your product, including product labeling.

Your Epinephrine Chloride Nasal Solution product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

This product is also misbranded under section 502(i) of the FD&C Act, 21 U.S.C. 352(i). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

Epinephrine Chloride Nasal Solution is a drug within the meaning of section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body of man or other animals. Specifically, this product is intended for use as a nasal decongestant/vasoconstrictor. Examples of claims observed on BPI’s Epinephrine Chloride Nasal Solution labeling, including the product label, that provide evidence of its intended use (as defined in 21 C.F.R. 201.128) include, but may not be limited to, the following:

“Vasoconstrictor for Topical Application”

“For use as a nasal decongestant”

In general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an application approved by FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a).

FDA is not aware of any adequate and well-controlled clinical trials in published literature that support a determination that Epinephrine Chloride Nasal Solution is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which the product would be legally marketed without an approved application. Further, no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). The introduction or delivery for introduction of unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1), provides that a drug is misbranded if “its container is so made, formed, or filled as to be misleading . . .” BPI’s unapproved Epinephrine Chloride Nasal Solution product is labeled for use as a topical nasal decongestant, to be “[a]ppl[ied] locally as drops or spray, or with a sterile swab, as required.” Notwithstanding its intended use as a topical drug, the container closure system for BPI’s unapproved epinephrine nasal solution appears identical to that used for BPI’s FDA-approved epinephrine injection product, which is a small glass vial with a flip-off cap that protects a needle penetrable seal. This type of glass vial is a container closure that is customarily used by drug manufacturers to package small volumes (e.g., 10 or 20 mL) of sterile injectable drugs intended for parenteral administration (including intravenous administration). The Epinephrine Chloride Nasal Solution glass vial and its similarity to the glass vials for your FDA-approved Epinephrine Injection may mislead users into believing the product is intended for injection and thereby, increase the risk of erroneous administration. FDA has received reports of confusion between your firm’s unapproved Epinephrine Chloride Nasal Solution and FDA-approved Epinephrine Injection resulting in the erroneous preparation of your unapproved nasal product for parenteral administration.1 As such, your unapproved Epinephrine Chloride Nasal Solution product, packaged in a container that appears identical to containers ordinarily used to package sterile injectable drugs, is a misbranded drug under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).

The introduction or delivery for introduction into interstate commerce of a misbranded drug violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

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 requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, 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 no longer manufacture or market the above-mentioned product, your response should indicate this, including the reasons that, and the date on which, you ceased production. Also, please indicate your progress in updating the drug listing eDRLS files in accordance with 21 C.F.R. 207.57(b). If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot address any violations within fifteen working days, state the reason for the delay and the time within which you will do so.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “699533” in the subject line of the email.