ElectRx and Health Solutions, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

These products are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions that do not apply here, new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No FDA-approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].

Passage 2

A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). The drugs offered by ElectRx are prescription drugs intended to treat conditions that are not amenable to self-diagnosis and treatment by persons who are not medical practitioners. Therefore, adequate directions for use cannot be written for these drugs, and they must qualify for one of the exemptions to section 502(f)(1) to avoid being misbranded. The exemption to section 502(f)(1) found at 21 CFR § 201.100 does not apply to unapproved new drugs because that exemption requires that such drugs bear “the labeling authorized by the approved new drug application.” In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. Because none of the exemptions to section 502(f)(1) apply, these drugs are misbranded under section 502(f)(1).