21 U.S.C. § 353a–1 — Enhanced communication

This section builds a two-way information channel between the FDA and state pharmacy boards about compounding pharmacies. (a) Submissions from State boards of pharmacy. The Secretary of Health and Human Services must accept reports from state boards of pharmacy that either describe an action taken against a compounding pharmacy (defined in (b) below), or raise a concern that a compounding pharmacy may be violating section 353a of this title. (b) Content of submissions from State boards of pharmacy. The actions state boards can report are: issuing a warning letter or imposing sanctions or penalties for violating a state's compounding rules; suspending or revoking a pharmacy's state license or registration for violating those rules; or recalling a compounded drug over concerns about its quality or purity. (c) Consultation. The Secretary must carry out subsection (a) in consultation with the National Association of Boards of Pharmacy. (d) Notifying State boards of pharmacy. The Secretary must immediately notify state pharmacy boards whenever the Secretary receives a report described in subsection (a)(1), or determines on its own that a pharmacy is acting contrary to section 353a.