Pharmaceutical Care Solutions dba Pharmacy Solutions
FDA issued a warning letter to Pharmaceutical Care Solutions dba Pharmacy Solutions (Ann Arbor, MI) following a January 2020 inspection, finding that the compounding pharmacy produced drug products ineligible for section 503A exemptions by using ammonium tetrathiomolybdate — a bulk drug substance not on the 503A bulks list, not USP/NF monograph-compliant, and not a component of an FDA-approved drug — and by sourcing bulk drug substances from an unregistered manufacturer. As a result, the compounded products were deemed unapproved new drugs and misbranded under the FDCA. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Your firm compounded drug products using a bulk drug substance manufactured by (b)(4), which is not a registered establishment under section 510 of the FDCA.
Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
Your firm compounded drug products using ammonium tetrathiomolybdate.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.
you have not agreed to cease compounding with ammonium tetrathiomolybdate.
Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker