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FDA Warning Letter Explorer
Drugs · Aug 2, 2021

Pharmaceutical Care Solutions dba Pharmacy Solutions

4 extracted findings

FDA source excerpt, selected passage

Your firm compounded drug products using ammonium tetrathiomolybdate. Drug products compounded using ammonium tetrathiomolybdate are not eligible for the exemptions provided by section 503A(a), because ammonium tetrathiomolybdate is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug and does not appear on the 503A bulks list.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
Your firm compounded drug products using ammonium tetrathiomolybdate. Drug products compounded using ammonium tetrathiomolybdate are not eligible for the exemptions provided by section 503A(a), because ammonium tetrathiomolybdate is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug and does not appear on the 503A bulks list.
02
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.
03
The ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses.
04
Tranilast was nominated for inclusion on the 503A bulks list, was evaluated by Pharmacy Compounding Advisory Committee and by FDA and FDA determined not to include tranilast on the list of bulk drug substances that can be used in compounding under section 503A, found at 21 C.F.R. 216.23(a). See 21 C.F.R. 216.23(b)(4). Accordingly, drug products compounded using tranilast are not eligible for the exemptions provided by section 503A(a).

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 216.23(a)21 CFR 216.23(b)(4)21 CFR 201.115

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