FDA WARNING_LETTER - pharmaceutical care solutions - January 24, 2020

On August 2, 2021, the FDA issued a Warning Letter to Pharmaceutical Care Solutions dba Pharmacy Solutions following an inspection from January 15-24, 2020. The inspection revealed the firm produced drug products that failed to meet the conditions for exemption under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), rendering them unapproved new drugs and misbranded.

Violations include compounding drug products using ammonium tetrathiomolybdate, which is not on the 503A bulks list, is not a component of an FDA-approved drug, and lacks a USP/NF monograph. Additionally, the firm used bulk drug substances manufactured by an unregistered establishment ((b)(4)) under Section 510 of the FDCA. These actions mean the compounded drugs are not exempt from FDA approval (Section 505), adequate labeling requirements (Section 502(f)(1)), and current good manufacturing practice (CGMP) regulations (Section 501(a)(2)(B)).

The firm's February 14, 2020, response was deemed deficient as it did not agree to cease compounding with ammonium tetrathiomolybdate and failed to address the use of substances from unregistered establishments. The FDA noted that ammonium tetrathiomolybdate's nomination for the 503A bulks list was withdrawn, and tranilast