FDA WARNING_LETTER - buy-pharma.com - January 08, 2022

The FDA issued a Warning Letter to www.buy-pharma.com after reviewing its website on January 8, determining it offers products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the firm is marketing Pirfenidone (brand name Pirfenex), an unapproved new drug, and a misbranded drug to U.S. consumers. Pirfenidone is considered a drug intended for idiopathic pulmonary fibrosis, but lacks an approved application under section 505 of the FD&C Act, making its introduction into interstate commerce a violation of section 505(a) and a prohibited act under 301(d). Furthermore, the drug is misbranded under section 502(f)(1) because its labeling fails to bear adequate directions for use, as it's intended for conditions not amenable to self-diagnosis and treatment by laypersons. The introduction of this misbranded drug into interstate commerce is a prohibited act under section 301(a). The FDA emphasizes the inherent risks of unapproved and misbranded drugs, including concerns about safety, efficacy, quality, contamination, and counterfeiting, as they lack the rigorous oversight of FDA-regulated products. The firm is required to immediately cease marketing these violative drug products and notify the FDA in writing within 15 working days of the steps taken to correct the violations and prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.