# FDA WARNING_LETTER - Northwest Pharmacy - June 28, 2012

Source: https://www.keypedia.com/records/warning_letter/northwest-pharmacy/c999d474-5f62-4e10-bf00-376c0cc89f10

> FDA WARNING_LETTER for Northwest Pharmacy on June 28, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Northwest Pharmacy
- Inspection Date: 2012-06-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 4, 2012, the FDA reviewed www.NorthWestPharmacy.com and found it offered unapproved and misbranded new drugs for sale, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, Alitretinoin (Toctino) was offered to treat severe hand eczema.

Toctino is considered a "drug" and "new drug" under sections 201(g) and 201(p) of the FD&C Act, as it's intended for disease treatment and is not generally recognized as safe and effective for its labeled use. Despite Canadian approval, no FDA application under section 505 is in effect, making its interstate commerce a violation of section 505(a) and prohibited under section 301(d).

Furthermore, Toctino is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use. Alitretinoin is teratogenic, requiring strict safety controls in Canada (physician oversight, pregnancy tests). Online sales to U.S. consumers bypass these controls, posing significant risks.

The FDA emphasized the inherent risks of unapproved and misbranded drugs, which may lack safety, efficacy, and quality assurances, potentially being contaminated, counterfeit, or containing incorrect ingredients. FDA-regulated drugs undergo rigorous approval, labeling, and manufacturing oversight.

NorthWest Pharmacy was

## Related Officers

- [Office Director](https://www.keypedia.com/people/thomas-tj-christl/64bd97de-4180-46e9-a1a9-9b1230abaf24)

Company: https://www.keypedia.com/companies/northwest-pharmacy/c4ee41c1-6bb1-4a4a-b0ba-1e2202639f0e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c