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# Edge Pharma Illegally Marketing Allergenic Extracts: FDA
- URL: https://www.fdaweb.com/edge-pharma-illegally-marketing-allergenic-extracts-fda/
- Published: 2021-01-26T12:00:00.000Z
- Updated: 2026-09-14T16:44:06.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5148528

FDA says Edge Pharma, Colchester, VT, is marketing mixtures of allergenic extracts for patient-specific allergy treatment, including some intended for sublingual immunotherapy. A 1/22 [Notice of Violation](https://www.fda.gov/media/145431/download?ref=fdaweb.com) says the firm’s patient-specific extracts and custom mix allergy immunotherapy vials that are not patient-specific can only be lawfully marketed under an approved BLA. “Your products are not the subject of an approved BLA nor is there an IND in effect for any of your products,” the letter says. “Therefore the marketing and distribution of such products appears to violate the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.”

The letter also points out that although the firm’s Web site refers to it as a registered 503B outsourcing facility, biological products subject to licensure under section 351 of the Public Health Service Act are not eligible for exemptions for compounded drugs under the Federal Food, Drug, and Cosmetic Act.

Edge was told to respond within 30 days.