Benzoyl Peroxide

The US Food and Drug Administration (FDA) published the FY2027 OTC Monograph Drug User Fee (OMUFA) rates on 29 July 2026: USD 47,891 for monograph drug facilities (MDF) and USD 31,927 for contract manufacturing organisations (CMO), about 149% higher than in FY2026 (FY2026 was an unusually low point following a one-off statutory reserve adjustment). The payment date moves from June to October, with two equal instalments due on 1 October 2026 and 1 February 2027.

What to do: Contract manufacturers producing OTC monograph drugs for US brands (e.g. acne products containing salicylic acid or benzoyl peroxide, and sunscreens) must pay the official CMO fee of USD 31,927, with the first half (USD 15,963.50) due on 1 October 2026. The fee should be factored into the cost of US OTC business. Non-OTC product lines are not affected.

Source: FDA OMUFA

Under RDC 1.030/2026 of Brazil's National Health Surveillance Agency (ANVISA), newly prohibited substances include boric acid and borates, ketoconazole, and Polyurethane-18 and Polyurethane-19. The deadline for reformulating fragrances containing Lilial and Lyral is extended to 11 December 2027. Benzoyl peroxide, hydroquinone and azelaic acid are reclassified from prohibited to restricted.

What to do: Brands and manufacturers of acne-care products may wish to consider the opportunity created by the reclassification of benzoyl peroxide and azelaic acid; the specific concentration limits remain to be confirmed.

Source: ANVISA RDC 1.030/2026