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Scientific Solutions Global's Formulations Miss OTC Monographs Mark – FDA

 
• By Malcolm Spicer

Firms' BioTemper, bare and Urea brand products, as formulated and labeled, are unapproved drugs that need approval through NDAs before being sold in US, FDA says in warning. Separate websites firm operates for each brand continues offering sales.

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Scientific Solutions Global LLC's statement that it would stop distributing arnica-containing BioTemper topicals labeled for pain relief wasn't enough to keep the US Food and Drug Administration from warning it about crossing multiple OTC monograph boundaries.

The Carle Place, NY, firm also was outside the limits of an OTC monograph with its bare and Urea brand...

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