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Under the FDAs Interim Policy on Compounding Using Bulk Drug Substances, the agency has stated that it does not intend to take enforcement action against pharmacies that compound with bulk drug substances listed in Category 1, provided the pharmacy otherwise complies with the conditions of section 503A

It was specially designed to reduce inflammation and relieve pain while minimizing stomach irritation, which is common with older NSAIDs, such as ibuprofen or Diclofenac

If a reconstituted vial accidentally freezes, thaw it slowly in the refrigerator (never at room temperature or under warm water), gently swirl to re-mix, and use it immediately rather than re-storing but expect measurably reduced activity compared to a never-frozen control

2012;28 Suppl 1:8-14