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Metabolic water production is estimated to represent on average approximately 250 to 350ml/day for sedentary persons ( EFSA 2010 ) but can increase up to 600 ml/day with strenuous physical activity ( Pivarnik and Palmer 1994 )

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Due to differences in the bioavailability of oral versus injectable formulations, further phase 3 trial evidence is needed to establish both efficacy and safety

However, this list is yet to be finalized and until the FDA evaluates and publishes a final rule regarding a substances inclusion on the 503A bulks list, the FDA has stated that it does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians who compound drugs using bulk substances provided the following circumstances are met: The bulk drug substance is listed in 503A Category 1 on the FDAs website