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We request that FDA convene and consult an advisory committee on compounding to discuss the addition of semaglutide products to both DDC Lists and promulgate regulations adding semaglutide products to the DDC Lists.” 1 The FDA reviews 6 criteria to determine whether a drug or product belongs on the DDC Lists: complex formulation, complex drug delivery mechanism, complex dosage form, bioavailability achievement complexity, compounding process complexity, and physiochemical or analytic testing complexity
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La AEMPS aplica el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios (Real Decreto Legislativo 1/2015, que sustituyó a la Ley 29/2006) y el Real Decreto 1015/2009 sobre disponibilidad de medicamentos en situaciones especiales, integrados en el marco europeo de la Agencia Europea de Medicamentos (EMA)
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