Decreto nº 5.775 de 10/05/2006. DISPÕE SOBRE O FRACIONAMENTO DE MEDICAMENTOS, DA NOVA REDAÇÃO AOS ARTIGOS 2 E 9 DO DECRETO 74.170, DE 10 DE JUNHO DE 1974, E DA OUTRAS PROVIDENCIAS.
DECRETO Nº 5.775, DE 10 DE MAIO DE 2006.
Dispõe sobre o fracionamento de medicamentos, dá nova redação aos arts. 2º e 9º do Decreto nº 74.170, de 10 de junho de 1974, e dá outras providências.
O PRESIDENTE DA REPÚBLICA, no uso da atribuição que lhe confere o art. 84, inciso IV, da Constituição, e tendo em vista o disposto na Lei no 5.991, de 17 de dezembro de 1973,
DECRETA:
Os arts. 2º e 9º do Decreto nº 74.170, de 10 de junho de 1974, passam a vigorar com a seguinte redação:
“Art. 2º ......................................................................................................................................
XVIII - fracionamento: procedimento que integra a dispensação de medicamentos na forma fracionada, efetuado sob a supervisão e responsabilidade de profissional farmacêutico habilitado para atender à prescrição ou ao tratamento correspondente nos casos de medicamentos isentos de prescrição, caracterizado pela subdivisão de um medicamento em frações individualizadas, a partir de sua embalagem original, sem o rompimento da embalagem primária, mantendo seus dados de identificação;
XIX - embalagem original: acondicionamento aprovado para fins de registro pelo órgão competente do Ministério da Saúde, destinado à proteção e manutenção das características de qualidade, de segurança e de eficácia do produto, compreendendo as embalagens destinadas ao fracionamento.” (NR)
“Art. 9º .............................................................................................................
Parágrafo único. As farmácias e drogarias poderão fracionar medicamentos, desde que garantidas as características asseguradas no produto original registrado, ficando a cargo do órgão competente do Ministério da Saúde estabelecer, por norma própria, as condições técnicas e operacionais, necessárias à dispensação de medicamentos na forma fracionada.” (NR)
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