Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating.
Int J Pharm Compd
; 22(4): 303-312, 2018.
Article
em En
| MEDLINE
| ID: mdl-30021186
ABSTRACT
Compounding pharmacists must separately and collectively evaluate multiple aspects of a compounded sterile preparation when determining their beyond-use date. Considerations include the microbiological risk level, storage temperature, chemical stability, batch size, and whether or not a sterility test will be performed. The United States Pharmacopeia Chapter <797> provides guidance on the maximum beyond-use date allowed solely based on the microbiological risk level associated with the compounding of a sterile preparation. Compounders should select the shortest beyond-use date between the risk-level based beyond-use date and the chemical stability of the compound. When compounding pharmacists intend to provide a compounded sterile preparation with a beyond-use date that exceeds the risk-level based recommendations in United States Pharmacopeia Chapter <797>, they must ensure that their formulations are sterility tested in compliance with United States Pharmacopeia Chapter <71>. United States Pharmacopeia Chapter <71> compliance includes conducting method suitability that is applicable to the strength and batch size that they plan to prepare. Chemical stability must be a separate consideration for each formulation.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Composição de Medicamentos
/
Estabilidade de Medicamentos
Idioma:
En
Revista:
Int J Pharm Compd
Ano de publicação:
2018
Tipo de documento:
Article