b.) Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.
The regulation has raised many questions for compounding professionals as well as for medical device suppliers.
Compounding centers found themselves required to institute and validate certain practices and procedures that were new to them.
They also were faced with the requirement for a defined and documented quality system.
Because of these new requirements, medical device suppliers have had to respond to the compounding centers' questions about the suppliers' products complying with as a.) Preparations prepared according to the manufacturer's labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination.
Now compounding professionals must be concerned with the design and classification of their filling cleanrooms, environmental monitoring, expiration dating, process validations, media-fill qualifications, sterility testing, and preparing a comprehensive quality manual.
However, these issues have been common practice in the medical device manufacturing industry for many years.
In , compounding facilities are instructed several times to refer to “manufacturers' labeled instructions” and to “consult the manufacturer of particular products for advice on assigning beyond-use dates on chemical and physical stability.” It is the responsibility of medical device manufacturers that produce the products to provide the compounding centers with this required information.
The FD&C Act recognized USP/NF as the official compendium of drug standards. Each general chapter of the USP/NF is assigned a number, which appears in brackets along with the chapter name.
The general chapters is a requirement, healthcare facilities that compound sterile preparations may be subject to inspection against it.