- FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
- FAQ « B&R Compliance Associates
NFPA 99 is the national standard for health care facility medical gas piping systems, and FDA participated directly in the development of elements of the code. While the practice seems to be acceptable in the FDA's eyes at this time, it is recommended that if you are going to sell to this market, you obtain a letter from the plumbing company stating that "They understand they are obtaining a drug product and will only use it for the intended purpose of purging and pressure testing of healthcare medical gas piping systems.
FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
We service several coal mines in the area. They are constructing "safe rooms" that are designed to be used in case of events like the one in West Virginia when the miners were trapped underground. It will be used to support life, however it will not be dispensed or provided by an emergency responder or licensed healthcare provider.
The oxygen used in these mine refuge chambers would be considere "oxygen for environmental use" which FDA defines as "oxygen that meets USP specifications and is used to support life artificially in environments that are normally deficient.
While the practice seems to be acceptable in the FDA's eyes at this time, it is recommended that if you are going to sell to this market, you obtain a letter from the owner of the mine refuge chamber stating that "They understand they are obtaining a drug product and attesting that the use of the Medical Oxygen and Breathing Air would be restricted to use in their chamber.
I recently received a GAWDA compliance alert regarding the need to file a copy of our medical gas label with each batch production record or fill log. Is this a new requirement?
This requirement is not new, and the majority of medical gas firms have been aware of and complying with this requirement for years by storing fill logs in a folder or binder with the label in use on product for that time period on the front. Do the calibration standards for my medical gas analyzers need to be certified to NIST?
The short answer is yes.
What guidance can you provide regarding the selection and usage of Leak Detection Fluids? During a conversation with my state agency the issues of how we assure Medical Gas Product Integrity following a natural disaster was raised. How should this be handled?
FAQ « B&R Compliance Associates
How should I handle medical gas labels and what content is required to be on the labels? As such, the FDA expects you to comply with Current Good Manufacturing Practices which includes maintaining strict physical control over labels and procedures to ensure that labels are current and conform to specification. Failure to comply with these requirements and the requirements of your own SOPs can result in serious consequences. The most common types of cGMP citation violations have not changed significantly over the last few years.
Who can we legitimately sell medical gas products too? If you want to use a label with your name on it, your name would have to be qualified with a phrase such as: Medical Gas Products are prescription legend drug products and can only be sold to the following entities: The FDA states that this action was taken in response to " an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose.
The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products ". Compliance Policy Guide In addition, once final, it will supersede Compliance Policy Guide Comments regarding the draft document should be submitted within 60 days of publication.