FAQ
- When performing contents verification via settle pressure/temperature check on medical gases, what is an acceptable tolerance?
- We are looking for information regarding the potential abuse of Nitrous Oxide. What is the current Industry Position in this area?
- We have a Dermatologist requesting NF Nitrogen to be supplied in an "Open Top Dewar". Can you provide some guidance on this practice?
- We have received a complaint from a patient using one of our medical gas products. They may have had an adverse reaction. Can you advise us how we should handle this incident?
- Am I required to include Expiration Dating on my Medical Gas Products?
- Another company currently fills our asset medical gas cylinders. We would like to remove their labels and apply our own labels. What are the regulations regarding this practice?
- We are a little concerned on what Documentation FDA would like to see regarding Internal Audits & Annual Management Program Review meetings. Are we required to show them these files?
- How often do we need to send our Servomex Paramagnetic Analyzer back to the factory / manufacturer for preventive maintenance and recertification?
- Who can we legitimately sell medical gas products too?
- Can I supply USP Oxygen to emergency responders such as lifeguards?
- I have a plumber customer requesting to purchase NF Nitrogen. Can I sell Medical NF Nitrogen to plumbers?
- 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. They are requesting USP Oxygen & Breathing Air. Is this correct? It will be used to support life, however it will not be dispensed or provided by an emergency responder or licensed healthcare provider. Any insight?
- 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?
- Do the calibration standards for my medical gas analyzers need to be certified to NIST?
- 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?
- How should I handle medical gas labels and what content is required to be on the labels?
- What are FDA Inspectors finding as violations in the latest round of inspections at Medical Gas facilities?
When performing contents verification via settle pressure/temperature check on medical gases, what is an acceptable tolerance?
Refer to the following B&R Compliance bulletin:
We are looking for information regarding the potential abuse of Nitrous Oxide. What is the current Industry Position in this area?
Refer to the following B&R Compliance bulletin:
We have a Dermatologist requesting NF Nitrogen to be supplied in an "Open Top Dewar". Can you provide some guidance on this practice?
Refer to the following B&R Compliance bulletin:
We have received a complaint from a patient using one of our medical gas products. They may have had an adverse reaction. Can you advise us how we should handle this incident?
Refer to the following B&R Compliance bulletin:
BR08-005 "FDA Related Complaint and Adverse Event Handling & Reporting Requirements"
Am I required to include Expiration Dating on my Medical Gas Products?
The industry has been working with the FDA for the last several years to resolve issues related to expiration dating and stability testing of medical gases. The Industry has submitted a citizens petition to exempt medical gases from compliance with the expiration dating requirements of 21 CFR 211.137. While FDA evaluates the data, they are not enforcing this requirement. However, if a firm's written procedures call for an expiration date, then they would expect a firm to be following their procedures and apply an expiration date to the product.
Another company currently fills our asset medical gas cylinders. We would like to remove their labels and apply our own labels. What are the regulations regarding this practice?
FDA regulations call for the name and address on the product label to be that of the manufacturer (filler) unless the name is qualified. If you want to use a label with your name on it, your name would have to be qualified with a phrase such as:
- "Filled for"
- "Manufactured for"
- "Distributed By"
We are a little concerned on what Documentation FDA would like to see regarding Internal Audits & Annual Management Program Review meetings. Are we required to show them these files?
"The Quality System Regulation provides that the requirement to make records available for inspection and copying by FDA officials does not apply to management reviews, quality audits, and supplier audits. An FDA employee may request under the requirements of the regulations, management with executive responsibility certify in writing that management reviews and quality audits have been performed and documented, the dates on which they were performed, and that "any required corrective action has been undertaken."
How often do we need to send our Servomex Paramagnetic Analyzer back to the factory / manufacturer for preventive maintenance and recertification?
While periodic preventative maintenance is always a good business practice, there is no regulatory requirement that the analyzer must be returned to the factory for recertification as long as the analyzer is performing properly.
Who can we legitimately sell medical gas products too?
Medical Gas Products are prescription legend drug products and can only be sold to the following entities:
- Licensed Practitioner (Doctor, Dentist, Veterinarian)(or in the case of Oxygen only a properly trained emergency responder)
- Licensed Healthcare Facility (Hospital, Nursing Home, Emergency Care Center)
- Another Distributor of Medical Gas Products i.e. Home Health Care Company (must be properly licensed to distribute medical gas products)
- Directly to the patient/end user (must have a copy of their current prescription on file)
Can I supply USP Oxygen to emergency responders such as lifeguards?
Refer to the following B&R Compliance bulletin:
I have a plumber customer requesting to purchase NF Nitrogen. Can I sell Medical NF Nitrogen to plumbers?
FDA has agreed to exercise enforcement discretion regarding the sale of Nitrogen NF to firms that install hospital medical gas systems. FDA has based their rationale in granting this dispensation on another national standard (NFPA 99). NFPA 99 specifically requires the use of Nitrogen NF in purging and pressure testing of healthcare medical gas piping systems. 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."
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. They are requesting USP Oxygen & Breathing Air. Is this correct? It will be used to support life, however it will not be dispensed or provided by an emergency responder or licensed healthcare provider. Any insight?
FDA has agreed to exercise enforcement discretion regarding the sale of USP Oxygen & Breathing Air used for breathing in "Mine Refuge Chambers." FDA's position is stated below:
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." FDA would not prohibit the sale of medical oxygen to any owner of a mine refuge chamber as long as proper documentation is presented to the oxygen supplier.
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. If you are a B&R SOP customer, or are using a copy of the GAWDA SOP manual developed by B&R, then you already have this requirement written into in your procedure manual in procedure #J-100 - Storage & Retention of Quality Records
Do the calibration standards for my medical gas analyzers need to be certified to NIST?
The short answer is yes. For additional guidance on the issue refer to the following B&R Compliance "Regulatory Update Bulletin".
What guidance can you provide regarding the selection and usage of Leak Detection Fluids?
Refer to the following B&R Compliance bulletin:
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?
Refer to the following B&R Compliance bulletin:
How should I handle medical gas labels and what content is required to be on the labels?
If you produce gases, which bear the "USP", or "NF" label you are a drug manufacturer. 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. Current Good Manufacturing Practices (cGMP's) relative to human drug products are found in 21 CFR, 210 and 211. Failure to comply with these requirements and the requirements of your own SOPs can result in serious consequences.
For Additional Information refer to the following B&R Compliance bulletin:
What are FDA Inspectors finding as violations in the latest round of inspections at Medical Gas facilities?
The most common types of cGMP citation violations have not changed significantly over the last few years. For a list of the most common violations found please refer to the following B&R Compliance bulletin:
For Additional Information refer to the following B&R Compliance bulletin: