Question
|
Response
|
| 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:
BR08-003
"Content Verification" |
| 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:
BR08-002
"Abusive use of Nitrous Oxide" |
| 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:
BR08-004
"Nitrogen Open Top Dewar Filling for Medical Use" |
| 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:
BR08-006
"Emergency Oxygen: Drug or Non-Drug?" |
| 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".
ComplianceBulletinBR11-001.pdf
|
| What guidance can you provide regarding the selection and usage of Leak Detection Fluids? |
Refer to the following B&R Compliance bulletin:
ComplianceBulletinBR10-003.pdf
|
| 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:
ComplianceBulletinBR10-001.pdf
|
| 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:
ComplianceBulletinBR09-003.pdf
|
| 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:
ComplianceBulletinBR10-002.pdf
|
