The FDA has developed a process to remove the “unapproved medical gas” label from certain drug listings.
Q&A
1. Who does this process apply to? Only the “original manufacturer” of the medical gas can be certified and receive the New Drug Application number from the FDA.
2. Who is the “original manufacturer”? The first company to produce the drug is the original manufacturer. For oxygen and nitrogen, this will be the bulk air separation plant. For carbon dioxide, helium and nitrous oxide, the original manufacturer will be the validated plant that produced the product from the non-medical raw material.
3. What about Medical Air, USP? It’s a little more complicated for medical air. If you produce medical air from the atmosphere with an air compressor, you are the “original manufacturer” of the medical air. If you blend Oxygen, USP and Nitrogen, NF together to make medical air, you are not the “original manufacturer”.
4. What is a “subsequent manufacturer”? Each company that processes the medical gas after the original manufacturer is the subsequent manufacturer. Most independent distributors who fill medical gases are subsequent manufacturers. If you fill medical oxygen cylinders and you do not own the ASU, you are a subsequent manufacturer.
5. What’s the regulatory basis for all this? Congress passed the Medical Gas Safety Act about 18 months ago as a part of the FDA reauthorization (FDASIA). One of the provisions of the Act was to remove the “unapproved” status from medical gases.
6. I fill medical air with a compressor (as the original manufacturer). What do I need to do to remove the “unapproved medical gas” label from my drug listing?
a. In the Spring of 2013, you should have completed the medical gas certification application. (If you still need to complete the application, let us know.)
b. The FDA should have sent you a letter titled “Acknowledge – Medical Gas Certification Request”. This letter should have included an NDA number.
c. Resubmit your listing for medical air and add the NDA number in the pull down menu. If you listing submission fails due to data validation issues, contact the SPL office and give them your “coreid” for the submission. The SPL office can override the data validation error and process your submission. If there are other errors on the X-Form, these errors should be corrected before contacting the SPL office for an override.
d. If AsteRisk, or another company, processed your FDA Drug Listing, have them resubmit your listing with the NDA number to remove the unapproved medical gas distinction.
7. How does a subsequent manufacturer (most independent distributors) remove the unapproved medical gas from it’s listing? The FDA is implementing a process to allow subsequent manufacturers to have the benefits of the “New Drug Application” without going through the certification process of the original manufacturer. Here are the steps:
a. Ask your bulk medical gas supplier for their NDA number on each bulk medical gas that you buy.
b. Update your drug product listing with their NDA number.
c. Handle data validation errors as above.
8. How can I verify that my FDA drug listing is not an unapproved medical gas?
a. Log on to: http://dailymed.nlm.nih.gov/dailymed/search.cfm
b. Enter your labeler code in the search window and all of your drug listings will be displayed.
If you have questions about this, or other FDA issues, please contact Tom Badstubner: tom@asteriskllc.com.