What is required to support changes to API Manufacturers in OTC Drugs?

H

HBoland

Hello,

I am looking for an FDA regulation or guidance that will tell me about changes to the manufacturer of the API in an OTC drug and any associated requirements. I have looked into the SUPAC Guidance, but it only seems to cover excipients.

Please forgive me if this is a simple question, I am transitioning from the device world.

Thank You,
HB
 
H

HBoland

Re: What is required to support changes to API Manufacturers in OTC Drugs ?

Ajit,

Thank you for your reply. I had skimmed ICH Q7A earlier, but I took a closer look after you recommended it. We do have a formal change control process, so I will rely on that.

Just as 510(k)s are somewhat ambiguous when compared to PMAs, it seems that OTCs are also ambiguous compared to NDAs/ANDAs.

If anyone is aware of other helpful OTC guidances, please let me know!

Thank You,
HB
 
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