Hi Susan,
Yes, both can be done at the same facility. In fact, the facility should be able to manufacture Rx drugs in the same profile class (type of operation) with minimal updates.
If the facility has been manufacturing NDA-OTC (NDA process) products, it's most likely in a good shape to manufacture Rx drugs. Although Monograph-OTC (Monograph process) should have the same standards for safety/ efficacy, and GMP (inspections), the quality operation could be slightly different because pre-market approval is not a requirement for Monograph-OTC (e.g. SOPs for new drug submissions and PAI procedures...etc.). Oversight for Monograph-OTC occurs on a post-marketing basis.
As both Gaurang and Agieszka recommended, you should contact a RA/QA consultant first.
For Regulatory work, add the manufacturer's information to the application. Depending on the facility function and the application type, you will probably have to pay fees. Since the question is related to compliance, I will not go into details about new applications, amendments and supplements.
Best Regards,
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Tyng-Yi (Tina) Lee MS RAC
Consultant
North Brunswick NJ
United States of America
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Original Message:
Sent: 10-May-2017 15:42
From: AGNIESZKA WILKINS
Subject: entering OTC drug space
I cannot speak to the details of manufacturing both Rx and OTC products in the same facility (which should be inspected by FDA and GMP compliant), but I 'd like to clarify that it's not quite accurate that for OTC products there is no requirement for FDA oversight except labeling information submission. While it may be true to some extent for the monograph OTC products or dietary supplements, many of the OTC products actually do have the FDA oversight as well, as they go through the IND/NDA applications processes like any other Rx products.
Per FDA website:
"Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process."
Manufacturing of such products requires the same level of FDA oversight as Rx products.
You may want to consult with someone how to proceed with adding the manufacture of Rx products to your facility and qualification thereof.
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AGNIESZKA WILKINS
Morristown NJ
United States
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Original Message:
Sent: 09-May-2017 22:30
From: Gaurang Bhavsar
Subject: entering OTC drug space
Both can be done at same facility and many company do the same. They start with the OTC and eventually move to prescription drug manufacturing.
Things to keep in mind that prescription drug product handling requirement is more stringent than OTC products, so you must have system in place that follow both 21 CFR part 210 and 211.
Prescription drugs have more regulatory oversight by FDA as they are approving the product applications submitted by manufacturers, while OTC products there is no such requirement except labeling information submission.
Kindly contact regulatory consultant before you switch to or start prescription products in the existing facility that produces OTC.
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Gaurang Bhavsar
Edison NJ
United States
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Original Message:
Sent: 08-May-2017 16:03
From: Susan Jackson
Subject: entering OTC drug space
When authorized to manufacture OTC drugs by FDA, is there a system to upgrade to manufacture prescription drugs?
Or can a facility once they have a drug manufacting number can both be done.