Hi Sapna.
Simply put and as I explained in a previous thread - OTC products are still drugs. So all of the standard rules in 21 CFR 210/211 will apply to OTC products with the only real exception being that if the product is formulated and labeled in compliance with a monograph that is currently in effect the company will not need to submit nor await approval of an (A)NDA.
That said, here are answers in my experience to the questions you specifically raised:
· How many batches with the CMO are required? Generally you need to complete 3 validation batches to show that the process is in a state of control and all product must meet requirements of the specifications. Additionally, you will place the first production batch into stability to show that the product does not have stability issues when the production process has been followed according to the batch formulation sheet.
· Can we sell the exhibit batch if the stability checks out? Yes, you can sell the validation batches if all is acceptable. However, you must remember that your product will not be able to be sold until you can verify the proper shelf-life/expiration date so at minimum you will need to complete accelerated stability on the product. I have seen companies take risks to complete stability on only one production/validation batch before shipping but my opinion is that it is better to have multiple accelerated stability tests completed before moving to shipping. Reason is simple - if any of the stability tests are unacceptable you are in a recall situation with the first shipments of your product - not a good image to portray to the consumer or to the FDA.
· What is the registration process like as a marketing organization? Registration of the manufacturing site is the minimum. However, depending on what you as the marketing/selling company plan to do your firm could require registration as well (e.g. if you plan to perform drug listing yourself under your own labeler code, you will need to register as a labeler to perform that on your own.).
· What is the registration process like as the CMO? CMO will need to register their establishment at minimum as a drug manufacturer. Again, same rules apply here as would apply if this were to be manufactured and sold as a product with an active (A)NDA.
· What can the CMO expect to file with the FDA? What kind of involvement will the CMO have with the FDA? Simply to register? Formal Audit? Etc. The CMO as a manufacturer is likely to be inspected/audited by the FDA on a risk-based schedule depending on their compliance trend. Also, they will need to be prepared to manage all of the requirements of any of the FDA inspection process and systems just like any other drug producer. Again, the only difference here is that companies with (A)NDA products will need to be able to show the approved application while an OTC manufacturer is going to be required to provide evidence that the product is manufactured according to the requirements of the monograph(s) involved.
· Will the CMO need to be FDA approved? Again, the establishment must be currently registered with the FDA. Approval is not a part of the OTC process itself but you can expect that if a new manufacturer or manufacturing site just registering as a drug establishment it is more likely that the facility will receive and inspection in a shorter time than if the site or manufacturer has been inspected in the past as a drug production/manufacturing facility.
· What types of post marketing commitments must the marketing organization undertake? Commitments in the OTC world are generally compliance driven which means that you will need to ensure your labeling remains in compliance with any updates to the regulations (specifically the drug facts box labeling) and you will need to keep you records for QA and complaints available for inspection. So shipping, production, complaints, etc. - all the records you need to retain for (A)NDA products will also be required for OTC products.
· Does the 3 piece or 2 piece drooper need a DMF? You will need supplier controls in place for OTC production which means either you need to have the documentation required either available on-site or you will need a right of access. This does not have to be submitted to FDA unless it is specifically requested (no pre-submission on the part of the OTC company). Also, if this dropper is GMP-exempt you might not even require a DMF at all.
· Some of these API's of the OTC monograph are excipients in other Rx formulations, what grade of these API's will be required? APIs should be pharmacopeia grade materials whenever there is a USP monograph. If there is no USP monograph than if there is an NF or other pharmaceutical grade monograph to follow you should be following this. By regulation, if there is a USP monograph than you API must meet the requirements of the USP monograph in the United States.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 05-Feb-2024 23:10
From: sapna rathi
Subject: OTC guidance require
Dear All,
Greetings of the day.
Assume the products are as per the OTC monograph, we need guidance /input for the below points:
· How many batches with the CMO are required?
· Can we sell the exhibit batch if the stability checks out?
· What is the registration process like as a marketing organization?
· What is the registration process like as the CMO?
· What can the CMO expect to file with the FDA? What kind of involvement will the CMO have with the FDA? Simply to register? Formal Audit? Etc
· Will the CMO need to be FDA approved?
· What types of post marketing commitments must the marketing organization undertake?
· Does the 3 piece or 2 piece drooper need a DMF?
· Some of these API's of the OTC monograph are excipients in other Rx formulations, what grade of these API's will be required?
Your guidance/input is highly appreciated.
Regards,
Sapna
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sapna rathi
Regulatory specialist
AHME
India
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