It’s Official-Capsule Supplier Change Will Likely Require a PAS

24 Mar.,2023


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I can’t tell you how many times over my 33-year career that firms have asked me how to submit (or what category of supplement, i.e., Changes being Effected (CBE), CBE-30 or Prior Approval Supplements [PAS]) a capsule supplier change would be. I also have heard from many different firms about what changes were allowed by FDA in an Annual Report, CBE-30, CBE, and PAS. I have always told firms that, unless the capsule composition (which includes the exact dyes, excipients, appearance [including size and shape], or change from gelatin to non-gelatin) did not change, a PAS was required. In some instances, firms had even received pushback from capsule suppliers regarding the submission type. But now, the $64,000 question has been answered by FDA. In addition, historically, the advice of submission type from FDA reviewers has also been somewhat inconsistent. I heard one story where a firm was making a change to two difference ANDAs for capsule supplier and submitted both as a CBE-0. One review group told the firm to submit it in the Annual Report and the other told the firm to submit the supplement as a PAS. In each application, the formulation of the capsule shells was slightly different from that of the original approved capsule shell. Today, FDA published MaPP 5016.6 (here) issued from the Office of Pharmaceutical Quality entitled “Change in Hard Gelatin Capsule Supplier.” The MaPP became effective upon publication and puts all of the quality reviewing chemists, as well as Project Managers, on the same page. Well, even though we don’t have the answer to the question “Which came first, the chicken or the egg?”, at least we now know what type of supplemental submission to make when a capsule shell supplier is made (based on any difference).

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