Regulatory News

Capsule Supplier Changes: FDA Offers an Updated Policy

Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday.

Prior Approval Supplement

When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change.

Depending on the seriousness of the change, (e.g., whether the change has significant, moderate or minor potential to affect the safety or efficacy of a product), FDA may require companies to get approval before instituting the change via a PAS.

However, when the change is considered minor, drugmakers are only required to notify the agency in an annual report to the agency.

New Policy

According to the policy, FDA's Office of Pharmaceutical Quality (OPQ) says that merely changing the supplier of a hard gelatin capsule is a minor change and should only be included in an annual report.

The policy also states that if FDA receives a PAS containing a change in supplier, the agency will inform the supplier that the information needs only be included in an annual report.

Specifically, the policy says the annual report should include the following information:

• The name and address of the new capsule supplier
• Evidence that the capsule meets United States Pharmacopeial Convention and National Formulary (USP-NF) standards for hard gelatin capsules and is produced in a facility certified for bovine spongiform encephalopathy(BSE)/transmissible spongiform encephalopathy (TSE)
• Specifications for the new supplier's capsule that are consistent with those of the previous supplier's

However, FDA says that any change in the capsule's composition or appearance, including any changes in size, color, or dye, or a change from gelatin to a non-gelatin alternative, would require a PAS.

FDA