Proposed 13th edition of Standards for Biotherapy Services

The proposed 13th edition of Standards for Biotherapy Services is available for public comment from Friday, August 14, 2026 until Tuesday, October 13, 2026. A summary of significant changes is provided to facilitate review of the proposed Standards.

After the conclusion of the comment period, the Biotherapies Standards Committee will meet to review all comments submitted.  The 13th edition will go into effect on July 1, 2027.

To Comment on the Proposed Standards:

1. Submit comments by October 13, 2026 through the fillable form.  Users can also submit comments via email to standards@aabb.org
2. Include name and postal address/fax number/email address, as appropriate.
3. Identify the standard by its number at the beginning of the comments. This identification is especially helpful if you comment on more than one standard.
4. Provide alternative wording if you think it would improve the clarity of a standard. If you agree or disagree strongly with a proposed change, please state your reasons or submit data.

Summary of Significant Changes and Proposed 13th edition of Standards for Biotherapy Services (PDF)​