Proposed 1st Edition of Cell and Gene Therapy Standards for Pharmacy

The proposed first edition of Cell and Gene Therapy Standards for Pharmacy is available for public comment from October 16, 2024 to December 16, 2024.

After the conclusion of the comment period, the Cell and Gene Therapy Standards for Pharmacy Committee will meet to review all comments submitted. The first edition is slated to go into effect in spring 2025.

To Comment on the Proposed Standards:

  1. Submit comments by December 16, 2024 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.


Proposed 1st First Edition of Cell and Gene Therapy Standards for Pharmacy (PDF)​