Must a manufacturer's package insert be followed as written, if it is written incorrectly?

A Blood Bank Compliance Officer in California comments that the AABB Standard (26th edition) 5.13.3.2 states: If the patient has been transfused in the preceding 3 months with blood or a component containing allogeneic red cells, has been pregnant within the preceding 3 months, or if the history is uncertain or unavailable, a sample shall be obtained from the patient within 3 days of the scheduled transfusion. Day 0 is the day of draw. In addition, the Code of Federal Regulations (21 CFR 606.151 (b)), states that standard operating procedures for compatibility testing shall include the following: (b) The use of fresh recipient serum or plasma samples less than 3 days old for all pretransfusion testing if the recipient has been pregnant or transfused within the previous 3 months. If a manufacturer's package insert is more restrictive than the above FDA regulations and AABB recommendations because of a misreading of the Code of Federal Regulations, must laboratories abide by the stricter (if incorrect) interpretation. In one manufacturer's package insert it states: "there is an FDA requirement that the specimen should not be stored for longer than 3 days of testing" with reference to CFR 21 CFR 606.151 (b). In this situation, is a facility required to perform any validation to assess the viability of the reagent if used on a specimen older than 3 days? Conversations with the manufacturer's technical services state that the 3 day rule in their package insert is only a recommendation.

Editors' Note: Please see an example CUSTOMER ADVISORY NOTICE of a package insert error.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator

The e-Network Forum is supported in part by the California Blood Bank Society (CBBS) and the American Red Cross Blood Services (ARCBS) and endorses collegial discussion among blood banking and transfusion medicine professionals. However, neither the CBBS nor the ARCBS in any way endorse the specific views and opinions expressed in the forum. The forum is not intended as a substitute for medical or legal advice and the content should not be relied upon for any medical or legal purposes. Readers should make their own determinations as to: (i) what constitutes appropriate medical, technical, and administrative practices, and (ii) how best to comply with laws and regulations relevant to their questions. For the latter, they should consider consulting, as to any medical matters, a qualified physician, and, as to any legal matters, an attorney familiar with related state and federal laws. The user of the forum, by accessing same, assumes all risks arising out of such use and releases CBBS and their respective members, directors, officers and agents from and against any loss, damage, claim or liability arising out of such use of the Forum.