6.1 Material/Component/Label Verification, Storage, and Handling

This page will address various regulatory issues related to this section of the GMP Institute framework.  Click below to view the issues that are relevant to you.

Do the CGMP labeling control requirements apply to medical gases packaged in cryogenic vessels?

Is pressure sensitive labeling on a roll considered to be cut labeling? 

Do the CGMP labeling control requirements apply to medical gases packaged in cryogenic vessels?

Reference: 
21 CFR 210.3, 
21 CFR 211 Subpart G, Packaging and Labeling Control, Sections 211.122 to 211.137; 
21 CFR Part 201, Labeling; 
Compressed Medical Gases Guideline, February 1989

Yes. Although we addressed this issue in the September 1995 edition of the NOTES, this matter continues to be an area of confusion and one of the most frequently asked questions we receive. Therefore, it is worth revisiting. Medical gases are not exempt from the general labeling requirements of 21 CFR Part 201. The filling of medical gases is considered a manufacturing operation and, as defined in 210.3, applying labeling to containers is also a manufacturing operation. Therefore, cryogenic vessels are subject to the labeling controls of Subpart G - Packaging and Labeling Control, Sections 211.122 - 137. This would include all high pressure cylinders, large dewars or cryogenic vessels, and home or patient vessels. 

Accordingly, any individual or firm filling cryogenic vessels, including patient or home vessels, is required to apply a drug label containing all of the required information and to follow CGMP labeling control measures.

See the medical gases guideline for additional information regarding labeling controls.

Contact for further information: Duane Sylvia, HFD-325, 301-594-0095, e-mail: sylviad@cder.fda.gov 

Reprinted from: FDA's HUMAN DRUG CGMP NOTES (Volume 7, Number 3) September, 1999.

Is pressure sensitive labeling on a roll considered to be cut labeling? 

References: 
See 21 CFR 211.122(g), Materials examination and usage criteria.

No, not unless peeled off the roll prior to being brought to the labeling line. Some misinformation appears to have been circulated in the pharmaceutical industry that FDA considers pressure sensitive labeling to be cut labeling -- this is not correct. Pressure sensitive labeling on a roll is roll labeling which does not require 100% verification, unless a firm wants to eliminate reconciliation, in which case 100% verification must be performed. However, if any type of labeling is received on rolls but is removed from the rolls by peeling them off or cutting off individual pieces prior to being brought to the labeling line, then we consider the pieces to be cut labeling.