Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -9

Accepted - Volume 6

Comment Record
Commentor Dr. Michael Durschlag Date/Time 2003-03-18 16:19:12
Organization Allermed Laboratories, Inc.
Category Company

Comments for FDA General
Questions
1. General Comments Response to Docket No. 02N-0204 This letter is in response to your notice in the Federal Register of March 14, 2003 entitled “Bar Code Label Requirement For Human Drug Products and Blood”, and specifically addresses your request for comments under section VIII.8., which reads, “Whether any specific product or class of products should be exempt from a bar code requirement and the reasons why an exemption is considered to be necessary…” We request modification of proposed section §201.25(b) to exclude allergenic extracts. We believe that the class of biological products known as allergenic extracts should be excluded from this rule. The rule is specifically concerned with reducing medication errors of products used in a hospital setting. Allergenic extracts are a class of products encompassing hundreds of different antigens extracted from naturally occurring plants and animals. They are generally sold directly to physicians, physician group practices and clinics that are outside of the hospital setting. The vast majority of the users of these products would have no access to machinery capable of reading bar codes and no incentive to purchase such equipment. Secondly, the proposed rule states under §201.25(c)(1), “Each drug product described in paragraph (b) in this section must have a bar code that contains, at a minimum, the appropriated National Drug Code (NDC) number…” Currently, allergenic extracts have not been assigned NDC numbers and it would therefore not be possible to design a label containing a bar code for these products. A third reason why allergenic extracts should be excluded from this rule is that many of the products are manufactured to a physician’s prescription. There is an indefinite number of possible mixtures of products that could result from a physician’s prescription and therefore there would need to be an indefinite number of bar codes issued. Many bar codes would only be used infrequently or only once. We believe that these comments offer sufficient reason for the exclusion of allergenic extracts from the rule.




EC -9