SPL Implementation Guide

Section 2.3 Correction of IG Last sentence of the first paragraph in section 2.3 of the IG, which mentions telephone number and web address for reporting adverse reactions as part of contact party information.

Section 2.1 Note of change Section 2.1 of the IG gives different URLs for the style sheet and schema than used in the current release.

Response: The FDA web sites are being reorganized and these URLs should be used in R4 SPL instances.

Section 3.2.2 Can section 3.2.2 Labeling Text could be modified to explicitly forbid the use of the mixed content model of the <text> element. Response: The phrase in that section “The actual content is contained within a paragraph, table or list” effectively forbids the placement of content as a child of <text>.

General Q Keith asked if that interpretation indicated that the FDA policy concerning the IG was “anything that is not specifically allowed is forbidden”, even if it is allowed in the SPL schema.

Section 3.2.2.4 Clarification needed

Any restrictions on the content of user-defined bullets in the <item> element within unordered lists mentioned in section 3.2.2.4? An instance that had been returned supposedly because NLM couldn’t handle the symbol in question. Response: These are permitted, even if DailyMed does not display them. Any legitimate character, XML entity or Unicode symbol can be used, so that would not be a reason for rejection, and in any case NLM has no authority to reject an instance passed to it by the FDA, so there must have been some other coding error associated with the rejection.

Section 3.2.2.7 Correction to IG

Section 3.2.2.7 Hypertext Links still contains a reference to the ID attribute value of “an <id> … element”, where <id> should be <section>, as explained in the third bullet point under XML Details in section 3.2.1.