Indexing Structured Product Labeling

Description

This guidance explains that FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will index the content of labeling for human drug and biological products using SPL (Structured Product Labeling). Indexing refers to the insertion of machine-readable tags, which do not appear in actual printed labeling, that enable users with clinical decision support tools and electronic prescribing systems to rapidly search and sort product information. This guidance also describes how applicants can participate in the SPL indexing process. Having consistently and accurately indexed content of labeling is an important step toward the creation of a fully automated health information exchange system.

Scope & Applicability

Regulatory Context

• 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .

  The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

• 21CFR314.81§ 314.81 Other postmarketing reports.

  (a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 21CFR601.14§ 601.14 Regulatory submissions in electronic format.

  (a) General. Electronic format submissions must be in a form that FDA can process, review, and archive. FDA will periodically issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files.)Read full regulation →

• False & Misleading Claims/Misbranded

  Novo Nordisk Inc.

  2025-09-16

• False & Misleading Claims/Misbranded

  Eli Lilly and Company

  2025-09-16

• False & Misleading Claims/Misbranded

  Sprout Pharmaceuticals, Inc.

  2025-06-10

• False & Misleading Claims/Misbranded

  Sarfez Pharmaceuticals, Inc.

  2025-05-20

• False & Misleading Claims/Misbranded

  CooperSurgical, Inc.

  2021-02-23

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