OMB control number
Bar Code Label Requirements for Human Drug Products and Biological Products
OMB 0910-0537 · HHS/FDA.
OMB 0910-0537
This ICR collects information regarding waiver requests or exemptions from bar code requirement regulations. A request that FDA waive the bar code requirement for a particular drug product must include the following information: (1) Compliance with the bar code requirement would adversely affect the safety, effectiveness, purity, or potency of the drug or not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps; or (2) an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.
The latest form for Bar Code Label Requirements for Human Drug Products and Biological Products expires 2022-08-31 and is listed under ICR 201907-0910-019.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0537 Bar Code Exemptions SSA 2019 Ext.pdf | Supporting Statement A |
 Exemption Request from Bar Code Label Requirements |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201907-0910-019 | Extension without change of a currently approved collection | 2019-07-22 | Approved without change | |
| 201607-0910-006 | Extension without change of a currently approved collection | 2016-07-25 | Approved without change | |
| 201306-0910-001 | Extension without change of a currently approved collection | 2013-06-05 | Approved without change | |
| 201005-0910-006 | Extension without change of a currently approved collection | 2010-05-17 | Approved without change | |
| 200702-0910-008 | Extension without change of a currently approved collection | 2007-02-21 | Approved without change | |
| 200401-0910-010 | New collection (Request for a new OMB Control Number) | 2004-01-28 | Approved without change |