FDA发布FDA-2009-D-0212最终指南，涉及固体口服制剂防伪用物理化学标识物
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
FDA发布最终指南FDA-2009-D-0212，面向希望在固体口服制剂中使用物理化学标识物（PCID）的药品生产企业。文件将PCID定义为具有独特物理或化学性质、可唯一识别和鉴证药品或其剂型的物质或物质组合。该指南由FDA药品评价与研究中心发布，公众可随时在线或书面提交意见，书面意见需注明文件编号FDA-2009-D-0212。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2009-D-0212
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This document is intended to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs). A PCID is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2009-D-0212.
来源：FDA Pharmaceutical Quality Documents · fda.gov