1. Food and Drug Administration. Expiration dating. 21 CFR 211.137.,2009
2. Food and Drug Administration. Stability testing. 21 CFR 211.166.,2009
3. Food and Drug Administration. Warehousing procedures. 21 CFR 211.142.,2009
4. Food and Drug Administration. Requirement to establish a production and process control system. 21 CFR 111.75.,2009
5. Food and Drug Administration. Guidance letter regarding the Prescription Drug Marketing Act of 1987: docket no. 88N-248L.,1988