| 2003N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach | |||||||||||||||||||||||
| FDA Comment Number : | EC35 | ||||||||||||||||||||||
| Submitter : | Dr. Henry Chuang | Date & Time: | 07/31/2003 05:07:05 | ||||||||||||||||||||
| Organization : | Calgary Health Region | ||||||||||||||||||||||
| Category : | Health Professional | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| Dear Sir/Madam:
Under the 21 CFR 206.10 specifing requirement of code imprint on tablets and pills, is there a reason why FDA does not require imprinting of the drug name so as not to cause confusion among patients and medical staff especially in cases of overdose, and caregivers having to second guess the drug by its color and shape? Thanks. Henry T. Chuang, M.D. | |||||||||||||||||||||||