Comments regarding "Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph".
These comments are submitted in response to the public meeting of June 26 on evaluating drug names for similarities, which was co-sponsored by the FDA, PhRMA, and the Institute for Safe Medication Practices.
Letter to Daniel E. Troy, Esq. regarding whether there should be different trade-name evaluation procedures for different classes of drugs (Rx versus OTC).
CHPA supports the intent of the proposed rule to add a bar code to many medications intended to be dispensed in hospitals. We support the view that this rule will help arm busy healthcare professionals with technology to help avoid medication mistakes.
The Coalition is pleased that FDA has issued guidance that takes a risk-based approach to compliance. We strongly support this approach as a more realistic and effective way to protect public health.
CHPA is supportive of the FDA’s proposed regulation to implement Section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act. However, CHPA encourages FDA to make the implementation of the Act less burdensome on industry while ensuring the safeguards that Congress sought to construct for the American public.
CHPA is supportive of the FDA’s proposed regulation to implement Section 305 of the Bioterrorism Act. However, CHPA encourages FDA to reconsider its position with respect to the definition of food and the confidentiality afforded to the information provided to the agency.
