12/4/2013
The Food and Drug Administration (FDA)
this week issued proposed rules and guidances as the agency prepares to
implement Sections 503A and 503B of the Drug Quality and Safety Act.
ASHP will comment on several of the proposals to ensure that the regulations accurately reflect the compounding activities in hospitals and health systems. Members are encouraged to review the FDA’s proposals and share input with the Society’s Government Affairs staff.
To offer feedback on the proposed rules, review the items below and complete the survey by January 15, 2014.
Proposed Rules and Guidance
- Draft Guidance: Pharmacy Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Proposed Rule: Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- Proposed Rule: List of Bulk Drug Substances That May be Used to Compound Drug Products in Accordance with Section 503A of the Federal Food, Drug, and Cosmetic Act
- Proposed Rule: Bulk Drug Substances That May be Used to Compound Drug Products in Accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act
- quoted from here
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