Compounders urge FDA to reject Wyeth petition
The International Academy of Compounding Pharmacy (IACP) has urged the FDA to reject Wyeth's citizen's petition to place restrictions on compounded bioequivalent hormone replacement therapy (BHRT). The petition "does not aim to protect women's health, just Wyeth's wealth," by trying to impose far-ranging restrictions on physicians' ability to prescribe and pharmacists' ability to compound BHRT, contended IACP executive director L. D. King.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
