On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies. The Order as well as supplemental guidance issued by the Board of Registration in Pharmacy (Board) is effective as of March 24.
Continue Reading Massachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy Professionals

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
Continue Reading FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). As emphasized in a recent U.S. Department of Justice policy memorandum, FDA noted that its guidance documents do not establish legally enforceable responsibilities and, instead should be viewed only as agency recommendations, unless specific regulatory or statutory requirements are cited.


Continue Reading FDA Issues New Compounding Guidance