n"i'''' ' ' ' '''"'"'n r. uiauuaLury. Biologics In the United States, although some biologics are regulated under the provisions of the Public Health Service Act (PHSA), provisions of the FDC Act also apply to these products. For this reason, products approved under the PHSA should comply with the adulteration and misbranding provisions of the FDC Act at Section 501(b) and 502(g) and, thus, should conform to applicable official monographs in USP-NF.