President Obama signed the Drug Quality and Security Act (“DQSA”) into law on November 27, 2013. The DQSA contained provisions concerning the oversight of human drug compounding. For instance, it removed provisions of section 503A of the federal Food, Drug, and Cosmetic Act (“FDCA”) that the U.S. Supreme Court previously held were unconstitutional, thereby ensuring that the remaining provisions of section 503A are applicable nationwide. It also created a new section 503B, which allows a compounder to become an “outsourcing facility” and subsequently qualify for certain exemptions when the compounder registers with the FDA.
On July 2, 2014, the Food and Drug Administration (“FDA”) published a notice requesting that interested groups and individuals nominate bulk drug substances (active ingredients) that may be used by outsourcing facilities to compound drugs in accordance with section 503B. For the FDA to fully evaluate the inclusion of a bulk drug substance on the list, it requested specific information concerning: (1) the general background of the bulk drug substance, (2) the clinical need for compounding with the bulk drug substance, and (3) the drug product that will be compounded with the bulk drug substance. Nominations are due by September 30, 2014.
The FDA also published a proposed rule that would add 25 drugs to its list of drugs that cannot be compounded because they have been withdrawn or removed from the market because they are unsafe or ineffective. If the proposed rule is finalized, drugs included on the list will not be entitled to exemptions provided in sections 503A and 503B of the FDCA. Comments on the proposed rule are due by September 2, 2014.
Please contact our firm by August 1, 2014 if you would like to nominate a bulk drug substance for use in compounding or if you would like to comment on the proposed rule that will limit the drugs that can be compounded.