On November 27, 2013, the Drug Quality and Security Act was signed into law.  This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new laws for “outsourcing facilities” that seek to compound large volumes of human sterile drug products without first obtaining an individual prescription.

Section 503A, an existing provision of the FDCA, provides that certain compounded human drug products were exempt from current good manufacturing practices, adequate directions for use, and new drug provisions of the FDCA.  However, in 2002, the U.S. Supreme Court deemed certain provisions within Section 503A relating to the advertising and solicitation of compounded products unconstitutional, leaving a great deal of confusion as to how FDA would enforce these provisions because of a Circuit split regarding the validity of Section 503A.  This new law removes the unconstitutional advertising and solicitation provisions that created uncertainty, enabling FDA to begin to enforce this section.  FDA also published a draft guidance addressing how the agency intends to enforce Section 503A and issued a request for public nomination of bulk drug substances that should make the list of approved bulk substances for compounding.  

The new law also creates a new provision under the FDCA, Section 503B.  Section 503B allows a compounding pharmacy to elect to register as an “outsourcing facility.”  A compounder that elects to register with FDA as an “outsourcing facility” can compound large volumes of sterile human drug products without first obtaining individual prescriptions and are exempt from certain requirements of the FDCA, including the adequate directions for use, the new drug requirements, and the drug tracing provisions.  Facilities that elect to register must comply with a number of provisions under Section 503B, including registration and reporting requirements, limitations on the types of drugs these facilities can compound, and fee and labeling requirements.  The full text of the Drug Quality and Security Act is available here.

Reporter, Caitlyn Ozier, Washington, D.C. +1 202 626 3731, cozier@kslaw.com.