On April 15, 2016, the Food and Drug Administration (FDA) released three new draft guidance documents intending to clarify lingering questions surrounding the application and the enforcement of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act) that regulate the practice of pharmacy compounding. 

The Balanced Budget Act of 1997 (P.L. 105-33), Section 4541(c) [42 USC Sec. 1395l(g)(1)], applies annual, per-beneficiary financial limitations on expenses considered incurred for outpatient therapy services under Medicare Part B, commonly referred to as “therapy caps.” The limits are based on incurred expenses and included applicable deductibles and coinsurance.