Conflicting State Compounding Regulations Create Barriers for FDA-Registered Outsourcing Facilities

Specialty Pharmacy Times

John S. Linehan, an Associate in the Health Care and Life Sciences practice, in the firm’s Baltimore and Washington, DC, offices, authored an article in Specialty Pharmacy Times, titled “Conflicting State Compounding Regulations Create Barriers for FDA-Registered Outsourcing Facilities.”

Following is an excerpt:

Since the passage of the Drug Quality and Security Act (DQSA) in 2013, the FDA has periodically released guidance that addresses compounding activities by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).

Although the federal government has taken steps to comprehensively regulate outsourcing facilities, many states have been slow to reform their pharmacy laws to align with the DQSA’s new legal scheme. As a result, many state laws present substantial obstacles for outsourcing facilities—particularly those operating across state lines—thereby threatening to undermine FDA and Congressional designs to foster the development of outsourcing facilities to better ensure an adequate supply of safely compounded drug products.