Pharmacy Compounding

A Texas Perspective

Pharmacy compounding has experienced a resurgence as modern technology, innovative techniques and research have allowed more pharmacists to customize medications to meet specific patient needs.

With limited exceptions, all pharmacies and pharmacists are licensed and strictly regulated by state boards of pharmacy. Compounding is a core component of pharmacy and has always been subject to the oversight and monitoring of these agencies as determined by state law.

FDA Compliance Policy Guidance
In an effort to clarify FDA's oversight of medication compounded within the practice of pharmacy, Congress passed the Drug Quality and Security Act (DQSA) amending the Food, Drug and Cosmetic Act (FDCA) and signed it into law in 2013. The DQSA clarifies the role of compounding pharmacies (503A) and exempts pharmacy compounding from FDA drug manufacturer and outsourcing facility rules.

Prior to the passage of the DQSA in 2013, FDA circulated a draft Compliance Policy Guide to Congress that recognized office-use compounding as legitimate and permissible and explained how compounding pharmacists can engage in office-use compounding before the receipt of a patient-specific prescription consistent with the provisions of 503A. The draft guidance clarified state boards of pharmacy jurisdiction on the distribution of inordinate amounts of compounded drug products across state lines.

Since then, FDA's continuing, often misguided efforts to inspect compounding pharmacies has provoked Congress to provide additional legislative intent. A letter dated June 27, 2014, to FDA Commissioner Margaret Hamburg, signed by 32 members of Congress (eight from Texas) stated, "...pharmacies that produce small amounts of compounded products in advance of receiving a patient-specific prescription and practice within states where office-use is authorized and regulated by state boards of pharmacy should not be the focus of FDA oversight..." Following those efforts, Congress passed amendment language in a spending bill in late 2015, led by Texas Congressman John Carter that expresses grave concern from Congress that FDA has exceeded its authority under the DQSA by prohibiting all office-use compounding and restricting dispensing. The amendment went further in stating that the FDA report back to Congress within 90 days to address a Memorandum of Understanding concerning office-use compounding.

As a result, April 2016, FDA issued a subsequent draft guidance for industry entitled, "Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act." The draft guidance sets forth FDA's policy concerning certain requirements for compounding products, taking exception to the law and previous draft guidance, prohibiting products for office-use with minimal exceptions. The draft guidance is open for comment through July 15.

The Alliance is participating with DQSA Stakeholders (more than 30 organizations including the Alliance led by IACP, NCPA, and PCCA) in providing comments to the FDA Guidance and working with the U.S. House Appropriations Committee and other Congressional allies to offer an amendment in the Full Appropriations Committee markup, stripping funding for FDA's implementation of this draft guidance and clarifying the intent in FDCA to allow for 503A pharmacies to allow office-use in limited quantities under certain conditions.

Since then, the House Appropriations Committee on April 19, 2016, included report language in the FY17 FDA Appropriations legislation that passed out of the full committee acknowledging the Draft Guidance referenced above and directing that the Final Guidance document issued by the FDA allow for office-use compounding by 503A pharmacies.

DQSA Stakeholders have also sent a letter to all state boards of pharmacy that clarify the intent of language included in the most recent DQSA amendments to the FDCA -- limiting FDAs authority to regulate office-use compounding at the state level.

Texas Pharmacy Office-Use Compounding Laws
Texas laws define "office-use compounding" as the administration of a compounded drug to a patient by a practitioner in accordance with Chapter 562 of the Occupations Code. The Act further clarifies the provision of "office use" in "limited quantities." Section 562 was later amended (2013) to specify that pharmacies that compound sterile preparations must be inspected prior to license and requires that pharmacies notify the TSBP immediately of any adverse effects potentially attributable to a sterile product compounded by the pharmacy and not later than 24-hours after the pharmacy issues a recall for a sterile product.

Moving Forward
The Alliance will continue to align state and federal oversight of the compounding practice in favor of meaningful requirements for continued practice of "office-use" compounding. Because the pharmacy compounding practice has a necessary and important place on the list of health care options for many consumers, we will continue to work with our national allies and Congress to clarify and restrict the role FDA has in pharmacy compounding at the state level. We look forward to your input and suggestions going forward. We will continue to work with Congress and we will submit comments to the current FDA draft guidance to industry through the year.