FDA Responds to IACP Outsourcing Letter
IACP has been closely monitoring the U.S. Food & Drug Administration's (FDA) communications and activities regarding the newly established Outsourcing Facilities (OF). We are concerned regarding several areas on which we believe FDA has failed to provide guidance, causing considerable confusion for pharmacies. For example, the FDA sent letters to the States and to hospitals requesting that the hospitals only do business with registered OFs. FDA also asked States to implement a requirement that anyone who ships into their state to be registered as an OF. However, FDA hasn’t inspected any of these recently registered OFs; they have delayed the reporting requirements to OFs that register; and, FDA hasn’t developed any of the lists that dictate what OFs can compound. In addition, FDA hasn’t clarified with any pharmacies wishing to register as OFs whether they have to comply with the cGMPs, or whether FDA is drafting an alternative standard that will be enforced at these OFs. Thus, OFs are being asked to register, and they don’t even know to which standard of compliance they will be held.
With so much uncertainty, IACP sent a letter to the FDA asking that they cease sending letters endorsing these facilities when they haven’t developed any of the guidelines they were authorized to develop under HR 3204. This week, IACP received FDA’s response. Click here to read IACP's letter to FDA. Click here to read FDA's subsequent response.
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 and the state legislatures who decide upon the way pharmacy compounding should be regulated within their borders. Additionally, the Food & Drug Administration has authority over some aspects of compounded prescriptions at the federal level under the direction of Congress. Standards set by the United States Pharmacopeia (USP) are integrated into the day-to-day practice of pharmacy compounding and are mandated by law in most states. Even greater oversight comes through accreditation from a variety of non-profit agencies that establish and survey on guidelines designed to improve quality in the compounding process.
Click here for FDA’s letter to hospitals promoting OFs
Click here for FDA's letter to States promoting OFs
Click here for IACP’s letter to FDA regarding promotion of OFs to States and hospitals
Click here for the FDA’s response to IACP
See Inside Health Policy article below.
Jurisdictional Issues Surface As States Mull Outsourcing-Facility Licensing
Posted: March 20, 2014
States are confused about how to apply licensing requirements to FDA's newly created category of outsourcing facilities, an International Academy of Compounding Pharmacists official said, citing an area that needs clarification as FDA implements the Drug Quality and Safety Act (DQSA). Sen. Lamar Alexander (R-TN), ranking member of the Senate health committee, recently touched on the issue in a hearing, saying states are considering laws that would also regulate outsourcing facilities.
David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists (IACP), said compounding pharmacies, like drug manufacturers, are involved with distributors, making states unsure about whether outsourcing facilities can be regulated under the Prescription Drug Marketing Act. The 1987 law requires a state license to engage in wholesale distribution in interstate commerce.
Miller pointed to bills being considered in Florida and California that would prohibit nonresident compounding pharmacies from shipping drugs into the state without a license or a permit. These measures could also affect firms registered with FDA as outsourcing facilities. The Florida bill specifies that outsourcing facilities must hold a state permit to distribute in the state.
Other states, Miller said, don't know what to do. "Both flags are on the flagpole" for outsourcing facilities, he said, using an analogy made by lawmakers. "Until we get clarification, this is a gray area that will keep getting grayer," he said.
The intent of DQSA was to allow companies to choose to be regulated by the state or FDA, Alexander said, pressing FDA commissioner Margaret Hamburg for details about state laws applying to outsourcing facilities.
Hamburg told the Senate Health, Education, Labor and Pensions Committee that she had heard the opposite from states.
"What I've heard from states is that when there are these large facilities that are manufacturing high-risk injectable products, they often don't feel equipped to provide that regulatory oversight," she said. "They hope [these facilities] will register with the FDA."
DQSA, which was passed last year, created a new section, 503B of the Food, Drug and Cosmetic Act, in which large compounding pharmacies can voluntarily register with FDA and meet federal requirements for quality and inspections. Compounding facilities that do not to register must comply with manufacturing exemptions under section 503A, or be considered a drug manufacturer. The law was intended to clear up state and federal jurisdictional issues that were at issue during a deadly nationwide outbreak tied to drug compounding.
So far, 33 facilities are registered as outsourcing facilities, according to FDA records.
At the hearing, Hamburg also said that there are holes in the regulatory oversight of large compounding pharmacies. She said she is concerned that compounding pharmacies who aren't registered with the agency could be out of compliance with provisions of the law, but FDA may not know they even exist.
Hamburg also told the senator that the Good Manufacturing Practices (GMP) guidelines for outsourcing facilities under 503B is a top priority for the agency and they will be released as quickly as possible.
This discussion was part of a hearing held by the committee to examine FDA's initiatives in various areas, including developing abuse deterrent opioids, oversight of compounding facilities and food safety among other topics. -- Erin Durkin
IACP is continuing to monitor this situation, and will provide updates as they occur. Please email IACP at firstname.lastname@example.org with any questions.