The Compounding Quality Coalition Commends the FDA for its Continued Commitment of Protecting Public Health

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QuVa Pharma, Inc.; Compounding Quality Coalition

Sep 10, 2020, 12:44 ET

WASHINGTON, Sept. 10, 2020 /PRNewswire/ -- The Compounding Quality Coalition (CQC), comprised of a diverse, multi-sector group of stakeholders from public health, manufacturing, outsourcing facilities, and the pharmacy community, issued a public comment to Food and Drug Administration (FDA) notice entitled "Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities."

The CQC commends the FDA for its continued commitment of protecting public health by assuring access to safe and efficacious medicines are timely available to patients. The coalition appreciates the Agency's interest in developing a comprehensive understanding of the outsourcing compounding sector to address special patient and hospital needs that are unmet by commercially available products that have been approved by the FDA. The CQC firmly believes compounded drugs can meet these needs. Many hospitals in the U.S. have come to realize 503B registered compounding businesses are an essential component of their supply chain, to supporting patient safety and quality initiatives, and a key function in the operation of their pharmacies.

Hospitals turn to outsourcing compounding facilities for different circumstances including large scale batches, improved use by dates (i.e., Beyond Use Date—BUD), complexity of compounding (combination products and devices such as cassettes, pumps and others), drug shortages, and presentations, delivery devices, or formulations not otherwise commercially available. Hence it is critical that compounded drugs are manufactured in full compliance with applicable FDA standards and under conditions that guarantee potency, purity, and stability.

The coalition supports the FDA's efforts to ensure that 503B registered compounding businesses are highly regulated now and in the long run. Policies that ensure compliance with Current Good Manufacturing Practice (cGMP) regulations, proper facilities and appropriately skilled and trained staff are critical to the long-term health of our nation.

Moreover, the CQC's comment letter lays out principles for what a fully compliant 503B Compounding Outsourcing Facility (or business operating multiple facilities) should have:

A detailed and clear understanding of applicable legislative and regulatory polices at the Federal and State level.
Access to sufficient capital to develop the staff, facilities, and validated processes necessary to maintain sanitary conditions and fulfill the requirements noted above.
A coherent and complete set of Standard Operating Procedures.
Facilities which are designed to support the effective operation of those procedures.
A cadre of management and staff who have deep experience in sterile pharmaceutical manufacturing and interactions with the FDA to include experienced quality control and quality assurance staff.
Developed training and accreditation programs for all incoming manufacturing and quality staff.
Compliant product release, environmental and stability testing programs that meet appropriate standard to ensure safe and effective product for the patient.
Controls to ensure no release into the marketplace of any product until required testing is satisfactorily complete.
The ability to manufacture all its finished product from FDA approved pharmaceutical product whenever it is available, adhering to FDA guidance.
Appropriate manufacturing and quality controls if compounding from Bulk substances as allowed during shortages or other scenarios as directed by FDA (e.g., clinical need), and that FDA enforces its guidance equally (e.g., Essentially a Copy) across registered 503B compounding businesses to ensure fair trade.

Additionally, the FDA's commitment to patient safety is evident in its efforts to implement and enforce supply chain integrity by way of the DQSA. The CQC believes this effort will create a solid framework for compounded drug products distributed interstate and intrastate, further protecting the patients who rely on them. With that, the CQC commends the FDA's leadership and would like to extend our help in ensuring this bipartisan, public-health focused initiative is successful.

These efforts are particularly timely as a potential second wave of COVID-19 puts the nation at risk of quickly evolving surge demand for treatments and specialty formulations, and increased drug shortages that could hinder patient care and create greater reliance on compounded drugs.

About the Compounding Quality Coalition
The CQC is a diverse group of stakeholders from the public health, manufacturing, outsourcing facility, and pharmacy communities, such as Association for Accessible Medicines (AAM), QuVa Pharma, and others, whose goals align with the goals of the FDA to protect patients by ensuring that patients who have a clinical need for a compounded drug have access to the highest-quality product.