Manufacturing Guidelines Play Vital Role in Safety of Compounded Drugs

Overview

Compounded drugs can serve an important role for patients whose clinical needs cannot be met by medications approved by the U.S. Food and Drug Administration (FDA). While these drugs are generally prepared for individuals based on a patient-specific prescription, medical providers may also seek non-patient-specific supplies of compounded drugs—known as office stock—to administer in an outpatient or hospital setting. For example, many hospitals maintain stocks of compounded injections to relieve pain that can be administered to patients with an immediate need. Under federal law, only certain compounders known as outsourcing facilities can compound and distribute non-patient-specific drug products for use as office stock.

Office stock products present risks. They are often stored before use, which increases the opportunity for contaminants such as bacteria and fungus to grow to dangerous levels, or for ingredients to deteriorate, which can cause drugs to become less potent or degrade in ways that pose safety concerns. Also, because such drugs are sometimes produced at significant scale, more patients are potentially exposed if products are contaminated or otherwise substandard.

To reduce these risks, outsourcing facilities must comply with Current Good Manufacturing Practice (CGMP) requirements, issued by FDA, that also apply to conventional pharmaceutical companies. The table below highlights key CGMP topics from draft guidance FDA issued in December 2018, and provides examples of how these guidelines decrease risks to patient safety.