The outbreak of meningitis caused by contaminated methylprednisolone acetate compounded by the New England Compounding Center last fall put the spotlight on sterile products outsourcing. In the aftermath of the incident, ASHP has worked
with policymakers, practitioners, and nationally recognized experts in compounding and manufacturing to develop new approaches to protect patients from preventable harm, and to give practitioners and organizations confidence that compounding outsourcers are appropriately regulated and inspected, and that the products they produce are safe.
Working with Experts
In February, ASHP partnered with The Pew Charitable Trusts, and the American Hospital Association to hold a Summit
that explored the scope of pharmacy sterile compounding and the associated risk factors, the differences between sterile production expectations under Current Good Manufacturing Practices and United States Pharmacopeia <Chapter 797>, and oversight roles for states and the federal government. Recommendations from the Summit will be released in April.
ASHP has worked to educate policymakers and others about what distinguishes patient-care driven hospital and health-system based IV admixture services from commercial sterile compounding outsourcing. ASHP has also advocated to preserve the important role that credible compounding outsourcers’ play to help supply hospitals and health systems with sterile products that are in short supply, customized dosage forms, high-risk level sterile preparations, and repackaged medications from FDA-approved products.
The Society has urged the Food and Drug Administration
(FDA) to require compounding service providers
that operate at the scale and scope of manufacturers to register with the agency, share details about their operations, and submit to routine inspections. Current discussions center on the FDA oversight of a “third category” of vendors—companies that prepare sterile preparations without patient-specific prescriptions and ship them across state lines. FDA is exploring what criteria must be met for these entities to be under the FDA's jurisdiction versus traditional state pharmacy scope of practice laws.
ASHP continues to work with Congress on strategies to address the regulatory gaps with respect to sterile preparations that are mass produced and often shipped to customers across state lines. Much of the discussion thus far has focused on the third category of vendors and how broadly the category needs to be defined. Further, discussion has focused on ensuring there are no unintended consequences that would enable a large sterile preparation entity to bypass the New Drug Application and Abbreviated New Drug Application requirements set forth for manufacturers.
The Society is also collaborating with state affiliates
to monitor activity in state legislatures and boards of pharmacy. California, Maryland, Massachusetts, New Jersey, South Carolina, Tennessee, and Virginia are among the numerous states taking action on compounding.
To support ASHP's continued advocacy efforts, a member survey is being conducted to gain information on sterile compounding and the use of outsourcing vendors by health systems.
ASHP continues to provide members with up-to-date information on the compounding issue, including timely notification of compounded product recalls via the online Sterile Compounding Resource Center, news capsules, and ASHP Connect. The Society is also continuing its efforts to address drug shortages, which may play a role in the decision to obtain products from an outsourcing supplier. The Society continues to work closely with officials in the FDA’s Drug Shortages Program to help assess the situation and provide perspectives on the impact of shortages on patients and providers.
Resources for Members