As Digital Journal readers will be aware, as a results of articles we’ve been running since 2012, there have been a number of issues with U.S. compounding pharmacies and many recalls of medicinal drug products. The most serious (and notorious) of these was the New England Compounding Center (NECC), which released over 13,000 vials of methylprednisolone acetate injection from the Framingham, Massachusetts site. These were distributed across 23 states and later found to have been contaminated with a fungus, leading to multiple deaths and disabilities.
The report, titled “Best Practices for State Oversight of Drug Compounding,” indicates that, despite concerns in recent years, state oversight of compounding facilities varies considerably. Findings of concern are:
Only 50 percent of states require compounding pharmacies to comply with Food and Drug Administration (FDA) regulations for the manufacture of sterile drug products;
Some 60 percent of states do not require serious incidents, such as those with the potential for product adulteration, to be reported;
In contradiction to federal law, 28 states permit traditional compounding pharmacies to provide drugs without prescriptions for individual patients.
At the heart of these issues are tensions between state law and federal law, and who can intervene and regulate which activities of medicinal production. Although the Food and Drug Administration (FDA) enforces federal laws that apply to pharmaceutical products,
states are in most cases the primary regulators of pharmacy compounding. The Pew Charitable Trusts is campaigning for this to be reformed and for compounders to come under the same jurisdiction as other pharmaceutical manufacturing units.
As a sign of the importance of this subject, this week the FDA has alerted health care professionals and patients not to use drug products produced and distributed by I.V. Specialty Ltd., Austin, Texas. This is due to potential contamination with these medicines, which are intended to be sterile.
The issue relates to an inspection of the facility by the FDA. Here: “investigators observed insanitary conditions, including poor sterile production practices”, according to a report posted on Pharmaceutical Processing.
