November 12, 2012
As national organizations of pharmacists caring for patients in all settings, we offer our deepest
sympathy and condolences to patients and families affected by the fungal meningitis outbreak due
to contaminated injectable products. The pharmacy profession is dedicated to ensuring patient
safety and access to quality medications that meet patients’ needs. Based on our understanding of
this tragedy, the entity involved was engaged in unauthorized manufacturing of drug products, not
traditional pharmacy compounding.
Compounding is integral to all aspects of pharmacy practice. Pharmacists compound medications in
response to a prescription from a physician or other prescriber to customize a patient’s therapy and
meet patient-specific needs. Patients may receive compounded medications when they have a need
for a customized medication, when a drug shortage or product discontinuation occurs, when the
needed strength or dosage form is not available from a manufacturer, or when an allergen-free
version of a medication is needed. Pharmacists also compound prescriptions for veterinary needs.
Patients must continue to have access to high quality compounded medications that are not
available from a manufacturer. Pharmacists working in all practice settings such as hospitals and
health systems, community pharmacies, long-term care and assisted-living, and the facilities serving
our nation’s uniformed services work to ensure that quality compounding standards are met and to
comply with state board of pharmacy regulations. Importantly, all practice settings and health
professionals providing sterile compounding must follow quality standards. Pharmacies and
pharmacists may also be held to accreditation and certification requirements when compounding
preparations to further ensure quality and compliance.
The undersigned national pharmacy organizations and our colleague state pharmacy associations are
committed to working with state legislatures, and state boards of pharmacy which regulate the
practice of pharmacy. In addition, we will work with Congress, the Food and Drug Administration
(FDA) which regulates pharmaceutical manufacturing, and the Drug Enforcement Administration
(DEA) which regulates controlled substances. We will also collaborate with physicians, other
prescribers, and key stakeholders to prevent further tragedy.
We are a resource for policymakers and stakeholders in identifying a clear delineation between drug
manufacturing and traditional pharmacy compounding. We will advocate for state pharmacy boards
and FDA to have the resources they need for enforcement, and to ensure an appropriate balanced
approach for public safety and continued access to compounded medications.
Senior Vice President, Public Affairs
Director, Public Relations
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