Traditional Compounding Services Are Essential to Patients

Traditional pharmacy compounding is the preparation of individual prescriptions based on specific patient need and at the request of a prescriber. For decades, independent community pharmacists have provided patients with access to safe, effective and affordable medications through traditional compounding services.

The tragic meningitis outbreak of 2012 has been traced to contaminated medicines manufactured the Massachusetts-based New England Compounding Center (NECC). NECC purported to be a pharmacy and was regulated as such at the state and federal levels. In fact, NECC operated as a rogue pharmaceutical manufacturer without the proper approval from the Food and Drug Administration (FDA). In violation of its state pharmacy licensing requirements, the company mass produced thousands of drugs and shipped them all over the country, in many instances without first obtaining a valid prescription. This isolated case represents an extreme departure from traditional compounding.

When manufactured drugs aren't an option, independent community pharmacists provide traditional pharmacy compounding to prepare customized medications for patients in accordance with a doctor's prescription based on the patient's individual needs.

Here are some common examples of traditional compounding:

• Pediatricians may want medication flavored or converted into liquid form so that a child can more easily consume it.
• Some patients can't swallow pills. They may need their medications in a liquid, cream or gel format that is not otherwise commercially available.
• Manufactured drugs could trigger allergic reactions for some patients. In these cases, a pharmacist-compounded medication often becomes the only option.

Traditional compounding services can help bridge the gaps during times of prescription drug shortages. Drug shortages have nearly tripled, according to the FDA, and their impact can be devastating. Take the 2009 H1N1 (swine flu) outbreak, for instance. Across the country and with the support of federal health officials and Tamiflu's manufacturer, Roche, compounding pharmacists filled the void, as the Newark Star-Ledger and others reported.

Additional resources:

• New Regulations of Compounded Medicines Mean Fewer Options at Higher Prices
• Frustrating Search for Tamiflu Ends at Compounding Pharmacies
• As Congress Responds to Meningitis Outbreak: First, Do No Harm
• NCPA Comments to FDA Regarding a Framework for Pharmacy Compounding: State and Federal Roles - 01.18.2013
• NCPA Summary of an FDA Public Meeting: FDA Framework for Pharmacy Compounding State and Federal Roles - 12.19.2012
• Summary of Rep. DeLauro's Compounding Legislation
• NCPA Urges Congress to Preserve Patient Access to Traditional Pharmacy Compounding - 11.14.2012
• New Survey Affirms Compounding Pharmacies' Vital Role in Public Health - 11.13.2012
• Pharmacists' Commitment to Patient Safety and Compounding Quality - 11.12.2012
• NCPA Addresses Rep. Markey's Compounding Pharmacy Legislative Proposal
• Why Compounding Pharmacies Are a Necessity
  NCPA-IACP October 18, 2012 letter to The Washington Post
• NCPA and IACP October 10, 2012 letter to The New York Times
• Meningitis Outbreak Prompts Confusion About Compounding Pharmacies
  NCPA blog post
• NCPA Media Conference Call
• Pharmacist Compounding vs. Pharmacy Manufacturing
  November 2, 2012 edition of Executive Update (NCPA members only)