FDA Still Finds Safety Issues at Compounding Pharmacies By Tod Aronovitz | 04/24/13 | 0 Comment

Patients who take specialized drugs produced at compounding pharmacies may face increased safety hazards, according to inspection results recently released by the U.S. Food and Drug Administration.

Significant risk for contamination of drug products made at compounding pharmacies still exists, according to details posted on the FDA website earlier this month. The agency has stepped up its focus on these specialized pharmaceutical centers in the wake of 53 deaths from a fungal meningitis outbreak starting last September which was found to be caused by unsanitary drug production procedures.

The agency observed practices at 31 compounding pharmacies known to have produced high-risk sterile drug products in the past to determine whether they posed a significant threat to public health from poor sterile drug conditions currently.

As of April 11, FDA investigators found in 28 of the 29 completed priority inspections:

  • Incomplete and/or inadequate drug product batch failure investigations
  • Inappropriate and/or inadequate clothing for sterile processing
  • Lack of appropriate air filtration systems
  • Insufficient microbiological testing
  • Other practices detrimental to sterile production

One of the compounding pharmacies inspected was Lowlite Investments, d/b/a Olympia Compounding Pharmacy, located in Orlando, Florida.

After thoroughly evaluating all the data, the FDA will apply existing legal authority to protect public health if applicable. Under current regulations, the FDA may not be able to take action against firms that meet certain criteria and are operating within the bounds of traditional pharmacy compounding, but the agency is working closely with the state boards of pharmacy and referring the appropriate cases to them when necessary.

Background on Compounded Drugs

Typically a state board of pharmacy oversees compounding pharmacies within state boundaries. Compounded drugs are not approved by the FDA in regard to quality, safety, effectiveness, or manufacturing standards.

Pharmacy compounding is frequently used in the following types of cases:

  • Patients with an allergy require medication made without a certain dye
  • Medication in a liquid form is needed for an elderly patient or child who can’t swallow a pill

Talk to your doctor or pharmacist if you have questions about your medications.

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