Potential Risks of Pharmacy Compounding

Why do we need quality assurance for pharmacy compounding in the future?


"Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients.

Approved drugs are made and tested in accordance with good manufacturing practice regulations (GMPs), which are federal statutes that govern the production and testing of pharmaceutical products. In contrast, compounded drugs are exempt from GMPs, and testing to assess product quality is inconsistent. Unlike approved drugs, pharmacy-compounded products are not clinically evaluated for safety or efficacy. In addition, compounded preparations do not have standard product labeling or prescribing information with instructions for safe use. Compounding pharmacies are not required to report adverse events to the regulator, which is mandatory for manufacturers of regulated medications. Some pharmacies engage in activities that extend beyond the boundaries of traditional pharmacy compounding, such as large-scale production of compounded medications without individual patient prescriptions, compounding drugs that have not been approved for use, creating copies of approved drugs. Compounding drugs in the absence of GMPs increases the potential for preparation errors. When compounding is performed on a large scale, such errors may adversely affect many patients. Published reports of independent testing by for an example the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. (Gudeman, Jozwiakowski, Chollet, Randell, 2013)




Patients and healthcare practitioners need to be aware that compounded drugs are not the same as generic drugs, which are approved by the FDA or other regulator. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment.


Quality Issues with Compounded Medications


The FDA became aware of 55 product quality problems associated with compounded medicines between 1990 and 2001. The agency therefore conducted a limited survey of 29 different compounded medicines sourced from 12 compounding pharmacies, testing 8 different drugs of various dosage types (oral, injectable, topical, etc.) against established quality standards. Ten out of 29 samples (34 %) failed quality testing, mostly for sub-standard potency ranging from 59 to 89 % of the target dose. By comparison, the FDA noted that the failure rate for over 3,000 FDA-approved commercial products tested from 1996 to 2001 was <2 %. The FDA conducted a follow-up survey in 2006 and found that 12 of the 36 compounded products (33 %) failed quality testing. Most of the failures were again related to potency, ranging from 68 to 268 % of the labeled dosage. The FDA concluded that the compounding processes used at pharmacies most likely caused the quality failures and reiterated that this rate of failure raises public health concerns for compounded drugs.


Annual testing of randomly selected compounded drugs by the Missouri Board of Pharmacy covering the years 2005–2009 showed failure rates between 11.6 and 25.2 %, with potency ranging from 0 to 450 % of the labeled dosage. The Ohio State Board of Pharmacy performed similar testing of compounded drugs in 2007, which found potency results ranging from 27 to 87 % of the labeled dosage and 1,380 doses of fungally contaminated products. Thousands of the purportedly sterile compounded products that were examined had not undergone appropriate sterility testing. Over the period 2008–2010, the Texas State Board of Pharmacy found an overall potency failure rate of 23 % for compounded drugs.” (Gudeman,Jozwiakowski, Chollet, Randell, 2013)


Curify's technology offers quality control of compounding drugs.


Reference: doi: 10.1007/s40268-013-0005-9

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