Compounding Medication Facts
Compounding medication is the act of altering certain medications to meet the needs of patients. It may involve combining two or more drugs or mixing ingredients; however, the FDA does not approve compound drugs.
Why Patients May Require Compounded Drugs?
There are times when a patient may be in need of a certain medication that is FDA-approved but is unable to take it for various reasons. Some patients may be allergic to one of the ingredients in the FDA-approved medication, such as a certain dye. Others, like the elderly or young children, may not be able to swallow medication in a pill form, and therefore, require a liquid to be made. These are just some of the reasons why practitioners provide compounded drugs to patients.
Who Can Compound Drugs and in What Settings?
While compounding can occur in many different settings, it usually takes place in pharmacies.
Federal laws address compounding services in a federal facility or a state-licensed pharmacy by a licensed pharmacist, a licensed physician, or in an outsourcing facility under the supervision of a licensed pharmacist. The Drug Quality, Security Act established outsourcing facilities as a category of compounds in 2013. The FDA inspects these facilities according to a risk-based schedule that is subject to an increase in quality standards.
Outsourcing facilities are a category of compounds established in 2013 by the Drug Quality and Security Act. Pharmacy state boards, the FDA, and other various entities inspect compound drug facilities. Primarily, it is the responsibility of state boards of pharmacies for the daily oversight of licensed pharmacies not registered with the FDA as outsourcing facilities.
The FDA conducts for-cause inspections and surveillance of state-licensed pharmacies not registered as outsourcing facilities. However, outsourcing facilities registered with the FDA are generally overseen and inspected by the FDA according to a risk-based schedule under section 503B.
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Quality requirements and standards set for compounded drugs differ according to the setting where compounding occurs.
Drugs compounded in such outsourcing facilities are subject to the current good manufacturing practice (CGMP) requirements.
By contrast, drugs compounded in a federal facility or state-licensed pharmacy, by a licensed pharmacist or physician, are exempt from CGMP compliance requirements under the conditions of the FD&C Act, section 503A. There may be less stringent quality state law or policy standards set, which differ from state to state.
However, other federal requirements apply regardless of where compounding takes place, whether in an outsourcing facility, a physician’s office, or a pharmacy. These standards require that drugs are not to be packed, prepared, or held under unsanitary conditions.
Compounded Drugs are not Approved by FDA
The FDA does not approve of compounded drugs. Meaning they did not verify the drugs are effective or safe to take nor did they check the manufacturer of the drugs for quality assurance before marketing the drugs. Thus, health professionals and consumers rely on the FDA to check and approve drugs for quality, safety, and effectiveness
While compounding drugs may meet the medical needs of patients, they don’t have the assurance of quality, safety, and effectiveness as those that are FDA-approved. In addition, if compound medication kits are used unnecessarily, they could potentially expose patients to serious health risks. Moreover, incorrect compounding, such as contamination or adding too much of an active ingredient can lead to serious issues that can result in patient injury and/or death.
Hazards and Risks Associated with Compounding Drugs
During many compounding facility inspections, the FDA has observed various troubling conditions that can be very hazardous, including pet beds close to sterile compounding areas, toaster ovens being used for sterilization purposes, and staff handling sterile items without skin coverings, which can shed bacteria and particles, among other things. Unsanitary conditions like these — when handling compound drugs — can result in patient harm, especially if the compounder engages in non-specific, large scale compounding and distribution.
Many states don’t have the resources needed to adequately oversee such compounding and the FDA may not always be aware of who the compounders are.
The 2012 fungal meningitis outbreak
The most serious outbreak that ever took place in the United States associated with contaminated compound drugs, happened in October 2012, in Massachusetts when a pharmacy shipped compounded drugs throughout the country that were contaminated with fungus, which was injected into approximately 14,000 patients’ joints and spines. Over 750 people in 20 different states developed fungal infections, and over 60 people died.
This fungal meningitis outbreak wasn’t an isolated event, but it was the most serious outbreak in the history of adverse events that were associated with mislabeled, contaminated, super potent, and/or poor quality compounded drugs.
Nevertheless, since the 2012 fungal meningitis outbreak event occurred, there were many other serious adverse occurrences linked to bad quality compounded drugs that resulted in not only infections but also deaths.
In many cases, the FDA is not always aware of such events associated with poor compound drugs since most compounders will not report adverse event incidents to them. The only way the FDA will find out about these occurrences is if a patient, health care provider, or state official voluntarily submits a report regarding the adverse event to notify them.
There are many verifiable cases where a patient may require that a compound drug be used, such as when the patient is unable to swallow a pill, and therefore, medication is compounded into a liquid form or in the case where a patient may be allergic to a certain dye the drug contains. However, compounded drugs are not inspected and approved by the FDA and can be contaminated, as some compounding services that make compounded drugs are unsanitary.