Have you ever heard of pharmacy compounding? Do you know what compound drugs are? Well, if the answer to either is no, you’re in the right place to change that.
Compounding is a process by which pharmaceutical drugs are developed to suit the individual needs of a patient. It’s a legal process, but it is not approved by the FDA (not necessarily a bad thing).
In this article, we will cover the most frequently asked questions about pharmacy compounding.
So if you’d like to know more and potentially get custom medications to suit your health needs, keep reading.
Compounding: What Is It?
As mentioned earlier, compounding is the process by which pharmaceutical drugs are created by licensed pharmacists. These drugs are developed to meet the individual needs of a patient. Specifically, when a commercial drug cannot meet those needs.
For instance, a patient might not be able to tolerate the content of the drug. As well as the exact formula might not be available, or they might require a drug that is no longer available. The US Pharmacopeia Convention defines compounding as altering, mixing, assembling, packaging, preparing. And labeling of a device, drug-delivery device, or drug, as well as medication order.
Here are some other examples of how compounding pharmacists can customize a medication to suit the needs of a patient:
- Develop custom dosage and strength
- Change medication form to help those who cannot take oral medication or have trouble swallowing pills
- Flavor the drug to make it palatable
- Reformulate to exempt unnecessary, non-essential ingredients
Compounding pharmacists can add medication to topical creams, suppositories, liquids, gels. And many other forms that can make the experience tailored for each individual. Compounding does not cover the recreation of commercially available drugs. Because that is against the law.
Do Compounding Pharmacists Have Licenses?
Compounding is an important function of pharmacy. Pharmacists are subject to education on how to compound medications. Many states have examinations in place to test their skills and knowledge before licensing them.
Pharmacists who practice in compounding pharmacies have advanced training. In most cases, they have acquired after pharmacy school. No state requires specific training. And there is no national specialty existing for compounding.
However, specialized training is available with various pharmaceutical ingredient suppliers. Thus being able to learn how to properly serve the needs of the compounding community.
How Can Somebody Know If A Drug Is Compounded?
The first and only thing to do is to ask. A patient can receive compounding drugs from a local pharmacy or a special compounding facility. These compounded drugs can also be administered by health professionals in medical offices and clinics.
Always ask before served with medication or administered with it, whether it came from a drug company or created in a compounding pharmacy.
A widely recognized practice of compounded drugs is to have them labeled with all of the necessary information. Specifically denoting their “compounding” aspect.
If a prescription asks for a compounded drug, a patient can ask about its accreditation. A list of accredited pharmacies can be found for each state on the Pharmacy Compounding Accreditation Board website.
Who Inspects Compounding Facilities?
When it comes to inspecting compounding facilities, many entities perform such work. Including the FDA and state boards.
Generally, state boards have the primary obligation for oversight of state-licensed compounding pharmacies. Specifically, those that are not registered with the FDA.
FDA does not perform for-cause surveillance or inspections of such pharmacies. That’s because they are not registered as an outsourcing facility.
Facilities that choose to register as one under section 503B can be primarily reviewed by the FDA, and assessed based on risk.
What Quality Standards Apply?
Quality requirements will differ for all compounding drugs, especially depending on the setting in which they are developed. Compounded drugs in outsourcing facilities are subject to Current Good Manufacturing Practice.
By contrast, compounded drugs by a pharmacist in a pharmacy or federal facility are exempt from CGMP requirements based on a section of 503A from the FD&C Act. These facilities are subject to lesser quality standards that are set in the policy. These standards vary in each state.
Regardless of where the compounding is happening, whether in a facility or pharmacy, other federal requirements are applicable. Including the requirement for the drugs to not be packed, held under, or prepared in unsanitary conditions.
Are Compound Drugs FDA-Approved?
Compound drugs are not approved by the FDA. This only means that the FDA has not verified the effectiveness or safety of these drugs.
Health professionals and consumers rely on drug approval for effective, quality, and verification of safety. Compounded drugs also lack a review of manufacturing quality before they subject to marketing.
In any case, this is because of the simple fact that compounded drugs are most often customized to the needs of the patient. And cannot be approved for the reason that FDA approval can take many years. This removes the very benefit of compounded drugs being available at any time.
Compounded for You
Now that you know what compound drugs are, and you have witnessed the answers to the most frequently asked questions.
You can finally determine if you’d like to try them out for your own health. In many cases, individuals are referred to as compounded drugs by their physicians. That’s mostly because commercial drugs are simply not doing their job.
And that’s that for this article. If you’d like to check out some similar content, feel free to gauge through our other health-related articles on the sidebar or via the filtered categories.