Medilab Compounding
Compounded drugs can be defined as medication that is customized to meet the clinical needs of patients, which cannot be otherwise met through commercially available products that are approved by the FDA. Take for example a patient that has trouble swallowing solid pills. He/she can approach a compounding pharmacy to make a liquid version of the same drug for some much-needed comfort.
Compounding has existed ever since the dawn of modern medicine. Pharmacists have always modified medications when needed and that remains in effect even today. Compounding has evolved drastically over the years. We have compounders today that produce large quantities of drugs that traditional pharmacies do not offer to healthcare providers.
Epidural Analgesics or preservative-free sterile products are just a few good examples of compounded drugs. Another thing that has changed over the years is the way compounded drugs have been regulated. As compounding businesses expanded, there were tragic incidents that led to the nationwide outbreak of fungal meningitis. Fortunately, lawmakers at the state and federal levels quickly swooped in to protect patient safety.
In 2013, the bipartisan Drug Quality and Security Act was passed to facilitate access to safe compounded medications for patients who need them. At the same time, it aimed to protect patients from the risk of drugs that were made under dangerous conditions. The law granted FDA the privilege of producing bulk supplies of non-patient-specific drugs. These facilities are required to follow stringent protocols to prevent the contamination of drugs being produced.

Which Entities are allowed to Compound Drugs?

Typically, businesses that produce commercially available drugs must obtain an FDA approval and comply with the labeling as well as quality requirements. Businesses that specialize in making compounded drugs, on the other hand, such as compounding pharmacies are exempt from such laws.
According to the DQSA, two categories of drugs can be manufactured outside the FDA’s approval process:

  • Patient-Specific Compounded Drugs Made by Traditional Compounders. This includes pharmacists and physicians who create custom drugs.
  • Stock supplies of compounded drugs manufactured. This includes outsourcing facilities that produce compounded drugs for hospitals and doctors.
A company that doesn’t fit into any of the above two categories and doesn’t possess FDA approval is not allowed to sell an unapproved drug. They are in clear violation of the federal law if they are at all engaging in such a practice.

Which Drugs Can Be Compounded?

The FDCA has a clearly defined list of active drug ingredients that compounders can use to create new compounded drugs. These ingredients are known as bulk drug substances. They must fall into any of the following categories:

  • Substances that are part of FDA-approved products.
  • Substances for which the USP (United States Pharmacopeia) has set quality and strength standards.
  • Substances are included on the list of ingredients FDA approved by regulation.
According to the section 503B dictated by the FDCA, outsourcing facilities can only use ingredients that are found on either of the two lists maintained by the FDA mentioned below:

  • The first includes identifying bulk drug substances for which there is clinical demand that cannot be met by current FDA-approved products.
  • The second includes identifying FDA-approved drugs that are in shortage.
The bulk drug substances must also comply with the USP standards that have been established for the drug. The substance must also be manufactured in an FDA-approved establishment. Compounders are allowed to use ingredients that are integral parts of FDA-approved drugs. However, they are not allowed to create large quantities of products that are essentially copied versions of the original FDA-approved drug.
Through all of these restrictions, it is ensured that entities that indulge in the manufacturing of compounded drugs are not able to violate laws and endanger patients.

How DQSA is Ensuring Patient Safety with Prescription Requirements

To prevent patient harm, it is required that compounded drugs be free from contamination. As such, they should include ingredients in the right amount. This will largely depend on the compounder and the safety measures they follow. This is why the DQSA created a specific category of businesses that are allowed to compound drugs and distribute them.
Outsourcing facilities that develop drugs in bulk are required to first obtain FDA approval. They must comply with federal quality standards and other similar conditions. The compounders that fail to meet these requirements need a prescription before they can dispense a drug. A clear line has been established that distinguishes traditional compounders from outsourcing facilities. The line we are referring to is the prescription requirement that all traditional compounders must fulfill.
The DQSA is making sure patient safety is upheld by preventing traditional compounders from dispensing drugs without prescription. The prescription requirements ensure that stock supplies of drugs that possess greater security threats adhere to expected safety standards.


We’ve come a long way from unsafe practices when it comes to compounded medications. With a reputed pharmacy in charge of customizing your medication, you can rest easy knowing appropriate safety measures are being taken in adherence to established policies and regulations. Medilab Compounding is one such pharmacy that prides itself in offering quality compounding services that change the taste, dosage, and form of medication so it is easier for you to take them.
We recommend you give us a call to learn more about how we can help you.