Not every medication comes in the right dose, form, or combination for every patient. Some people have allergies to certain ingredients, while others have difficulty swallowing pills or require a dosage that is not commercially available.
This is where pharmaceutical compounding may help.
Compounding is the process of combining, mixing, or altering ingredients to create a medication that meets an individual patient’s medical needs.
At Compounding Pharmacy of America, our pharmacists work with licensed healthcare providers to prepare customized medications when an appropriate commercially available option cannot meet a patient’s specific needs.
Understanding how compounding works can help patients and providers make more informed treatment decisions.
A compounded medication is prepared for a specific medical need rather than mass-produced in a standard formulation.
Unlike commercially manufactured medications, which generally come in predetermined strengths and dosage forms, compounded medications may be customized according to a healthcare provider’s prescription.
Examples include:
Compounding does not mean creating an entirely new drug. In many cases, it involves adjusting an existing medication’s ingredients, strength, or dosage form to address a specific patient need.
Importantly, compounded medications are not FDA-approved and should be considered when an FDA-approved option cannot appropriately meet the patient’s medical needs.
Compounding involves collaboration between the patient, prescriber, and compounding pharmacist.
A licensed healthcare provider evaluates the patient’s health history, treatment requirements, and available medication options.
If an FDA-approved medication cannot appropriately meet the patient’s needs, the provider may consider a compounded formulation.
The prescriber identifies the medication, desired strength, dosage form, and other relevant instructions.
The pharmacist reviews the prescription and determines whether the preparation can be compounded appropriately under applicable requirements.
A trained compounding professional prepares the medication using appropriate ingredients, equipment, procedures, and quality controls.
The preparation must follow applicable federal and state requirements and relevant compounding standards.
The pharmacist provides instructions about administration, storage, expiration or beyond-use dating, and precautions.
Patients should follow their prescriber’s directions and contact their pharmacist with questions about the medication.
Compounding can serve an important role when commercially available medications do not meet a patient’s specific medical needs.
Some patients require a medication strength that is not commercially available.
A compounding pharmacist may be able to prepare the prescribed strength when clinically appropriate and legally permitted.
Not everyone can comfortably take tablets or capsules.
Depending on the medication, compounding may allow an alternative form, such as a liquid, topical cream, or gel.
Some medications contain dyes, preservatives, or other inactive ingredients that certain patients cannot tolerate.
A compounded formulation may allow the pharmacist to exclude a problematic ingredient when an appropriate alternative is unavailable.
Children and older adults sometimes have unique dosing or administration requirements.
For example, a child may need a liquid preparation when the prescribed medication is only commercially available as a tablet.
In certain circumstances, compounding may help address an unmet need when a commercially manufactured medication is unavailable.
However, federal restrictions apply to compounding copies of commercially available medications, including special requirements related to drug shortages.
Both traditional and compounding pharmacies dispense medications and provide professional pharmaceutical care. The main difference is how medications are prepared.
Many traditional pharmacies also perform some compounding. Specialized compounding pharmacies have additional facilities, equipment, and training to prepare certain customized formulations.etur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
No. Compounded medications are not FDA-approved.
The FDA does not review individual compounded medications for safety, effectiveness, or quality before they are marketed.
This is an important distinction between compounded medications and FDA-approved prescription drugs.
Compounded medications can fill legitimate medical needs, but they also carry risks. Improper preparation may result in contamination, incorrect ingredient amounts, or other quality problems.
Patients should discuss the potential benefits and risks with their healthcare provider before using a compounded medication.
For more information, see the FDA’s guide to compounding and regulatory oversight.
Compounding pharmacies operate under federal and state laws designed to protect patients.
State pharmacy boards regulate licensed pharmacies and pharmacists. They oversee professional licensing and compliance with applicable state requirements.
The FDA has federal regulatory authority over drug compounding.
Section 503A of the Federal Food, Drug, and Cosmetic Act establishes conditions under which eligible compounded medications may qualify for exemptions from certain federal drug requirements.
Additional provisions apply to registered outsourcing facilities operating under Section 503B.
The United States Pharmacopeia develops standards used to support medication quality and safe compounding practices.
Relevant standards include:
These standards address important aspects of compounding, including preparation procedures, contamination prevention, and personnel safety.
Learn more through the United States Pharmacopeia.
Compounding may be appropriate for patients whose specific medical needs cannot be met by an available FDA-approved medication.
Examples include:
Not every patient needs a compounded medication. FDA-approved medications are generally preferred when they can appropriately meet the patient’s needs.
Compounding Pharmacy of America works with patients and healthcare providers to address individualized prescription needs.
Our compounding services cover a range of specialties, including hormone therapy, dermatology, pediatric health, pain management, and other areas of patient care.
Explore our Compounding Pharmacy Services to learn more about the types of medications and formulations we support.
We also provide resources for new patients and healthcare prescribers interested in learning about our pharmacy services.
Yes, in appropriate circumstances. A healthcare provider may prescribe a compounded medication when a child needs a particular dose or dosage form that is not commercially available.
Understanding your medication options is an important part of making informed healthcare decisions.
If a commercially available prescription cannot meet your medical needs, talk with your healthcare provider about whether pharmaceutical compounding may be appropriate.
Medical Disclaimer: This content is intended for educational purposes only and does not replace professional medical advice. Consult your healthcare provider to determine whether a compounded medication is appropriate for your individual medical needs.
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Compounding Pharmacy of America is nationally accredited by the Pharmacy Compounding Accreditation Board (PCAB) and LegitScript Certified, which means that we follow the industry’s best practices and meet the highest national standards for organizations in our field.
