A compounding pharmacy prepares a medication for an individual patient based on a prescription, rather than dispensing a mass-produced product. In the United States, compounding pharmacies are overseen mainly by state boards of pharmacy, with federal rules from the FDA setting the outer limits. Below, we explain what compounding is, how it is regulated, and what it means for patients who are prescribed a compounded medication.
What compounding means
Compounding is the practice of combining, mixing or adjusting ingredients to create a medication tailored to one patient. A pharmacist might compound a medication when a commercially available product does not fit a patient's needs. Common reasons include:
- A patient needs a different form, such as a liquid, cream or topical solution instead of a tablet
- A patient is sensitive to an inactive ingredient, such as a dye, preservative or fragrance, found in the commercial version
- A prescriber wants to combine more than one ingredient into a single preparation
- A commercial product is not available in the form or base the prescriber wants
Compounding is not new. Before large-scale drug manufacturing, most medicines were prepared by pharmacists. Today it remains a regular part of pharmacy practice in areas such as dermatology, hormone therapy, pediatrics and veterinary care.
How compounded medications differ from FDA-approved drugs
An FDA-approved drug has gone through a formal review in which the manufacturer submits data on safety, effectiveness and manufacturing quality. Once approved, that exact product is made in large batches to a fixed formula.
Compounded medications do not go through that premarket approval process. Compounded medications are not FDA-approved. That means the FDA has not reviewed a specific compounded preparation for safety, effectiveness or quality before it reaches a patient. Instead, oversight focuses on the pharmacy itself: who may compound, under what conditions, and to what standards.
This difference is important to understand, and it is one reason a prescriber and pharmacist should explain why a compounded option is being considered for a particular patient.
The two main types of compounding pharmacies
Federal law describes two pathways for compounding, often referred to by their sections of the Federal Food, Drug, and Cosmetic Act.
503A pharmacies
These are traditional compounding pharmacies. They prepare medications based on a valid prescription for an individual, identified patient. They are licensed and inspected primarily by the state board of pharmacy in the state where they operate, and they must also meet the licensing requirements of each state they ship to. Most prescriptions compounded for a single patient come from this type of pharmacy.
503B outsourcing facilities
Outsourcing facilities are a separate category created by federal law in 2013. They can compound larger quantities, sometimes without a patient-specific prescription, typically for hospitals and clinics. They register with the FDA, are subject to FDA inspection, and must follow current good manufacturing practice requirements.
Who regulates compounding pharmacies
Several layers of oversight apply to pharmacies that compound:
- State boards of pharmacy. Boards license pharmacies and pharmacists, set state rules, and conduct inspections. A pharmacy that ships medications to patients in other states usually needs a license or registration in each of those states as well.
- The FDA. Federal law sets conditions compounders must meet, including rules on which ingredients may be used and limits on copying commercially available drugs. The FDA can inspect pharmacies and act when it finds problems.
- USP standards. The United States Pharmacopeia publishes standards for compounding, including chapters for nonsterile preparations (such as creams and topical solutions) and sterile preparations (such as injections). Many states require pharmacies to follow these standards. They cover areas like facility cleanliness, staff training, ingredient quality, labeling and beyond-use dating.
Pharmacists themselves are licensed professionals who must meet education, examination and continuing education requirements in each state where they practice.
What a prescription for a compounded medication involves
For a traditional compounded medication, the process usually looks like this:
- A licensed prescriber evaluates the patient and decides whether a medication is appropriate.
- If so, the prescriber writes a prescription specifying the ingredients and form.
- A licensed pharmacy reviews the prescription, prepares the medication following its procedures and applicable standards, labels it for that patient, and dispenses it.
- The patient receives instructions and knows how to reach the care team with questions.
At Prescribed Essence, the steps follow the same pattern. A patient completes an online intake and uploads photos. A licensed provider decides whether treatment is appropriate. If treatment is prescribed, a licensed pharmacy prepares a personalized compounded formula for that patient and ships it. You can read more about the first step in our article on how a telehealth consultation works, and about what follows in shipping, follow-up and ongoing care.
Why compounding is used in hair loss care
Hair loss treatment is one area where compounding is commonly used. A prescriber may want a topical solution with a particular base, a preparation without certain inactive ingredients, or a combination of ingredients in one product rather than several separate ones. Our guide to compounded hair loss treatment covers how this works in more detail, and our comparison of compounded and over-the-counter options explains how they differ.
Whether a compounded option makes sense is a medical decision. A licensed provider decides whether treatment is appropriate based on the patient's history, the likely cause of the hair changes, other medications and personal goals.
Questions to ask about a compounded medication
If you are prescribed a compounded medication by any provider, these questions can help you understand it:
- Why is a compounded version being recommended instead of a commercial product?
- Which pharmacy will prepare it, and is it licensed in my state?
- What ingredients does it contain, including inactive ingredients?
- How should it be stored, and what does the beyond-use date on the label mean?
- What side effects should I watch for, and who do I contact if I have one?
- How will my provider check in on how things are going?
A good pharmacy and care team will welcome these questions. Pharmacists are trained to counsel patients about their medications, and you can ask to speak with one.
Safety and reporting problems
Any medication, compounded or not, can cause side effects or reactions. If you notice something unexpected, such as irritation, a rash, dizziness or any symptom that concerns you, contact your prescriber or pharmacist. Seek urgent care for signs of a serious allergic reaction, such as swelling of the face or throat or difficulty breathing.
Patients and health professionals can also report problems with a compounded medication to the FDA through its MedWatch program, and concerns about a pharmacy can be reported to the state board of pharmacy.
The bottom line
A compounding pharmacy prepares medications for individual patients under state and federal rules and professional standards. Compounded medications are not FDA-approved, so it is reasonable to ask why one is being prescribed and who is preparing it. A licensed provider decides whether treatment is appropriate, and a licensed pharmacy prepares and dispenses what is prescribed.
If you would like a licensed provider to review your history and photos, you can start your online consultation.
Prescription required. A licensed provider decides whether treatment is appropriate. Compounded medications are prepared by a licensed pharmacy for an individual patient and are not FDA-approved. Individual results vary. Prescribed Essence currently serves patients in California, Colorado, Florida and New York.
