FAQsThis is a knowledge base referencing questions others have had.
What is compounding, and why is it necessary?
Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued. The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”
Following are a few examples of how a compounding pharmacist can customize medications based upon a doctor’s prescription to meet a patient’s needs:
- Customize strength or dosage.
- Flavor a medication (to make it more palatable for a child or a pet).
- Reformulate the drug to exclude an unwanted, nonessential ingredient, such as lactose, gluten, or a dye to which a patient is allergic.
- Change the form of the medication for patients who, for example, have difficulty swallowing or experience stomach upset when taking oral medication.
Compounding pharmacists can put drugs into specially flavored liquids, topical creams, transdermal gels, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not include making copies of commercially available drug products, as this is not allowed by law.
How is pharmaceutical compounding different from drug manufacturing?
Traditional compounding is the preparation of a medication to meet the prescriber’s exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient.
Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy.
Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These products are sold to pharmacies, health care practitioners, or others who are authorized under state and federal law to resell them.
Does a Compounding Pharmacist receive special training?
Compounding is a central activity to the practice of pharmacy. Pharmacists are taught in pharmacy school how to properly compound medications, and many states test pharmacists’ compounding knowledge and skills before issuing them a license.
Pharmacists who practice in the 7,500 pharmacies that specialize in compounding services have generally had advanced training in compounding after they graduated from pharmacy school. No state currently requires a particular type of training, and no nationally recognized specialty exists for pharmaceutical compounding. Specialized training in pharmacy compounding processes is available through several of the active pharmaceutical ingredient (API) suppliers serving the needs of the compounding pharmacy community.