Pharmaceutical compounding is the science responsible for the creation of customized medication. Compounded medications are created by combining individual ingredients in the exact strength and dosage form required by the patient and their own unique needs.
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Frequently Asked Questions about Compounding Medicine
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 (see question below on legal oversight of compounding versus manufacturing). 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.
WHAT IS A COMPOUNDING PHARMACY?
While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently. The preparations offered by these compounding pharmacies can be nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for the eye, or injection into body tissues or the blood).
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers.
Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and non-sterile dosage forms. Compounding also takes place in hospital pharmacies and at other health care facilities.