What is compounding?

Pharmacy compounding, or compounding, is the practice of specially mixing or altering prescription medicines to meet the specific needs of an individual patient.¹ The practice of compounding has traditionally been characterized by the consent and cooperation of the physician, patient, and pharmacist, often referred to as the triad of care. Pharmacies may legally compound medicine only for identified individual patients upon receipt of a valid, unsolicited prescription.²

Compounding is regulated by state boards of pharmacy, whereas pharmacy manufacturing is regulated by the Food and Drug Administration (FDA). Although the line between pharmacy compounding and pharmacy manufacturing is not always clear cut, the American Public Health Association (APHA) states, “The fundamental difference between compounding and manufacturing, and the key element in making any such distinction, is the existence of a pharmacist/prescriber/patient relationship.”

Some legitimate reasons for compounding include²:

• The patient is allergic to the standard version of the drug
• The needed or requested dosage is not available in the standard version of the drug
• The patient is unable to swallow the standard version of the drug
• The drug taste prevents the patient from taking the drug, for example, pediatric patients

AstraZeneca supports and encourages the practice of compounding when it is done properly and with the full consent and knowledge of the triad of care. However, due to improper and illegal execution of the practice that has been cited by the Food and Drug Administration (FDA), AstraZeneca has established www.knowthedifference.org to educate and inform members within the triad of care to increase awareness of the practice and the potential risks to the physician and patient.

When does compounding become pharmacy manufacturing?

Some pharmacies and home health care companies characterize compounded products as generic versions of products; they are not. The FDA has never reviewed nor approved a generic equivalent of PULMICORT RESPULES.

The U.S. Department of Health and Human Services has identified several mitigating factors that make compounding illegal. The following circumstances exceed the boundaries of traditional compounding and may warrant FDA enforcement action:

• Violating the triad of care¹
  • Medication is compounded without the prescribing physician’s specific authorization⁴
• Manufacturing or compounding mass quantities of drug products before receipt of a prescription and intended for large numbers of patients¹
• Compounding commercially available drug products¹
• Receiving, storing, or using drug components that do not meet compendia requirements (eg, sterility)¹

* Not subject to FDA oversight

NEXT: What are some potential risks of pharmacy manufacturing?