New England Compounding Center incident

Main article: New England Compounding Center meningitis outbreak

In October 2012, an outbreak of fungal meningitis was reported in the United States. The U.S. Centers for Disease Control and Prevention traced the outbreak to contaminated medication used for epidural steroid injections. The medication was packaged and marketed by the New England Compounding Center, a compounding pharmacy in Framingham, Massachusetts. On October 15, the FDA issued a warning that two more drugs, a steroid and a product used during heart surgery, may also have been contaminated. The investigation also includes fungal infections associated with injections in a peripheral joint space, such as a knee, shoulder or ankle.^[7]

Roles During research and development

Pharmaceutical compounding is a branch of pharmacy that continues to play the crucial role of drug development. Compounding pharmacists and medicinal chemists develop and test combinations of active pharmaceuticals and delivery systems for new pharmaceutical formulations so that the active ingredients are effective, stable, easy to use, and acceptable to patients. However, for actual clinical trials, production of drug products is generally considered "manufacturing" because "compounding" is typically defined as being for small batch or single individual patient production only.

Patients with unique or unusual medication needs

Physicians may prescribe an individually compounded medication for a patient with an unusual health need. This allows the physician to tailor a prescription to each individual. Compounding preparations are especially prevalent for:

• Patients requiring limited dosage strengths, such as a very small dose for infants

• Patients requiring a different formulation, such as turning a pill into a liquid or transdermal gel for people who cannot swallow pills due to disability

• Patients requiring an allergen-free medication, such as one without gluten or colored dyes

• Patients who absorb or excrete medications abnormally^[8]

• Patients who need drugs that have been discontinued by pharmaceutical manufacturers because of low profitability

• Patients facing a supply shortage of their normal drug^[9][10]

• Children who want flavored additives in liquid drugs, usually so that the medication tastes like candy or fruit

• Veterinary medicine, for a change in dose, change to a more easily-administered form (such as from a pill to a liquid or transdermal gel), or to add a flavor more palatable to the animal. In the United States, compounded veterinary medicine must meet the standards set forth in the Animal Medical Drug Use Clarification Act (AMDUCA)^[8][11]

• Many types of bioidentical hormone replacement therapy^[12]

Personalized medicine and polypharmacy

While the regulatory boundaries are not always clear (see "Regulation"), there is general acceptance of the need for physicians to have wide discretion to prescribe customized drug products containing unique drug/dosage combinations specifically for individual patients. While very few pharmacies offer such service, they do exist and can usually be used via mail-order with sufficient notice and planning.^[13]