Compounding: The Definition

The preparation, mixing, assembling, packaging, or labeling of drugs or device as the result of a practitioner's prescription drug order or initiative based on the practitioner, patient, pharmacist relationship in the course of professional practice, or for the purpose of or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. A customized medication is prepared by a pharmacist according to a doctor's specification to meet an individual patient need. Pharmacists make medications from scratch using raw chemicals, powders and devices.

Compounding : The History

Compounding is inherent in pharmacy practice. It is the birthright of the profession. The practice of preparing medications dates back to biblical times.

In modern times, the roles and responsibilities of pharmacists have coincided with the industrial revolution and the changes in health care. In the 1930s and 1940s, approximately 60 percent of all medications were compounded. During the 1950s and 1960s, with the advent of manufacturing, compounding decreased. The role of pharmacists went from that of an apothecary or chemist, preparing medications from scratch, to that of a dispenser of the manufactured dosage form.

Today more and more, physicians and patients are again realizing the benefits of individualized or unique dosage forms for specific patient  needs.

Compounding: The Pharmacist

The compounding pharmacist is a problem-solver in the community, working with patients and physicians to gain positive outcomes.

No other health care professional has studied chemical compatibilities and can prepare dosage forms. Even when modern scientific technologies have produced new chemical entities, the ability of a pharmacist to combine one or more chemicals into a new preparation or process the existing dosage form into one that is better suited to the patient's needs, has remained the domain of the pharmacist. Because every patient is different and has different needs, pharmacy compounding  will always be a practice essential  to the profession.

Compounding: The Need

The basis of the profession of pharmacists has been the patient-physician-pharmacist relationship. Through this relationship, patients may need a compound medication. There a number of reasons  to compound medications, including but not limited to:

Medications that are not commercially available:

Manufacturers must be assured that there will be a return on their investment when entering the market place with a drug product. Therefore, there are limited chemical forms, dosage forms, strengths, flavors and packaging that are available for the physician to prescribe and the pharmacist to dispense. Compounding allows the physician to prescribe a custom-tailored medication that is not available commercially.

Medications that are not stable:

A pharmacist can prepare small qualities of the prescription more frequently to ensure stability of the product for its intended use.

Altered commercially available medications:

Physicians prescribe a commercially available medication in a different dosage form to meet a specific patient need and ensure patient compliance. For example, a patient may be allergic to a preservative or dye in a manufactured product. The compounding pharmacist can prepare a dye-free or preservative-free dosage form. Some patients have difficulty swallowing a capsule and require a troche or lozenge. Many pediatric patients are non-complaint because their medications are bitter, but become compliant when the medication is flavored and sweetened to their liking.

Compounding: Education & Regulation

Pharmacy schools teach students to compound, and state boards of pharmacy test, license and regulate this tradition of practice in the profession. Recently, the National Association of Boards of Pharmacy have distributed " Good Compounding Practice Appliance to the State-Licensed Pharmacies" and  the United States Pharmacopoeia Convention, Inc. drafted " Pharmacy Compounding Practices." These two documents mark the importance of compounding as part of quality medical care in the United States and establish standards for the entire profession of pharmacy.