SAFE AND EFFECTIVE COMPOUNDING

To affirm that compounding of medications, when done to meet immediate or anticipatory patient needs, is part of the practice of pharmacy and is not manufacturing; further,

To support preferential use of commercially manufactured products in ready-to-administer dosage forms where barriers do not exist; further,

To encourage the pharmacy workforce members who compound medications to use only drug substances that have been manufactured in Food and Drug Administration-registered facilities and that meet official United States Pharmacopeia (USP) compendial requirements; further,

To advocate that all compounding activities meet applicable USP standards and federal and state regulations; further,

To support the principle that the pharmacy workforce be adequately trained and have sufficient facilities, equipment, automation, and technology to ensure the quality of compounded medications; further,

To encourage USP to develop compounded preparation monographs for commonly compounded preparations; further,

To educate prescribers, other healthcare professionals, and patients about the potential risks associated with the use of compounded preparations.

Rationale

The practice of compounding has evolved along with the profession of pharmacy and it remains an essential component of patient care and pharmacy practice. With advances in pharmaceutical manufacturing, the need for preparation of individualized medications based on a prescription or medication order has decreased but not disappeared. Extemporaneous compounding of medications, when done to meet immediate or anticipatory patient needs, will likely always be an essential part of the practice of pharmacy, and cannot be replaced by any manufacturing model currently envisioned. Commercially and readily available drug products in the form necessary to meet patient needs should always be preferred to extemporaneously compounded alternatives, except when excipients or other components render the commercially available product clinically inappropriate for an individual patient. When extemporaneous compounding is required, it should meet strict requirements to protect patients from receiving substandard or poor-quality medications that pose a safety risk to their health and well-being. In particular, extemporaneously compounded sterile preparations must ensure highest quality. Extemporaneous compounding should be performed only using drug substances that have been manufactured in Food and Drug Administration-registered facilities and that meet official United States Pharmacopeia (USP) compendial requirements. Such compounding should only be performed by adequately trained pharmacists and pharmacy technicians, in facilities and with equipment that meet technical and professional standards to ensure the quality and integrity of the compounded medication, and in accordance with USP standards and other applicable federal and state regulations. To facilitate such a high level of compounding, USP should develop drug monographs for commonly compounded preparations. ASHP and its members have always devoted a great deal of effort to promoting safe extemporaneous compounding, through education of pharmacists and pharmacy technicians, publication of best practices, and advocacy, recognizing the inherent risks of any such endeavor. Pharmacists and pharmacy technicians have a responsibility to safely prepare and distribute compounded medications to meet the unique and customized therapeutic needs of their patients, and ASHP and pharmacists therefore have a responsibility to educate prescribers, other healthcare professionals, and patients about the potential risks associated with the use of extemporaneously compounded preparations.