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Sterile Compounding Guidelines: Standards, Equipment and Contracting

Follow guidelines, choose contractors carefully to prevent contamination


Sterile pharmacy compounding

Pharmacy compounding, or preparing customized dosages for individual patients, often requires taking special precautions to ensure sterility.

Photo courtesy of the U.S. Food and Drug Administration

A fall 2012 outbreak of fungal meningitis linked to contaminated epidural steroid injections compounded by a pharmacy in Massachusetts and distributed to at least 23 states prompted a recall of the products and warnings to hundreds of back and neck pain patients. Because several people who received unsafe methylprednisolone injections died, the case drew unflattering attention to all drug compounding. In fact, the chief science correspondent for NBC Nightly News all but said pharmacies that compound medications operate free from regulation.

The best rebuttal to such aspersions is not to list the federal laws, state rules and professional guidelines that dictate drug compounding standards and practices. Rather, pharmacy practitioners must commit to consistently compounding medications that are beneficial and safe.

USP Writes the Compounding Bible

The U.S. Pharmacopeial Convention sets the standards for customizing dosage forms and products for individual patients. The fullest list and links of these guidelines can be accessed by clicking the USP on Compounding link below.

Four things matter above all else when compounding drugs: including the correct active pharmaceutical ingredients, mixing in the appropriate excipients and solvents, preparing the correct dose and keeping contaminants out of the product. The most relevant set of guidelines for accomplishing the fourth goal is USP 797 "Pharmaceutical Compounding -- Sterile Preparations."

Reading, understanding and implementing USP 797 is a bit like eating an elephant. You cannot do it all it once, and you may not want to do it at all. One essential thing every pharmacy practitioner must know about the sterile compounding guidelines is that they detail the equipment, hygienic procedures and product testing schedules and methods pharmacists and pharmacy technicians should follow to ensure that bacteria, viruses, particulates and fungi do not enter compounded preparations.

Another key fact about USP 797, as noted in an invaluable FAQ maintained by the Society of Nuclear Medicine, is that the guidelines technically have the force of law and can be enforced by the U.S. Food and Drug Administration under the agency's authority to regulate the manufacture of drug products. The Joint Commission has at times planned to make USP 797 compliance a factor in accrediting health care organizations where sterile compounding is done, but it has yet to hold pharmacies and laboratories strictly to the standards.

Have the Right Tools and Procedures

The first step toward USP 797 compliance is making sure you have the right tools and procedures for the job. The guidelines specify different levels of sterility and safety requirements for certain preparations. As pharmacies move up the scale of potentially contaminable and dangerous compounds, the types of equipment and materials handling processes become more complex and costly.

Maintaining sterility when compounding begins with ensuring basic hygiene and cleanliness. Washing hand, wearing gloves, using masks and hair covers and cleaning all surfaces and implements with bleach, alcohol or high heat are required.

Beyond that, and depending on which preparations they compound, pharmacies will need a range of laminar airflow laboratory hoods, biological containment chambers, nuclear materials glove boxes and clean rooms. The Pharmaceutics and Compounding Laboratory at the University of North Carolina Eshelman School of Pharmacy offers good introductions to these devices and their uses here and here.

Storing compounded drug products requires having refrigerators and cabinets with air circulation and humidity controls. Conducting regular visual inspections and chemical and biological assays is also necessary to ensure the preparations remain free of contaminants and retain their effectiveness. Tools needed to do those analyses range from microscopes to high performance liquid chromatographs, and the schedule varies by product type, as spelled out in USP 797.

Ensure Contract Compounders Use Best Practices

Pharmacies that find fully complying with USP 797 too expensive or unnecessary to meet most of their patients' needs often contract out compounding services. Choosing a contractor carefully is essential, though.

Considerations to take, as spelled out by the American Society of Health-System Pharmacists in its Guidelines on Outsourcing Sterile Compounding Services, include the following:

  • Do you have the staff expertise, time and equipment to do necessary compounding in house?
  • Does a potential contractor have a strong track record of meeting other clients' demands for quality, sterility and on-time and on-price delivery?
  • Can you confirm that a potential contractor complies with USP 797 and other compounding guidelines?
  • Does a signed contract spell out processes for ensuring performance and enforcing provisions?
  • What is the cost?

Listing "cost" last signifies that meeting patients’ medication needs while ensuring their safety should always take precedence.

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