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USP CHAPTER 797 COMPLIANCE

Why is it important to comply with the requirements of USP <797>? Reasons for compliance include patient safety, economics, publicity, and regulations.

Patient Safety

Improperly compounded CSPs can injure and kill patients. Since 1990, the Food and Drug Administration (FDA) has documented more than 55 quality problems associated with compounded preparations. Many of these problems ultimately led to recalls, patient injury, and even death. USP <797> helps you develop good compounding practices and quality systems, which will ensure the health and well being of your patients.

Economics

In the future, liability underwriters could

• Demand evidence of compliance with USP <797> as a condition of continued coverage
• Increase premiums for facilities that prepare CSPs
• Drop liability coverage altogether for facilities that prepare CSPs

Another factor to consider is that accreditation organizations will be surveying pharmacies for compliance with USP <797>. Failure to comply could lead to a loss of accreditation, which would affect your ability to bill and collect from patients. In addition, state boards of pharmacy are citing pharmacies for failure to comply with regulations, and are assessing financial penalties.

A final financial consideration is lawsuits. Lawyers have successfully quoted information from USP <797> as evidence of standards of practice during lawsuits.

Publicity

Compounding errors and problems lead to unfavorable media coverage, causing patients and regulators to lose their trust in pharmacists. As a result, authorities could restrict compounding to specialty pharmacies and board-certified pharmacists.

Regulations

USP <797> is a requirement, and is part of the Federal Food, Drug, and Cosmetic Act. Attorneys, boards of pharmacy, accreditation organizations, and the FDA can use these requirements during inspections, surveys, and enforcement actions. Up to now, the FDA has been lenient during routine inspections, but will intervene if patients are harmed or die because of CSP errors.

As a further point, many states have adopted standards that are even more stringent than USP <797>. Pharmacists should contact their boards of pharmacy for information about state requirements and enforcement.