USP Chapter <797> and Nuclear Medicine

Recently we have received questions from our customers about what effect USP Chapter <797> might have on hospital nuclear medicine departments. This page will answer some of those questions.

For background, the United States Pharmacopeia (USP) is a reference used by drug manufacturers and pharmacists that establishes standards for the preparation of prescription and over-the-counter medicines. Chapter <797> is a standard that pertains to the preparation of Compounded Sterile Preparations (CSPs) by all persons in all practice settings. Sterile radiopharmaceuticals prepared in a nuclear medicine department are subject to this standard. The latest revision of the standard became official and enforceable on June 1, 2008.

Enforcement of USP standards is usually done by the US Food and Drug Administration (FDA), state agencies, and accrediting agencies, such as the Joint Commission. The FDA, however, rarely gets involved in enforcement issues at the state level except in cases of injury, death, or complaint. The state agency in Texas with the most interest in enforcement of Chapter <797> is the Texas State Board of Pharmacy and it is unlikely to extend that interest beyond the practice of pharmacy by licensed pharmacists in permitted pharmacies.

The most likely source of enforcement action in a hospital nuclear medicine department is the Joint Commission, and its level of interest is undetermined at this point. The Joint Commission website states that compliance with Chapter <797> continues to be “regarded as significant” but the specifics are unclear. Of some interest is a revised accreditation requirement effective April 6, 2009 (MM.05.01.07) that requires in-house preparation of radiopharmaceuticals to be done by or under the supervision of a trained registered pharmacist or physician. Some believe that this revision may have the effect of leaving compliance with Chapter <797> in the hands of the supervising pharmacist or physician but that has yet to be established.

In a clinic setting, it appears that any enforcement action would come from the Texas Medical Board only if sterile preparations were prepared or altered on-site and an injury, death, or complaint occurred. Clinics using unit-doses only are not subject to the provisions of Chapter <797>, but the preparation of pharmacologic stress agents might fall under the scope of coverage of the standard.
The following will provide more details on the provisions of Chapter <797>. If you still have questions, please call Monty Ingram at our Tyler pharmacy at 903-592-8115.

USP Chapter <797> in the Nuclear Medicine Department or Clinic

The United States Pharmacopeia (USP) is an official, non-governmental, public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP sets standards for the quality, purity, strength, and consistency of these products critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe.

USP standards are enforceable by the US Food and Drug Administration and by various state agencies charged with protecting the public health.

USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations is one such standard. It sets out practices and conditions under which CSPs must be prepared to help ensure that such preparations are of high quality. The current revision of Chapter <797> became official and enforceable on June 1, 2008.

Diagnostics and radiopharmaceuticals that must be sterile when administered to patients are included in the list of preparations that are covered by Chapter <797>. The requirements of the Chapter do not apply, however, to unit-dose preparations that are administered to the patient without alteration or manipulation. The Chapter establishes three contamination categories for CSPs based primarily on the potential for microbial contamination during the compounding process, as well as an exemption from those categories for the on-site preparation of CSPs needed for emergency or immediate patient administration. These CSPs for immediate-use must be prepared according to six specific criteria in order to be exempt from the more stringent requirements of the Low-Risk Level CSPs. (See Immediate-Use CSP Preparation Criteria under the next heading).

If a nuclear medicine department or clinic that prepares CSPs on-site is in 100% compliance with the six requirements of the Immediate-Use exemption then the remainder of Chapter <797> does not apply. Less than 100% compliance, however, subjects the department to all of the provisions of the Chapter.

Immediate-Use CSP Preparation Criteria

Immediate-use CSPs are exempt from the requirements described for Low-Risk Level Compounded Sterile Preparations (CPSs) only when all of the following criteria are met:

1.  The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers’ original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solutions or administration container/device. For example, anti-neoplastics shall not be prepared as immediate-sue CSPs because they are hazardous drugs.
2.  Unless required for the preparation, the compounding procedure is a continuous process not exceed 1 hour.
3.  During preparation, aseptic technique is followed and, if not immediately administered, the finished CSP is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other CSPs, and direct contact of outside surfaces.
4.  Administration begins not later than 1 hour following the start of the preparation of the CSP.
5.  Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the SCP, and the exact 1-hour BUD and time.
6.  If administration has not begun with 1 hour following the start of preparing the CSP, the CSP shall be promptly, properly, and safely discarded.