by | September 24th, 2019

On Sept. 23, the Healthcare Quality and Safety team at USP issued a letter announcing that it would delay the planned Dec. 1 implementation of three of its chapters: the revised <795> Pharmaceutical Compounding—Nonsterile Preparations and <797> Pharmaceutical Compounding—Sterile Preparations, as well as the new chapter <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging. After publication of the new and revised <795>, <797> and <825> compounding standards, USP received appeals about certain provisions they wanted to implement. “In accordance with USP’s Bylaws, the responsible Expert Committees worked with a sense of urgency to consider the information raised in the appeals and issued decisions on the appeals,” the Healthcare Quality and Safety team wrote in a letter to stakeholders.  “In accordance with USP’s formal appeals process, stakeholders who submitted appeals on the compounding chapters have requested further review by an appointed Panel. USP’s Bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending.” USP <800> is not subject to any pending appeals, and will still become official Dec. 1.  USP noted in its letter that while the other chapters remain postponed, <800> is “informational and not compendially applicable.” What does that mean? “It means that it’s an official chapter, but since it’s compendially related to <795> and <797>, isn’t enforceable until the others are official,” explained Patricia Kienle, RPh, the director of Accreditation and Medication Safety for Cardinal Health. “USP, of course, does not enforce these chapters; state boards of pharmacy and other regulators and accreditation organizations do. Some states have said that they are going to enforce <800> beginning on Dec. 1, but we don’t know yet how this will affect those plans.” To resolve the status of the other three chapters, USP’s bylaws call for the appointment of an independent panel to determine whether all of the appeals have been sufficiently addressed. According to the USP bylaws, the panel should be chaired by the president, who will appoint three members of the Council of Experts and up to three additional experts; and the chair of the board will appoint three members of the board of trustees. It’s unclear how long the independent panel’s review will take. “It’s not going to be overnight. The panel will first have to be appointed, and then they will have to review all of the issues that people raised,” Ms. Kienle said. “I advise people to stay the course. This is just a little bump in the road as far as timing. I would think of it as giving you a little extra time to ensure that you are compliant, but don’t stop doing what you’re doing.” About USP USP is an independent scientific organization that develops quality standards for medicines, dietary supplements, and food ingredients in an effort to increase the availability of quality medicines, supplements and food for people around the world.  References

1.  United States Pharmacopeial Convention. Compendial Notices: USP General Chapters <795>, <797>, <800>, and <825>. USP website. 09/23/19/.  Accessed 09/24/19

2. Pharmacy Practice News   Accessed 09/24/19