adhere to a separate set of USP stan- dards specifically for allergen extract mixing, they can compound allergen extracts in an office setting using aseptic technique. They don’t have to worry about the more stringent standards that apply to higher-risk compounding preparations, including stricter environmental controls and shorter beyond-use dates (BUDs) for the compounds. According to a com- ment letter AAAAI, ACAAI, and other organizations submitted to USP, that arrangement has worked well. To read the AAAAI letter, visit tma.tips/ AAAAIComments. The letter says the preparation of
“I can safely tell you to keep it in the hands of the doctor, and I think everything will be fine.”
allergen extracts using aseptic tech- nique has a sterling safety record go- ing back more than 100 years. “We estimate that over 16 million subcutaneous allergy immunother- apy injections are given annually in the United States to over 2.6 million people,” the letter said. “Yet out of the many millions of injections adminis- tered to millions of patients over sev- eral decades, there are no reported in- fections. This is clear evidence of the safety of current practice.” But USP’s proposed revisions
would change things dramatically for immunologists. While the current standards split compounded sterile preparations (CSPs) into three risk levels — low, medium, and high — the revised standards would carry just two CSP risk categories: Category 1 and the higher-risk Category 2. “No sterile compounding is inher-
ently ‘low risk,’ and preparation of all CSPs must be done carefully,” USP said in its briefing on the proposed standards. The new Category 1 CSPs involve
procedures with a BUD of 12 hours or less at controlled room tempera- ture or 24 hours or less if refrigerated. Category 2 CSPs are those with higher
+ 64 TEXAS MEDICINE May 2016
BUDs; that category applies to the al- lergen extract compounds patients take over weeks, months, and years of treatment. USP’s revisions remove the exemp-
tion for allergen extract preparations, eliminate the separate mixing proce- dures for those preparations, and in- troduce some new standards. The letter to USP from the allergist
organizations notes the new standards would require allergists to perform:
• Office renovation to meet more stringent engineering controls;
• Environmental sampling for viable and nonviable airborne particles;
• Ongoing sterility testing in ac- cordance with USP specifications, which the letter says will delay distribution of the compounds to patients; and
• Discarding of all compound prepa- rations after they reach a BUD of either 28 days or 42 days, depend- ing on whether the compound is at room temperature or refrigerated.
The proposed language requires a
clean room environment for Category 2 extract preparation. Clean rooms are environments with low, controlled levels of contamination. “Now, they essentially want our
current work spaces to be turned into labs that are especially designed for controlling risk of infection or con- tamination at the highest levels,” Dr. Ramirez said. Shawn Becker, a nurse and USP’s
senior director of health care quality standards, says USP’s Compounding Expert Committee has been revising the standards since 2010. The commit- tee formed an expert panel in 2013 to look at the standards. The chair of the 18-person expert committee, veteri- nary pharmacist Gigi Davidson, also chaired the expert panel.
USP proposed revisions to compounding standards: tma.tips/USPCompounding
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