Beginning with the current Sep/Oct 2017 issue of the International Journal of Pharmaceutical Compounding, we will be sending out an "eTOC" (electronic Table of Contents) to all CompoundingToday.com Newsletter recipients for your perusal. We hope this service will be of value to you.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Announcement from USP

In accordance with section 7.07 of the Rules and Procedures of the 2015-2020 Council of Experts, this is to provide notice that USP is announcing the intent to postpone the official date of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings.

The intent of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, to provide a unified approach to quality compounding. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September-October 2018 for a second round of public comment and is expected to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard.

USP encourages early adoption and implementation of General Chapter <800> to help ensure a safe environment and protection of healthcare practitioners and others when handling hazardous drugs. We will continue to support our stakeholders through education and outreach.

Should you have any questions, please contact Jeanne Sun, Manager, Compounding, Healthcare Quality & Safety (CompoundingSL@usp.org).

News and Did You Know...

A recent headline reads:

"A Case of Hemorrhagic Occlusive Retinal Vasculitis (HORV) Following Intraocular Injections of a Compounded Triamcinolone, Moxifloxicin, and Vancomycin Formulation"

One gets the immediate impression that the fault lies with the "compounding pharmacy." The pharmacy is a 503b Outsourcing Facility. Let's look at it in more detail.

• FDA received an adverse event report on August 14, 2017 from a physician concerning a patient who was diagnosed postoperatively with bilateral HORV after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgery procedures that were done two weeks apart.
• The TMV formulation was compounded by Imprimis Pharmaceuticals, Inc., located in Ledgewood, New Jersey.
• Many ophthalmologists use intraocular vancomycin during cataract surgery with the intent of preventing postoperative endophthalmitis.
• FDA is unaware of any adequately controlled studies demonstrating the safety and efficacy of intraocular vancomycin in preventing endophthalmitis.
• There is no FDA-approved vancomycin formulation for intraocular injection. The formulation is usually prepared at the surgical site or obtained in advance of surgery from a compounding pharmacy.
• The use of intraocular vancomycin has recently been associated with the newly described condition HORV.
• No cases of HORV were reported in a retrospective analysis of medical records of 922 patients (1541 eyes) who underwent cataract surgeries with intravitreal injections of compounded TMV formulations from November 2013 to December 2015.
• The adverse event being reported here serves as a reminder that intraocular administration of vancomycin, including when the vancomycin is one of multiple active ingredients in a compounded drug, can result in HORV.
• FDA approved on September 28, 2017, a supplemental new drug application that adds a subsection about HORV to the WARNINGS section in the labeling of Vancomycin Injection, USP. The warning states:

  Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials. Vancomycin is not indicated for prophylaxis of endophthalmitis.

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation
/PharmacyCompounding/ucm578514.htm

One question that is unanswered is, "Why were the physicians not listed in the article the same as the compounding pharmacy as they initiated its use, not the pharmacy?" It appears the pharmacy did nothing wrong but are being mentioned for shock value and for all to scrutinize!

Tip of the Week

The lesson to learn here is that not everything you read is true as presented. (Surprised?) Partial disclosure, even in a headline, can be misleading and should not be tolerated.

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Looking Back

Men with whiskers,
'Neath their noses,
Oughta have to kiss,
Like eskimoses!
     Burma Shave