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Updates to Our Liquid Sinus Rinse Formulations (Impacting Nasal Nebulizer, Mygind’s and Atomizer Uses)
Providers and patients are constantly proclaiming their preference for our liquid sinus rinse formulations for their benefits, including ease of use, broader insurance coverage and flexibility in delivery. While some regulations are changing, we’re committed to continuing to provide these superior sinus rinse products for your patients. As a pharmacy that has been in the compounding business for over 30 years, innovation is in our DNA and it’s one of our Core Values.
Beginning on November 1, 2023, state boards of pharmacies adopted new revisions to the United States Pharmacopeia standards for compounding of non-sterile, sterile, and hazardous drugs. Among the changes are limitations on beyond-use-dating for medications with certain water activity levels. As a result, MCSP has transitioned its concentrated corticosteroid sinus rinse medications from a saline base to an ethanol base. This change is beneficial for several reasons:
These new formulations will appear clear as the medication goes into solution without rigorous shaking. This makes the medications easier to use and travel-friendly. It also creates a more consistent homogenous dispersion of the active pharmaceutical ingredient throughout the drug dosage form. In addition, significant 240:1 dilution of ethanol in a saline rinse bottle makes ethanol undetectable, highly effective, and comfortable to use for patients. We have always made Mupirocin rinses in an ethanol base without issue, so we are confident the medication is comfortable for patients when used in a sinus rinse bottle and diluted with 8 oz of saline; however, these liquid concentrates do require some dilution prior to application.
For prescribers who use or plan to use these medications in low-volume rinses (i.e. with a nasal nebulizer, atomizer, or in Mygind’s position), please be sure to indicate that in the prescription, and our team will provide dilution instructions for the appropriate methodology or reach out to your office with further options. Additionally, if prescribers have questions, please consult our pharmacists directly by dialing (910) 763-1896 (Option 1, Option 1).
FAQ on Our New Sinus Rinse Liquid Formulations
What medications will be impacted by MCSP’s new formula update?
Our steroid liquid concentrates, or those in our small glass dropper bottles, are the only formulations to change at this time.
Will these changes impact the way patients prepare their medications?
These changes do not impact how patients who use a large volume sinus rinse prepare their medications for use. We do, however, recommend those patients who use a small volume rinse (either via nasonebulizer, atomizer, or in mygind’s position) speak with one of our Customer Service Representatives about the best formulation for them. **These concentrates should not be used without previous dilution with saline.
Will these changes impact BUDs for patients?
Because of the industry-wide regulation changes impacting compounded formulations, this formulation change will allow us to extend the BUD (beyond-use date) from 35 days to 180 days, allowing patients to receive several months of supply at a time.
Are there any reported patient adverse reactions to the new formulation?
While this is a recent change to most of our concentrate formulations, our mupirocin concentrate has been in an ethanol base for many years with no reports of adverse reactions when diluted as directed. We will work alongside providers to ensure patients are counseled how to correctly administer their medications based on the formulation provided. **It is of utmost importance that the patient’s prescription represents the delivery method they are using as advised by the provider.
Why is MCSP making these formula changes now?
As of November 1, 2023, the new revisions to USP 795 & 797 will take effect. These are the standards by which all non-sterile and sterile compounding must occur. We are held to these compounding standards by our regulating bodies: the Boards of Pharmacy and Pharmacy Compounding Accreditation Board (PCAB).
Does the temperature affect the new compounded formulation?
These formulations will not require refrigeration to reach their beyond-use date specified on the label. They should be stored at room temperature.
Will the label still state “Shake well before use”?
Because these medications are soluble in the ethanol base, they will form a solution and therefore, will not require the patient to shake to mix prior to administration. This removes the variability of how well a patient re-suspends their medication which should ensure increased efficacy.
What is the benefit of the formula change to patients?
We believe our liquid formulations are easier to use and provide greater flexibility across delivery methods while ensuring optimal drug application. Patients will continue to have access to multiple months’ supply at a time, reducing their cost burden and increasing compliance
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