USP Revisions for Compounding Nonsterile Medicines
On June 1, 2019, the United States Pharmacopeia (USP) released new and revised standards aimed at ensuring the quality of compounded medicines.
The updates pertain to the USP General Chapters on compounding nonsterile medicines (USP <795> Pharmaceutical Compounding—Nonsterile Preparations), and compounding sterile medicines (USP <797> Pharmaceutical Compounding—Sterile Preparations). These chapters, along with USP General Chapter <800> (Hazardous Drugs – Handling in Healthcare Settings) will become effective December 1, 2019.
In this article we will review the substantive changes to USP <795> Nonsterile Compounding. Future articles will address USP <795> Sterile Compounding and USP General Chapter <800>. In anticipation of these changes, The Compliance Team will address revisions to our existing quality standards with an anticipated release by the end of 2019 or early 2020.
Goal of the Updates
The overall goal of USP <795> is to minimize harm, including death to human and animal patients that could result from:
1. Excessive microbial contamination
2. Variability from the intended strength of correct ingredients (+/- 10%)
3. Physical and chemical incompatibilities
4. Chemical and physical contaminants
5. Use of ingredients of inappropriate quality
Nonsterile Compounding: Combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling or otherwise altering a drug or bulk drug substance to create a nonsterile medication.
Compounded Nonsterile Preparations: A preparation intended to be nonsterile created by combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering of a drug or bulk drug substance.
List of Updates/Changes
Note: All of these changes should be incorporated into the pharmacy’s standard operating procedures (SOPs)
1. Microbial contamination must be addressed
2. A Designated Person(s) must be named who is responsible and accountable for the performance and operation of the facility and personnel in the preparation of Compounded Nonsterile Preparations (CNSP)
3. Any mention of hazardous drugs is now contained in USP <800>
a. Storage area temperature MUST be monitored and recorded daily
b. Compounding Area MUST be specially designated for nonsterile compounding
c. If preparing any hazardous drug CNSPs that are listed in the National Institute for Occupational Safety and Health (NIOSH) compendia, then the facility design MUST be in an appropriate negative pressure segregated compounding room. (This will be discussed further in a future USP <800> review article.)
5. Cleaning and Sanitizing: All surfaces MUST be cleaned and sanitized
a. Cleaning: The process of removing soil from objects and surfaces is accomplished by manually or mechanically using water with detergents or enzymatic products.
b. Sanitizing: The process of reducing, on inanimate surfaces, the number of all forms of microbial life, including fungi, viruses and bacteria.
i. Work Surfaces: At the beginning and end of each shift, between compounding CNSPs or when spills occur
ii. Floors: No carpeting, daily or after any spills
iii. Walls: Every 3 months or after any spills or surface contamination
iv. Ceilings: When visibly soiled or surface contamination has occurred
v. Storage Shelving: Every 3 months
a. Weighing, measuring or manipulating components that could generate airborne chemical particles MUST be done in a closed system environment.
i. Containment Ventilated Enclosure (CVE)
ii. Biological Safety Cabinet (BSC)
iii. Must be certified every 12 months
a. Active Pharmaceutical Ingredients (API) MUST:
i. Comply with USP-NF monograph
ii. Present a Certificate of Analysis (COA)
iii. Be obtained from an FDA registered facility
8. Beyond Use Dates (BUD) are the date, or the hour and date, beyond which the CNSP cannot be used and MUST be discarded
a. Factors to Consider:
i. Chemical and physical properties of the API
ii. Compatibility of the container-closure system
iii. Degradation of the container-closure system
iv. Potential for MICROBIAL CONTAMINATION (NEW)
b. Extending BUDs:
i. MUST not exceed the BUD specified in USP-NF monograph
ii. Aqueous and nonaqueous CNSPs may be extended to a maximum of 180 days but MUST have a stability study using a stability-indicating assay for the API, CNSP and type of container-closure that will be used
What practices are not subject to USP <795>?
Administration: Preparation of a single dose for a single patient when administration begins with 4 hours of the beginning of the preparation.
Nonsterile Radiopharmaceuticals: This is subject to USP <825> (Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging)
Reconstitution of a conventionally manufactured nonsterile product: Only if in accordance with the directions contained in the manufacturer approved labeling.
Splitting Tablets: Breaking or cutting a tablet into smaller portions.
Repackaging: repackaging of conventionally manufactured drug products.
If you have questions about the changes and updates, please contact The Compliance Team at 215-654-9110.
Yes you can deliver diabetic supplies!
Competitive bid contracts expired on December 31, 2018. This included the contracts for national mail order diabetic supplies. The current round of bidding, with contracts to take effect on January 1, 2021, does not include diabetic supplies.
What does this mean to your pharmacy or durable medical equipment company? The restriction on delivery of diabetic supplies the National Supplier Clearinghouse is no longer in place, and your business is now able to offer the convenience of delivery of diabetic supplies to your patients.
If you are delivering in person, and already accredited for glucose meters and supplies (non-mail order product category DM05), no action is needed. If you are delivering through the mail, you must also be accredited for mail order glucose meters and supplies (product category DM06).
If your business is not currently accredited for mail order, and you are interested in mail delivery, please contact our home office at 215-654-9110 or submit your request/question via the “Client Services” tab on our website.
Announcing expanded after-hours coverage.
The Compliance Team is pleased to announce that we now have live coverage of after-hours calls for our clients! Our home office is in the Philadelphia area and closes at five o’clock PM Eastern Time.
Now our West Coast based Call Advisors are responding to calls made to the home office until 5 PM Pacific Time (8 PM Eastern). Give us a call and we’ll be happy to assist you – 215-654-9110.
Don’t forget that questions on a variety of topics can be submitted via the “Submit a Question” option under the “Client Services” tab on our website (www.thecomplianceteam.org). Our Call Advisors respond to accreditation and quality standards related questions, while our home office staff will help you with questions regarding billing, scheduling, certificates, etc. Please tell us who you are, how and when to reach you, and the specifics of your question. We will get back to you within 24 business hours.
“We have found The Compliance Team to be an invaluable service. Their professionalism and expertise ensure we are not only compliant with Centers for Medicare & Medicaid, we also have an expert when needed to provide support and guidance, no matter how large or small our query is. We have been very pleased with the services they have offered. I would highly recommend them to anyone looking for Accreditation in Healthcare.” – Joann Leible, Pharmacy Manager, Calix Drugs Pharmacy Inc., Covina, CA
Exemplary Provider Decals
We have new Exemplary Provider digital decals that you can add to your website or to your marketing materials. You can choose between generic or custom decals that include the accreditation tracks e.g. DMEPOS, Community Rx + DMEPOS, Long Term Care Pharmacy, Specialty Drug. Contact Marilyn, our communications advisor, for details, firstname.lastname@example.org.
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Office: (215) 654-9110
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