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Sterile Ophthalmic Compounding: What Prescribers Should Know

The primary goal of healthcare providers is to ensure patient safety while providing the greatest health benefits to patients. Often, commercial medications fail to accomplish this goal for individuals due to a variety of reasons, including limited dosage forms, the presence of allergens, or other limiting options. In these and other situations, a patient-specific medication may be created by a compounding pharmacy to meet the needs of individual patients as long as all other criteria are met according to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

Compounding spans many therapeutic areas, and different medications need alternate administration routes, some of which require additional expertise and training as well as appropriate and compliant facilities. Ophthalmic compounding is a niche area of compounding that requires highly specialized knowledge to prepare safe and effective sterile compounded medications to treat conditions such as diabetic dry eye disease, corneal scarring, bacterial infections, and more. 

Although there have been high-profile safety incidents in the past, Congress quickly acted to strengthen regulations around compounding pharmacies by increasing FDA oversight of compounding pharmacies in 2013. When created by a licensed 503A compounding facility, ophthalmic compounded preparations are safe and effective, and prescribers can check to ensure their ophthalmic products are being prepared in a facility compliant with all relevant regulations.

How To Ensure Sterile Ophthalmic Compounding is Safe

Prescribers must be confident that the ophthalmic drug they’re about to prescribe and/or administer was compounded in a sterile environment to prevent microbial contamination and other dangerous impurities. Thus, prescribers will rightfully have questions about who is preparing sterile ophthalmic compounded preparations and the nature of the lab.

Check Accreditation and Licensure

First, check that the pharmacy and pharmacists are appropriately licensed. Beyond that, determine accreditation status, as this indicates that the pharmacy is open to additional external scrutiny above and beyond FDA regulations and USP guidelines.  Transparent and compliant facilities intentionally subject themselves to third party inspections.

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503A compounding pharmacies are regulated by state boards of pharmacy and must strictly adhere to FDA regulations and USP guidelines. As a compounding pharmacy, we are continually monitoring for updates to these regulations and guidelines and act quickly to implement any changes to remain in compliance. In some cases, this may mean that we refuse to compound certain medications to avoid violating the regulations we are governed by.

Check for Form 408 or Warning Letters

FDA inspects compounding facilities and may issue a Form 483 if they observe regulation violations. FDA Form 483 is issued when FDA conducts an on-site inspection of a facility and finds “…any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.” If the violation is serious enough, a Warning Letter may be issued. 

Prescribers may search for Form 483 and Warning Letters on the FDA website. At VLS Pharmacy & New Drug Loft, we have a clean history with this process, underscoring our commitment to patient safety.

Ensure that Quality Assurance Protocols Are In Place

We ensure quality control similar to a large pharmaceutical manufacturing facility by continually monitoring our lab’s temperature, humidity, and airflow 24/7/365 by: 

  • Being compliant with both USP <71> and USP < 81> for in-house sterility and anti-microbial assay testing.
  • Using HEPA-filtered airflow ISO Class 5 laminar flow hoods to prevent sample contamination and create a particulate-free work area. 
  • We also ensure sterility by using an autoclave and using single-wear full garbing with head-to-toe coverage.

In addition to sterility and endotoxicity, potency must also be assessed, as some ophthalmic medications have narrow therapeutic indices, which may lead to dosing errors if compounded inaccurately. To ensure accurate dosing in the final preparation, we use high-precision balances with an anti-static draft shield when weighing APIs and other components of our compounded preparations.

To confirm potency (as well as sterility and endotoxicity), all of our compounded ophthalmic preparations undergo a Quality Assurance (QA) protocol, verification by a licensed pharmacist. After preparation, we assign an appropriate beyond-use date (BUD), as determined by USP chapter <797>.

quality control process chart | newdrugloft.com

Ensure API Safety 

Even if sterile compounding is performed according to all regulations and guidelines, if the API is not sourced from an approved FDA supplier, there is no guarantee of the final preparation’s safety or effectiveness. This is one reason why we source all of our USP-grade APIs directly from the leader of superior-quality APIs, PCCA, who test each lot against their certificates of analysis (C of A) according to USP, EP, NF, FCC, ACS, and PCCA standards. 

Ask the Compounding Pharmacy Questions 

In addition to the above items, the compounding pharmacy you choose to partner with should be willing and able to answer any other questions or concerns you may have about their processes. We are always happy to answer any questions you may have about our sterile ophthalmic compounding process. Simply send us an email at info@vlspharmacy.com or call us.

In Addition to Being Safe, Our Fulfillment Process is Easy

Here’s how our prescription fulfillment process at VLS Pharmacy & New Drug Loft works as part of our more lengthy quality control process:

  1. Providers submit their scripts through their EMR system or via FAX to VLS Pharmacy at 855-491-0799.
  2. We process scripts within 24 (business) hours of receipt.
  3. Then, the patient will receive an automated phone call or text, where they have the option of speaking with a live person. We also send a text message with their order number and a link for the patient to pay online. 
  4. Once payment is made, we begin compounding the patient-specific medication and then package your order and ship it via FedEx overnight.

Note: First-time prescribers must fill out a New Prescriber Account Form.

Why Choose VLS Pharmacy & New Drug Loft?

When performed correctly and safely by a licensed 503A pharmacy, ophthalmic compounding provides individual patients with medications that are tailored to meet their specific needs. To ensure the sterility of our ophthalmic preparations, we have designated cleanrooms and USP <797> sterile rooms, and our sterile compounding staff are trained by the Professional Compounding Centers of America (PCCA) to work in sterile compounding.

 

We understand that you may have questions about our ophthalmic compounding process or facilities, and we’d be happy to answer these questions! Please comment below or reach out to our team to learn about best practices and to partner with our experts on custom ophthalmic compounded medications for your patients. As noted above, all medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.

 

 


 

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