FAQs

To view the answers to the questions below, click on&nbsp; the section to expand the list. If your question isn&rsquo;t&nbsp; answered on this page, please <a href="../../../../contact-us">contact us.</a>

Should a recall be necessary, a representative will contact you via email. We will also follow up with you by phone to confirm receipt and purchase status.

How do you handle recalls? Can you track my product and lot purchases and notify me if we purchased that product and lot?

We do not produce any drugs manually. Our aseptic manufacturing process uses automation in the compounding, sterilizing, filling and sealing of finished product &mdash; no hoods.

Why didn’t I see any hoods in the compounding area when I visited your facility?

A CoA is included with every order for every lot. If you need an additional copy, request one for the lot in question by going to <a href="../../../../contact-us">Contact Us</a> and choose the CoA/QA category from the drop-down menu. You will find the lot number on the product label.

How can I obtain a Certificate of Analysis (CoA)?

Contact Customer Service or your SAGENT&reg; sales representative and request a status update.

How/where can I check my order status?

Yes. For details, please visit the <a href="https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities" target="_blank" rel="noopener">FDA Registered Outsourcing Facilities website.</a>

Has your facility undergone an FDA inspection?

QA reports are available electronically within the online ordering portal by clicking on &ldquo;Quarterly Reports&rdquo; in the top bar, or you may contact Customer Service to request a copy.

Where can I find your quarterly QA report?

Is your bar code on the overwrap the same as the code on the product?

Yes. See the Benefits of SterRx Premixed IV Solutions on our <a href="../../../../resources">Resources </a>page.

Are your containers DEHP-, PVC- and latex-free?

If the contact person on the order placed did not receive a carrier alert, you can contact Customer Service or your SAGENT sales representative for assistance.

How can I track my shipment?

We source our bulk API from FDA-registered suppliers and its orders are accompanied by a Certificate of Analysis (CoA) from the supplier. Section 510 of the Federal Food, Drug, &amp; Cosmetic Act (FDCA) and FDA regulations require all API suppliers to register with FDA. FDCA Section 503B(a)(ii)(C) and (D) requires outsourcing facilities to obtain bulk API from suppliers registered under FDCA Section 510, and states API must be accompanied by a valid CoA. Notwithstanding, SterRx&rsquo;s compounded formulations are not approved by FDA, and have not been reviewed by FDA for safety or efficacy.

Where does SterRx source its bulk Active Pharmaceutical Ingredients (API) in its compounded formulations?

We set high standards for quality and sterility for each compounded product that&rsquo;s produced.&nbsp;
&nbsp;
SterRx is an FDA-registered 503B outsourcing facility that manufactures high-quality cGMP-compliant products with minimal human intervention. Our aseptic manufacturing process uses automation in the compounding, sterilizing, filling and sealing of finished product &mdash; no hoods. Blow-fill-seal (BFS) and other automated technologies are used to produce sterile products, which helps reduce the chance of contamination.&nbsp;
&nbsp;
While other compounders may use beyond-use dating, our products are assigned an expiration date using real-time stability testing, which is a more precise statement of product viability. We follow the regulatory requirements and guidance for 503B compounding, utilizing Current Good Manufacturing Practices (cGMP), and produce sterile compounds from non-sterile ingredients. We source API from FDA-registered suppliers to formulate and produce our sterile products.

How is SterRx different from other 503B facilities?

We are registered in all 50 states and the District of Columbia.

In what states are you registered?

Our BFS containers are made from pharmaceutical-grade LDPE (low-density polyethylene) resin.

What material do you use to make your Blow-Fill-Seal (BFS) IV bag containers?

We do not apply any specific constraints regarding weather-related temperature variations. However, depending on the nature of a specific order, we make every effort to mitigate shipping during extreme cold weather to help minimize risks during transit.

What are your extreme weather shipping policies?

Our current product offerings are located on the <a href="../../../../products">Products</a> page. You can also place orders for SterRx products through our convenient customer<a href="https://order.sterrx.com/signin.aspx" target="_blank" rel="noopener"> ordering portal</a>.

What drugs do you compound and how can I order?

No. Our products are assigned an expiration date using real-time stability testing, which is a more precise statement of product viability than a beyond-use date.

Do you use beyond-use dating on your products?

We have a rigorous QA program:
<ul>
<li>All incoming materials are quarantined until examined and released by QA.</li>
<li>SterRx qualifies all equipment and validates all processes and products.</li>
<li>The entire facility is environmentally monitored, along with clean rooms and equipment.</li>
<li>All drugs are placed on stability to establish science-based expiry dating.</li>
<li>All products are released only after testing to cGMP standards.</li>
<li>All products are tested for sterility, endotoxin, pH, appearance, and potency prior to release.</li>
<li>SterRx has a dual independent QA system: the standard cGMP system used by drug manufacturers, and a 503B pharmacy-based system. No drug can be released until both systems have signed off.&nbsp;</li>
</ul>

What procedures does SterRx have in place for Quality Assurance (QA)?

Yes. The procedure for hanging and spiking SterRx BFS IV bags is located on our <a href="../../../../resources">Resources </a>page.&nbsp;

Are there instructions for spiking BFS IV bags?

Under Section 503B of the FDCA, SterRx&rsquo;s drugs are exempt from FDA approval and adequate directions for use requirements, so long as SterRx operates in compliance with Section 503B&rsquo;s requirements. Thus, SterRx&rsquo;s compounded formulations are not FDA-approved and have not been reviewed by FDA for safety or efficacy.

Are SterRx products FDA approved?

All traditional or commercial dispensing spikes are compatible.

Which spikes are compatible with your port?

The ports are universally compatible with all common IV administration set spikes.