Terms and Conditions

WBRx Terms and Conditions
Privacy Policy
WBRx Biologics, LLC (“WBRx” or “the Company”) is committed to customer service and we intend to uphold
this by providing a private and secure browsing experience. The following policy will help you to understand
how we will treat your personal information. As we continue to improve our site and as we take advantage of
developments in technology, this policy may change from time to time so please check this policy on an
ongoing basis for revisions and updates.

Information Collection and Use

WBRx collects information from our web site in several ways. During registration, WBRx asks for information
such as your name, phone number, and email address. Once you have submitted this information and chosen a
valid password, you will be able to take full advantage of everything WBRx has to offer. You may also be asked
for personal information when you report a problem with our site, or services; or, if you otherwise contact
WBRx. WBRx also collects information using cookies, which are small pieces of information that are stored by
your browser on your computer’s hard drive. This information allows us to automatically link our customers to
their personalized accounts. Most web browsers automatically accept cookies. Please check your browser’s
guidelines should you wish to prevent cookies. WBRx is the sole owner of the information collected on this
site. We will not sell, share, rent or otherwise distribute this information to others in ways different from what
is disclosed in this statement. Information is collected with the sole purpose of providing WBRx products and
customer service.

Information Disclosure

When you are on the WBRx site and are asked for personal information, you are sharing that information with
only WBRx, its agents and representatives. WBRx will not disclose any of your personally identifiable
information except when we have your express permission or under special circumstances, such as when we
believe in good faith that the law requires it. WBRx may also disclose account information in special cases
when we have reason to believe that disclosing this information is necessary to identify, contact or bring legal
action against someone who may be causing injury to or interference with (either intentionally or
unintentionally) WBRx’s rights or property, other WBRx users, or anyone else that could be harmed by such
activities. WBRx will comply with the requests of all recognized legal entities to aid in the stopping of spam,
distribution of illicit sexual content to minors, or any other illegal activity brought to our attention through
such channels.
WBRx may occasionally send you emails or texts about products and services that we feel may be of interest to
you. Only WBRx (or agents or representatives working on behalf of WBRx) will send you these emails. You may
unsubscribe from the service information updates without any future correspondence or questions by filling
out the Opt-Out Form.

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Shipping Policy
WBRx products are only available in the United States. Orders process within 24-48 hours from the time you
place your order and the average transit time is 5-7 business days. Transit times will vary based on your
location. WBRx Global is not responsible for lost or stolen items. Once our carriers indicate that the item has
been delivered, we consider the order complete.
All shipments are sent through USPS, UPS, FedEx, and DHL. Carriers may also vary depending on your location.
If a product is damaged at the time of delivery, you must make a claim within 10 business days
by [email protected] .

Refund Policy
On all cash pay items shipped we have a 30-day refund policy. If you are dissatisfied with the WBRx products or
you have changed your mind – we will refund the order as it is within 30 days of placing your order. To be
eligible for a refund, all items must be returned in resalable condition. We do not issue partial refunds/returns.
Please refer to the contact page for our return addresses. You will be refunded for the product value only less
than 10% restocking fee. For questions, please email [email protected] or refer to our Return Policy for
further information.

FDA Disclaimer
These statements have not been evaluated by the FDA and are not intended to diagnose, treat, cure or prevent
any disease. In the US, use of cell therapy products is codified within the Code of Federal Regulations in the
following sections: IND regulations (21 CFR 312), biologics regulations (21 CFR 600) and cGMP (21 CFR 211).
In particular, US federal regulation on cellular therapy is divided into two sections of the Public Health Service
Act (PHSA), referred to as “361 products” and “351 products”. Traditional blood and bone marrow progenitor
cells as well as other tissues for transplantation fall into 361 products definition. The Food and Drug
Administration (FDA) has established that cells or tissues used for therapeutic purposes and the regulation that
pertains to processing of 361 products are codified under the Good Tissue Practice (GTP).[7] CFR, Part 1271
provides US regulations on Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).[12] This
became effective in 2005 as rules for HCT/Ps. The FDA has also issued guidance documents about how the
drug, biologic, and device regulations apply to cellular and genetic therapies.[13]Classification of stem cell
based therapies is based on indication to be treated. Restrictions are limited to research with federal funds. No
limitations exist for research with hESCs, provided the funds come from private investors or specific states.
The FDA has developed a regulatory framework that controls both cell- and tissue-based products, based on
three general areas:[8]

Prevention of use of contaminated tissues or cells (e.g. AIDS or hepatitis);
Prevention of inadequate handling or processing that may damage or contaminate those tissues or cells; and
Clinical safety of all tissues or cells that may be processed, used for functions other than normal functions,
combined with components other than tissues, or used for metabolic purposes.
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The Center for Biologics Evaluation and Research (CBER), the division of US FDA that regulates
stem cell based therapies, has so far approved ApliGraf®, Carticel® and Epicel®. Those
cell-based therapeutics “that are, minimally manipulated, labeled or advertised for homologous use
only, and not combined with a drug or device” do not require FDA approval.[14] In contrast,
manipulated autologous cells for structural use meet the definition of somatic cell therapy products
and require an “investigational new drug” (IND) exemption or the FDA license approval. In 2007,
the “Guidance for Industry: Regulation of HCT/Ps – Small Entity Compliance Guide” and in 2009,
the “Guidance for Industry on Current Good Tissue Practice (cGTP) and Additional Requirements
for Manufacturers of HCT/Ps” (http://www.fda.gov) had been released.[15] Clinical studies
employing mescenchymal stem cells (MSCs) underlie the IND mechanism. Accordingly, the
investigators have to make an IND application, which necessitates detailed study protocols
describing the clinical plan as well as the preparation and testing of the therapeutic cell

Under the current FDA policies, there are at least two ways in which physicians may administer
more than minimally manipulated stem cell products to patients. The first is under the FDA’s
program for expanded access to investigational drugs and biological products for treatment use
(what is sometimes referred to as “compassionate use”) as long as these products are currently
being tested elsewhere in a CT and only if expanded access will not interfere with the conduct of
clinical investigations. FDA allows clinicians to charge for direct cost recovery and administrative
costs associated with expanded access use.[17] The second is the off-label prescribing of
FDA-approved stem cell products. Off-label prescribing is premised on the position that the FDA
does not have the authority to regulate medical practice and the assumption that physicians can
be trusted to use their professional judgment in deciding how to treat their patients.[18]
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Legal Disclaimer
Information on this site is provided for informational purposes only and is not meant to substitute for the
advice provided by your own physician or other medical professional. The results reported may not necessarily
occur in all individuals. WBRx/WBRx Global are providing this site and its contents on an “as is” basis and make
no representations or warranties of any kind with respect to this site or its contents. Except as specifically
stated on this site, neither WBRx/WBRx Global, nor any of its directors, employees or other representatives will
be liable for damages arising out of or in connection with the use of this site. This is a comprehensive limitation
of liability that applies to all damages of any kind, including (without limitation) compensatory, direct, indirect
or consequential damages, loss of data, income or profit, loss of or damage to property and claims of third

Contact Us
[email protected]
9789 Katy Freeway, #1801
Houston, TX 77024
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