Section one
Acceptance of These Terms
These Terms of Service set out the conditions under which the website of GFC Pharma LLC may be used and under which the compounding and formulation services that it describes may be requested. By opening any page of this website, you agree to be bound by these terms. If you do not agree with any part of these terms, you should not continue to use the website and you should not place an order.
These terms apply to every visitor of the site, and they apply with equal force to a person who only reads the pages and to a licensed prescriber or an institution that submits a compounding order. Because compounding touches the safety of patients, the standards in these terms are intended to protect everyone involved: the patient who receives the preparation, the prescriber who is responsible for the order, and the laboratory that prepares and releases the product.
A separate document, the Privacy Policy that is available on this website, explains how information about visitors is collected and handled. The Privacy Policy forms part of your agreement with us, and it should be read together with these terms. Where a specific service is the subject of a separate written agreement that you sign, that separate agreement will govern the points it covers, and these general terms will apply to everything else.
Section two
Who We Are
The services that appear on this website are developed and operated by the developer GFC Pharma on behalf of the company that is identified here. The responsible organization is GFC Pharma LLC, a company with its place of business at 1221 Independence Way, Westminster - 21157-3058, United States (US).
When these terms refer to we, us, or the company, the reference is to GFC Pharma LLC. The laboratory activity, including the compounding, the quality testing, the release decision, and the associated record keeping, is carried out by or under the direction of that company from its location in the United States. The personal details of the operator concerned with privacy and service matters are repeated in the section at the end of these terms.
Nothing in these terms creates a partnership, an employment, or an agency relationship between you and the company. Each party acts as an independent party responsible for its own conduct and its own obligations under the law.
Section three
The Nature of This Website
This website is an informational and business contact platform. It tells a reader about the compounding and formulation services that GFC Pharma LLC offers, it describes the laboratory discipline that governs the work, and it provides a way for a qualified professional to begin a conversation with the laboratory about a specific need. The pages of this website are not a substitute for a consultation with a physician, and they are not intended to give medical advice to any individual member of the public.
The content explains the operational framework of compounding in a general way, but it cannot describe every formula, every allowance, or every regulatory rule. The accurate application of those rules to a concrete order depends on the details of the order itself and on the law that is in force at the time. For that reason nothing on these pages should be read as a guarantee that a particular product can be made for you or that a described process applies without exception to your situation.
By using this website you agree that you will treat the material on it as general background information and that you will rely on the confirmations that the laboratory gives you directly for any decision about a real order, rather than on the general descriptions that appear here.
Section four
Eligibility to Use the Services
The compounding services of GFC Pharma LLC are intended for licensed health care professionals and institutions that are authorized to obtain and administer compounded preparations. To submit an order you must be acting within the authority that the profession gives you, and the preparation you request must be one that you are lawfully able to prescribe, dispense, or administer.
If you act on behalf of a clinic, a hospital, or a veterinary practice, you confirm that you hold the authority of that organization to place the order and to accept these terms on its behalf. If you are an individual member of the public, you may browse the website, but you should understand that compounding orders are accepted only through the lawful professional channel described above, and that the website does not offer retail products to consumers.
You also agree that you will use this site only for lawful purposes and that you will not attempt to interfere with its operation, to gain unauthorized access to its systems, or to overload the computers that serve its pages.
Section five
Compounding Orders and Requests
An order for a compounded preparation begins with a written request that reaches the laboratory through the channels described on the contact page. When your request arrives, we review it to confirm that it is legible, that the formula is complete, and that the preparation is one we can lawfully and safely make. This review does not by itself create a binding agreement; it is a stage of assessment before we accept.
Our acceptance is confirmed when we send you a clear statement that the order has been accepted, together with the details of what will be prepared. Until that confirmation is given, no order is binding on us and we may decline at our discretion under the rules described later in these terms. Once the order is accepted, we agree to prepare the product according to the confirmed formula, to test it to the standard that the release process requires, and to deliver it with the documentation that the care of the patient demands.
You agree that the terms we confirm at acceptance, including the dosage form, the strength, the container, and the beyond use date, define the scope of the particular order. Any change that you request after acceptance will be treated as a new request unless we agree that it is immaterial to the batch.
Section six
Required Documentation
A lawful compounding order rests on written evidence. Before we begin a batch you must provide the documentation that the applicable rules require, which normally includes a valid prescription or a written formula order from the prescriber, the clear identification of the patient or the intended use, and confirmation of the identity of the professional who is placing the request. We may also ask for the expected duration of treatment or the requested quantity where that information is needed to judge the order.
We hold the authority to ask for more written detail when the formula is unusual or when we need to satisfy ourselves that the order genuinely reflects the prescriber intent. You agree to produce the requests promptly and accurately, and you accept that a delay in providing documentation may delay the release of your product. We are not liable for a delay that is caused by the late arrival of material that we reasonably needed from you.
All documents that support a compounding order are retained as part of the batch record. Their retention is governed by the professional standards that apply to compounding and by the Privacy Policy of this website.
Section seven
Our Right to Accept or Decline
GFC Pharma LLC reserves the right to decline any order, in whole or in part, without assigning a reason. The company will not prepare a product that it believes to be unlawful, unsafe, or outside the proper scope of compounding, and it will not be forced to make a preparation merely because a request has been submitted.
Typical reasons for declining an order include an incomplete formula, an incompatible combination of substances, a question about the identity of the ordering professional, a missing certificate for a raw material, a beyond use date that cannot be defended through testing, or a concern that the preparation would not be in the best interest of the patient who would receive it. We will usually tell you when we decline, and we will do our best to explain the practical reason so that you can search for a lawful alternative.
Nothing in this section obliges us to justify a business decision, but we will always act in a manner that puts the safety of patients first, and we will never accept an order that we could not stand behind at release.
Section eight
Beyond Use Dates and Strength
Every compounded preparation that we release carries a beyond use date, which is the date before which we are able to defend the quality and the strength of the product under defined storage. That date is based on the specific formula, the container, the storage condition, and the supporting stability information that our release process considers. A beyond use date is not an arbitrary shelf life; it is a professional judgment that protects the patient from a product whose potency or purity can no longer be assured.
You agree to store each product under the conditions described on its label, to respect the applied beyond use date, and to discard any preparation once that date has passed or once the container shows signs that it may have been compromised. A product that has been opened, warmed, or contaminated should be handled with the same care that you would give to any medicine, and it should not be used beyond the window that we assign.
Where potency testing is performed, the results support the dated strength on the label. We do not promise that a particular preparation will keep its strength beyond the stated beyond use date, because no laboratory can honestly make that promise for a product that has left its control.
Section nine
Pricing, Payment, and Estimates
We will confirm the price of an accepted order in the written acceptance that we send you. Because compounding is performed to a specific formula, the cost of the raw materials, the labor, the testing, and the packaging together determine the final figure, and that figure can vary from one order to the next even when the products look alike.
Any estimate that we give before acceptance is an estimate, not a fixed quote. It reflects our current view of the cost based on the information you have given us at the time. If an unexpected increase in the cost of a raw material or an unusual step that arises during preparation would materially change the price, we will tell you before we proceed so that you can decide how you wish to continue.
Payment terms are those that we state when we accept the order, and they must be met before the product is released where we have agreed such terms. You are responsible for the full cost of an accepted order, including reasonable retesting and repackaging that becomes necessary as a result of an error in the information that you provided to us.
Section ten
Delivery and Handling
Compounded preparations are delivered using packaging and carriers that are appropriate to the product and to the required handling. Orders that need refrigerated or otherwise controlled transport are packed accordingly, and we will confirm the handling in the documentation that accompanies delivery.
Title to the product and the risk of loss pass to you at the point of delivery to the mode of transport that you have selected, unless we have agreed in writing that we hold the risk for a longer period. You agree to receive the delivery, to check the shipment promptly for damage or for a departure from the order, and to report any problem to us without delay in the manner described in the returns section.
Shipping times are estimates rather than guarantees. We will make a reasonable effort to release quickly, but we are not liable for a delay that is caused by a carrier, by the weather, or by a factor outside our reasonable control, and a delay does not give you a right to reject the goods unless the delay makes the product unusable.
Section eleven
Returns and Quality Concerns
Compounded products that have left the laboratory under temperature control of the type we assign are generally not returnable for ordinary reasons such as a change of mind, because the integrity and the storage history of the product can no longer be guaranteed once it is back in our hands.
If you believe that a delivery is damaged, that the wrong product was sent, that a product does not match the confirmed formula, or that an item has been compromised in transport, you must contact us at alert@gfcpharma.mom within a reasonable time after receipt and give us the batch number and a description of the concern. We will investigate the matter, and where we agree that the fault is ours we will arrange a replacement or an appropriate credit.
You agree not to attempt to return a product without first contacting us, and to follow the instructions we give you for the safe return, because the return of a medicine must be managed with care for the safety of everyone who handles it.
Section twelve
Proper Conduct and Safe Use
You agree to use every product that we release according to the label, the accompanying information, and the direction of the responsible prescriber. You will keep each product away from children, store it under the stated conditions, and never administer, apply, or dispense a preparation beyond its assigned beyond use date.
You will not open, dilute, or combine a product in a way that is not described, and you will not transfer a product into an unlabeled container. Any unusual change in appearance, odor, or behavior of the product should be reported to us so that we can consider whether it reflects a quality matter that affects the batch.
This obligation is not meant to burden you but to protect the very point of compounding: a medicine that is appropriate, tested, and used as intended. Careful handling on your side completes the discipline that begins in our hood.
Section thirteen
Adverse Event Reporting
If a patient experiences an unexpected reaction or an event that you believe is connected to a preparation that we compounded, you should notify us promptly and you should follow any separate reporting duty that applies to your professional role. We ask for the batch number and the description of the product together with the nature of the event so that we can trace the lot and act on it.
We maintain a record of reports of this kind and we review each one for a sign of a systemic problem in a batch or in a process. Where an event raises a concern about the safety of a product that has already been released, we will take the steps that the circumstances warrant, up to and including advising that a batch be quarantined.
The report of an adverse event does not change the terms of our liability, but it is essential to the safe operation of compounding. That is why we ask for your cooperation and why we treat each report with the seriousness it deserves.
Section fourteen
Intellectual Property
All of the content on this website, including the text, the layout, the color scheme, the branding, and the written material that describes the services, belongs to GFC Pharma LLC or is used with permission. The content is protected by the rules of copyright and intellectual property that apply in the United States and elsewhere.
You may view the pages of this website for your own information and you may print or store a copy for that private purpose, but you may not republish, resell, reproduce, or distribute the content, in whole or in part, whether for a fee or for free, without our advance written consent. The name GFC Pharma and the word mark GFC Pharma LLC are used to identify the source of the services, and they may not be used in a way that suggests an affiliation that does not exist.
Nothing in these terms transfers to you any ownership of the content or of the goodwill that is attached to the marks. You agree to use the content only as these terms allow.
Section fifteen
Content Liability and Accuracy
We make a reasonable effort to keep the information on this website accurate and current, but the practice of compounding and the law that surrounds it change over time. We do not represent that every statement on the site will be complete, current, or free of occasional error, and the content is provided on an informative basis rather than as a binding professional promise.
Where a page contains general remarks about a substance or a process, those remarks are intended for a professional reader and should not be used as the sole basis for a clinical decision. The reliable confirmation for any specific order is the discussion that you have directly with the laboratory, not the summary text that appears on a general page.
You agree that you will not hold us responsible for a decision that you base on the general content of this website when the site offers a clear contact channel through which the accurate position for your own case could have been confirmed.
Section sixteen
Disclaimer of Warranties
To the fullest extent that the law allows, the website and its content are provided on an as is and as available basis, without any warranty of any kind, whether express or implied. This means that we disclaim the implied warranties of merchantability, fitness for a particular purpose, and non infringement, as well as any warranty that the site will be uninterrupted, secure, or free of faults.
The disclaimer above does not reduce the obligations that we carry toward the safety of the compounded products that we actually release. For each product that ships, we stand behind the batch record, the release testing, and the applied beyond use date, because those are the things that we control and that the patient relies upon.
Accordingly, this disclaimer of warranties speaks to the ordinary operation of the informational website, and it is not intended to, and it does not, excuse us from the professional duty we owe for each preparation that we certify and send out.
Section seventeen
Limitation of Liability
To the fullest extent that the law allows, GFC Pharma LLC will not be liable for any indirect, incidental, special, consequential, or punitive damages, or for any loss of profits, revenue, data, or goodwill, arising out of or in connection with the use of this website, however caused.
The limitation above reflects the practical reality that an informational website does not expose us to the kind of harm that a product liability claim would. Claims about the preparations themselves will be assessed against the professional rules that govern compounding, the batch documentation that we keep, and the report of any adverse event, and will be handled according to the law that applies to such matters.
Nothing in these terms excludes or limits a liability that cannot be excluded or limited under the law that applies to you, and nothing here removes a right that the law gives the person who receives our product. If a court finds a part of this limitation unenforceable, the rest of the limitation will continue to apply to the extent that it can.
Section eighteen
Your Agreement to Indemnify Us
You agree to indemnify and hold harmless GFC Pharma LLC and its staff from any claim, loss, damage, or expense, including reasonable legal costs, that arises out of a breach of these terms by you, out of a misuse of the website by you, or out of a false or incomplete statement in the documentation that you provided in support of an order.
This duty covers, for example, a claim that follows your use of a product beyond the assigned beyond use date, your dispensing of a product outside the authority that the law gives you, or your submission of an order that did not reflect the genuine intention of the prescriber.
The indemnity is limited to the extent that the law allows and it does not excuse us from our own share of responsibility where we have contributed to a harm through a fault of our own. Its purpose is to keep each party answerable for its own conduct rather than to shift a whole loss onto one side.
Section nineteen
Privacy and Your Information
Your use of this website is governed by the Privacy Policy that appears on the connected privacy page, and that policy is incorporated into these terms by this reference. The Privacy Policy explains what information we collect, how we use it, what rights you hold, and how you can contact us about it.
Where you supply information in support of a compounding order, that information is handled both under the Privacy Policy and under the professional record keeping rules that govern compounding, and where the two frameworks meet, the safer of the two protections will govern the data.
You confirm that the details you give us, whether through the contact form, the mailbox, or the order documentation, are accurate and that you are entitled to provide them. Where the information belongs to a third party, such as a patient, you confirm that you are lawfully in a position to share it with us for the handling of the order.
Section twenty
Governing Law and Disputes
These terms are governed by and interpreted under the laws that apply to the location of GFC Pharma LLC in the United States, without regard to the rules that would choose a different governing law. Any dispute that arises out of these terms or out of the services that they describe will be subject to the exclusive jurisdiction of the courts that have authority over the company, unless you are a protected consumer in a region whose law gives you a different forum.
Before a formal dispute is started, we encourage you to raise the matter directly with us so that we can seek a fair resolution. Many differences can be settled through a clear conversation about the batch record or the order documentation, and we prefer that course.
Where professional care is concerned, the standards of the profession and the reporting duties that apply to the compounding of medicines will continue to bind our conduct regardless of which forum hears a disagreement between us.
Section twenty one
Severability and Waiver
If a court holds that any provision of these terms is invalid or unenforceable, that provision will be read so as to give effect to its aim to the greatest extent that is lawful, and the remaining provisions will continue in full force. An invalid clause will not bring down the whole agreement.
If we fail to enforce a right under these terms at a particular time, that failure does not waive the right, and it does not prevent us from enforcing the same right at a later time. A waiver is effective only when it is given in writing and signed by the party that grants it.
These terms, together with the Privacy Policy, form the entire agreement between you and the company about the use of this website, and they replace any earlier arrangement on the same subject.
Section twenty two
Changes to These Terms
We may revise these terms from time to time to reflect a change in our services, a change in the law, or a change in the practice of the laboratory. When we revise the terms, we update the effective date that is shown at the top of this page.
The version that binds you is the version that is current at the time that you use the website or at the time that you place an order, as the situation requires. If we make a change that affects an ongoing relationship in an important way, we will draw your attention to it in the acceptance of a new order or through a notice that points you to this page.
Continuing use of the website after a revision appears counts as your acceptance of the revised terms. If you do not agree with a new version, you should stop using the website and you should not start a fresh order under the terms that you reject.