503A Compounding Disclosure

1. Who is involved in your care

Three independent parties are involved in the Crystal Clear ecosystem. It matters that you understand who does what.

• Crystal Clear RX Wellness (the MSO). Crystal Clear is a Delaware series limited liability company that operates the Site and provides administrative, marketing, account, membership, and technology services. We are not a pharmacy, we are not a healthcare provider, and we do not prescribe or dispense medications.
• The Provider. Clinical care, including the decision to prescribe a compounded medication, is provided by independent licensed clinicians who use the third-party telehealth platform Qualiphy (the “Telehealth Platform”). Each Provider is an independent contractor, not an employee of Crystal Clear, and exercises their own clinical judgment under their own licensure, training, and applicable law.
• The Partner Pharmacy. When a Provider issues a prescription, the medication is compounded and dispensed by Precision Pharma Corp at 555 Heritage Drive, Lab 143, Jupiter, FL 33458. The Partner Pharmacy is a separately licensed entity, responsible for compounding, dispensing, labeling, packaging, shipping, and pharmacy-related recordkeeping under its own licensure, insurance, and applicable law.

2. What Section 503A actually means

Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353a) governs the traditional pharmacy compounding of human drugs. In practice, that means:

• A licensed pharmacist or physician compounds a drug product for an individually identified patient, based on a valid prescription for that patient.
• The compounding happens in a state-licensed pharmacy, following applicable USP standards (USP <795> for non-sterile, USP <797> for sterile) and applicable state pharmacy law.
• Compounded drug products are exempt from certain provisions that apply to FDA-approved manufactured drugs. That includes new drug approval, current good manufacturing practice (cGMP), and FDA-approved labeling requirements.

3. Compounded medications are not FDA-approved

This is the most important point. Compounded medications are not approved by the FDA. The FDA has not evaluated the safety, effectiveness, or quality of any compounded preparation the way it evaluates commercially manufactured drugs. It does not approve compounded preparations, and it does not certify the labeling, the dosing, or any claims made about them.

Compounded medications are also not generic equivalents of commercially manufactured drugs. They are not interchangeable substitutes for FDA-approved products, and they should not be marketed or relied on as such.

4. Patient-specific compounding

Compounded medications dispensed in connection with the Services are prepared for an individually identified patient, based on a valid prescription issued by a licensed Provider after evaluation. They are not produced for office stock, anticipatory inventory, or wholesale distribution under Section 503A.

Provider memberships purchased on behalf of a healthcare provider’s patient panel are administered to support patient-specific prescriptions for individually identified patients. Crystal Clear and the Partner Pharmacy do not dispense bulk or office-use compounded preparations under Section 503A.

5. Specific categories

5.1 Compounded peptides

Many peptides offered through the Services (depending on availability and on a Provider’s prescription, including some used in longevity, recovery, and metabolic protocols) are not approved by the FDA as drug products. They are not the subject of FDA-approved labeling. The FDA, state regulators, and independent pharmacy boards categorize some peptides in ways that affect their compounding eligibility, and those classifications can change. The Partner Pharmacy will not compound a preparation that, in its professional judgment and under applicable law, may not lawfully be compounded under Section 503A. Available peptides may change without notice.

5.2 Compounded GLP-1 medications

Compounded versions of GLP-1 receptor agonists (semaglutide, tirzepatide, and the like) are not FDA-approved. They are not therapeutic equivalents of any commercially manufactured GLP-1 product. Compounded GLP-1 preparations are dispensed only when permitted under Section 503A and applicable FDA enforcement positions. That may include, where applicable, the appearance of the active ingredient on the FDA Drug Shortage List, or a determination by the Provider, based on the patient’s clinical needs, that there is a clinically significant difference between the compounded preparation and the commercially available product (for example, a different strength, dosage form, or excipient profile required for the patient). The regulatory status of compounded GLP-1 preparations is evolving, and availability can change without notice. Talk to your Provider about the risks, benefits, alternatives, and current regulatory status before starting any compounded GLP-1 medication.

5.3 Other compounded injectables

Other compounded injectables dispensed through the Services are also compounded under Section 503A, for an individually identified patient, pursuant to a valid prescription. They are not FDA-approved. The same general considerations described in this Disclosure apply.

5.4 NanoNAD and NAD+ formulations

NAD+ and related formulations dispensed through the Services are compounded preparations, not FDA-approved drug products. Claims about bioavailability, absorption, or specific health benefits have not been evaluated by the FDA. Discuss the risks, benefits, and alternatives with your Provider before use.

6. Risks

Every medication carries risk, whether it is commercially manufactured or compounded. The risks associated with using compounded medications may include, but are not limited to:

• Allergic or hypersensitivity reactions.
• Injection-site reactions, including pain, redness, swelling, bruising, or infection.
• Systemic side effects, depending on the preparation and on the patient. These may involve the cardiovascular, gastrointestinal, endocrine, neurological, hepatic, or renal systems.
• Sterility failure, including bloodstream infection, despite the application of USP <797> standards.
• Potency variation, since compounded preparations are not subject to the same large-scale stability and uniformity testing as FDA-approved manufactured drugs.
• Drug-drug interactions, contraindications, and underlying conditions that may not be apparent without a thorough medical evaluation.
• Risks associated with off-label use of an active ingredient, including risks that may not be fully understood given the limited clinical data on some compounded ingredients.

Your Provider is responsible for evaluating these risks in the context of your individual health history and discussing them with you before prescribing any compounded medication. Read the labeling from the Partner Pharmacy carefully, follow your Provider’s instructions, and contact your Provider promptly if you experience anything concerning.

7. Sterility, quality, and testing

The Partner Pharmacy operates as a state-licensed 503A pharmacy and represents that it follows applicable USP standards, including USP <797> for sterile compounding, applicable state pharmacy regulations, and its own internal quality program. The Partner Pharmacy is solely responsible for the compounding, sterility assurance, beyond-use dating, labeling, and quality of every compounded preparation it dispenses. Crystal Clear does not compound, test, or release any preparation. We make no independent representation about the sterility, potency, purity, or quality of any compounded medication.

8. Reporting adverse events

If you think you have experienced an adverse event, a side effect, or a quality issue with a compounded medication, do the following:

• If this is a medical emergency, call 911 or go to the nearest emergency room immediately.
• Contact your Provider through the Telehealth Platform to report what happened and to get clinical guidance.
• Report the event to the Partner Pharmacy by calling Precision Pharma Corp at (561) 941-3900.
• Notify Crystal Clear at sales@ccrxpharm.com or (813) 215-2818, so we can coordinate with the Telehealth Platform and the Partner Pharmacy as appropriate.
• Report to the FDA through the FDA MedWatch program at fda.gov/safety/medwatch, or by calling 1-800-FDA-1088.

9. Insurance and cost

Compounded medications dispensed through the Services are generally not covered by health insurance, Medicare, Medicaid, or other federal or state healthcare programs. We do not bill insurance. You are responsible for the full cost of any membership, consult, or compounded medication. We do not warrant or represent that any portion of the cost will be reimbursed by any insurer or program.

10. No substitution; off-label use

A compounded preparation is not a substitute for, and is not interchangeable with, any FDA-approved drug. Do not substitute a compounded preparation for an FDA-approved medication unless your Provider expressly tells you to. Some compounded preparations contain active ingredients that may be used “off-label”, meaning for indications, in dosages, or in patient populations not described in any FDA-approved labeling. Off-label use is a clinical decision your Provider makes based on your individual situation. If your Provider is recommending off-label use, ask them about the basis for it.

11. Patient acknowledgment

By enrolling in a membership, requesting a consult, or accepting a compounded medication dispensed in connection with the Services, you acknowledge and agree that:

• You have read and understand this Disclosure.
• You understand that compounded medications are not FDA-approved and are not generic equivalents of FDA-approved drugs.
• You understand that Crystal Clear is not a pharmacy or healthcare provider, and that clinical and pharmacy services are delivered by independent third parties.
• You have had, or will have, the chance to discuss the risks, benefits, alternatives, and uncertainties of any compounded medication with your Provider before you use it.
• You agree to report any adverse event or quality concern as described in Section 8.

12. Updates to this Disclosure

Federal and state regulatory positions on compounding (including the compounding of peptides and GLP-1 medications) are evolving. We will update this Disclosure from time to time to reflect changes in law, regulation, FDA enforcement positions, or our own practices. The most current version is posted on the Site. The “Last Updated” date at the top tells you when it was last revised.

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