COMPOUNDED MEDICATION ACKNOWLEDGMENT

ACKNOWLEDGMENT REGARDING COMPOUNDED MEDICATIONS

By accepting this Acknowledgment, you (“Patient,” “I,” or “you”) acknowledge that you understand the nature of compounded medications and consent to receive them as prescribed by a clinician of Black Forest MD of Florida, PLLC (the “Practice”) and dispensed under the Practice’s Florida Dispensing Practitioner authority described in Section 5 below.

This Acknowledgment applies to any compounded medication that may be prescribed and dispensed to you through the Practice, now or in the future. The Practice may, from time to time, request you to execute additional product-specific acknowledgments for individual compounded products that present specific risks or considerations beyond those covered here.

1. WHAT IS A COMPOUNDED MEDICATION?

A compounded medication is a medication that is prepared by a licensed pharmacist or pharmacy in accordance with a specific prescription for an individual patient. Compounding pharmacies are regulated by state boards of pharmacy and, when applicable, by the U.S. Food and Drug Administration (“FDA”) under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

Compounded medications are prepared because:

A specific dose, strength, formulation, route of administration, or delivery method is required that is not available in a commercially manufactured FDA-approved drug
A patient has a documented need (e.g., allergy, intolerance, or absorption issue) that a commercial drug cannot meet
The clinician determines that an individualized preparation is medically appropriate for the patient

2. COMPOUNDED MEDICATIONS ARE NOT FDA-APPROVED

Compounded medications are NOT FDA-approved. This means:

The FDA has not reviewed compounded medications for safety, efficacy, purity, or potency
Compounded medications do not carry FDA-approved labeling
Compounded medications are not subject to the same manufacturing, testing, and quality controls as FDA-approved drugs
The FDA does not require compounded medications to demonstrate effectiveness for any specific medical condition
Compounded medications are not subject to the same adverse event reporting requirements as FDA-approved drugs

By accepting compounded medications, you understand that you are receiving a non-FDA-approved drug product. Your clinician has determined, based on individualized clinical evaluation, that the compounded medication is appropriate for you.

3. WHY YOUR CLINICIAN MAY PRESCRIBE A COMPOUNDED MEDICATION

Your clinician may prescribe a compounded medication when:

No FDA-approved drug exists that meets your specific clinical needs
An FDA-approved drug exists but is not appropriate for you (due to dose, formulation, allergens, or other reasons)
The compounded medication offers an individualized therapeutic approach that aligns with your treatment goals
The compounded medication is widely used in clinical practice for indications that are not addressed by FDA-approved drugs

The decision to prescribe is at the sole discretion of your treating clinician based on their professional medical judgment.

4. RISKS AND POTENTIAL SIDE EFFECTS

As with any medication, compounded medications carry risks and may cause side effects. These vary by medication and route of administration.

General risks of compounded medications

Allergic reactions, ranging from mild (rash, itching) to severe (anaphylaxis)
Adverse drug interactions with other medications, supplements, or foods
Unknown long-term effects (since these products have not undergone FDA review)
Variability in potency or quality between compounding pharmacies
Risks of contamination (microbiological, chemical, or particulate) if pharmacy practices are inadequate
Risks of endotoxin reactions if pharmacy sterility practices fail

Additional risks specific to injectable compounded medications

Injection site reactions (pain, swelling, redness, bruising, infection)
Vascular complications if injection technique is inadequate
Risks of self-injection if instructed to administer at home (see Section 7 below)

Additional risks specific to topical, oral, sublingual, or nasal compounded medications

Absorption variability
Mucosal or skin irritation
Risk of misdosing without standardized FDA-approved measuring devices

5. HOW YOUR PRESCRIPTION IS COMPOUNDED AND DISPENSED

5.1 The Compounding Step

Your prescription is prepared (compounded) by a separately licensed 503A compounding pharmacy that:

Holds appropriate state pharmacy licenses, including a Florida pharmacy permit issued by the Florida Department of Health pursuant to Fla. Stat. Ch. 465
Holds non-resident pharmacy permits for any state into which medication is shipped
Is registered with the FDA as a 503A pharmacy
Maintains compounding practices consistent with USP <795> (non-sterile compounding) and USP <797> (sterile compounding) standards
Complies with sterility testing, endotoxin testing (where applicable), and beyond-use-date documentation requirements

You may request the name and contact information of the compounding pharmacy by emailing [email protected].

5.2 The Dispensing Step

After compounding, your medication is dispensed directly to you by the Practice under its Florida Dispensing Practitioner authority (Fla. Stat. § 465.0276). The treating physician who orders your prescription is registered with the Florida Department of Health as a Dispensing Practitioner and is responsible for the dispensing.

5.3 Your Right to Choose a Different Pharmacy

Florida law (Fla. Stat. § 465.0276) requires us to disclose that you are NOT required to have your prescription dispensed by the Practice. You have the right to have your compounded prescription filled by any other licensed pharmacy of your choosing. If you would prefer to use a different pharmacy, notify your clinician at any time and your prescription will be transmitted accordingly. Exercising this right will not affect your access to any other care or service of the Practice.

5.4 Labeling, Recordkeeping, and Beyond-Use Dates

Each medication dispensed will bear a label identifying the medication, the patient, the prescriber, the dose and directions for use, the date of dispensing, and the beyond-use date. The Practice maintains dispensing records as required by Florida law.

6. STORAGE, HANDLING, AND BEYOND-USE DATES

You agree to:

Store your medication according to the storage instructions on the label (refrigeration where indicated, away from light, away from heat, out of reach of children and pets)
Inspect the shipment when it arrives, including any temperature indicator. If the temperature indicator shows an excursion outside the validated range, do not use the product — contact the clinical team immediately so a replacement can be arranged
Confirm the medication label matches you (your name, date of birth, prescribed dose, and prescriber) before each use
Not use the medication after its beyond-use date
Not transfer the medication into a different container, not share it with another person, and not use it for anyone other than yourself
Dispose of any unused, expired, or contaminated medication safely — do not flush, do not place in regular trash, and follow the disposal instructions provided in your shipment

7. SELF-ADMINISTRATION TRAINING AND SHARPS DISPOSAL

For injectable compounded medications:

You agree to complete the written and video training materials provided by the Practice before administering your first dose.
You agree to follow the administration technique, site rotation, and aseptic practices described in the training materials.
Sharps disposal. Used needles, syringes, pens, or other injection devices must be disposed of in the sharps container provided with your shipment. Used sharps may not be placed in household trash or recycling. When the sharps container is full, follow the disposal instructions provided with the container.

8. ALLERGIES, CONTRAINDICATIONS, AND DISCLOSURES YOU MUST MAKE

It is your responsibility to disclose to your clinician:

All known allergies and adverse reactions to medications, foods, or substances
All current medications, supplements, and recreational substances
All current and past medical conditions, including surgeries, hospitalizations, and chronic conditions
Any changes to the above as they occur

You should NOT begin any compounded medication, and you should notify your clinician immediately, if you experience or develop any of the following:

A known or suspected allergy to the medication or any of its ingredients
A new medication, supplement, or substance you are taking
A new or worsening medical condition
Any symptom that gives you concern

Pregnancy and Breastfeeding

Compounded medications may carry pregnancy and breastfeeding risks that have not been studied as they would be for an FDA-approved drug. You agree to:

Disclose any current or planned pregnancy or any breastfeeding status to your clinician before starting any compounded medication
Notify your clinician immediately if you become pregnant, plan to become pregnant, or begin breastfeeding during treatment

Failure to disclose accurate health information may result in inappropriate prescribing, adverse events, or denial of further care. Liability for adverse outcomes resulting from undisclosed or inaccurate health information is governed by the Limitation of Liability provisions of the Practice’s Terms of Service.

9. INDIVIDUAL EVALUATION REQUIRED

Your clinician will prescribe a compounded medication only if, after individualized evaluation, the clinician determines it is appropriate for you. The clinician may decline to prescribe based on your specific circumstances, including but not limited to: medical contraindications, insufficient information, regulatory restrictions in your state, or clinical judgment.

You may not direct, demand, or insist on a specific prescription. The clinician’s professional judgment is final.

10. NO GUARANTEE OF RESULTS

There is no guarantee that any compounded medication will produce any specific result, benefit, or outcome for you. Individual responses vary substantially. The Practice and your clinician make no representations or warranties regarding outcomes.

Compounded medications are not FDA-approved to treat, cure, prevent, or diagnose any specific disease. You agree not to rely on any compounded medication as a treatment for any specific disease or condition.

11. NO USE FOR UNAPPROVED PURPOSES

You agree not to use compounded medications:

For any purpose other than as prescribed by your clinician
To diagnose, treat, cure, or prevent any specific disease or condition not specifically addressed by your clinician
For any person other than yourself
For resale, redistribution, sharing, or gifting to others

12. SUBSCRIPTION REFILLS AND ACTIVE PRESCRIPTION REQUIREMENT

Compounded medications dispensed through your monthly subscription are prepared in response to your active prescription issued by your treating clinician. You acknowledge that:

Each refill represents a new dispensing event under your active prescription
Your prescription is valid only while you are an active patient of the Practice
Any change to your clinical status (new conditions, new medications, pregnancy, adverse event, etc.) may require your clinician to pause or modify your prescription
Cancellation of your subscription terminates the prescription and you will receive no further shipments

13. PRODUCT-SPECIFIC ADDENDUMS

For certain compounded products, the Practice may require you to execute an additional product-specific acknowledgment that addresses risks, contraindications, dosing, or considerations unique to that product. Such addendums are incorporated into this Acknowledgment by reference once executed.

14. RIGHT TO REFUSE OR WITHDRAW

You may refuse to accept any compounded medication or withdraw consent at any time. Withdrawal will not affect your right to other care or services from the Practice.

15. FLORIDA-SPECIFIC PROVISIONS

15.1 Florida Dispensing Practitioner (Fla. Stat. § 465.0276)

The Practice dispenses compounded medications to you under Fla. Stat. § 465.0276. The treating physician of the Practice is registered with the Florida Department of Health as a Dispensing Practitioner. As required by § 465.0276(2)(b), you have been notified above of your right to choose any other licensed pharmacy.

15.2 Florida Pharmacy Law (Fla. Stat. Ch. 465 and Fla. Admin. Code Ch. 64B16)

The 503A compounding pharmacy that compounds your medication holds a valid Florida pharmacy permit issued under Fla. Stat. Ch. 465 and operates under the supervision of a licensed pharmacist-in-charge (“PIC”). Florida law permits non-pharmacist ownership of pharmacies subject to PIC supervision.

15.3 Florida Drug, Cosmetic, and Household Products Act (Fla. Stat. Ch. 499)

The 503A pharmacy and the Practice operate in compliance with the Florida Drug and Cosmetic Act (Fla. Stat. Ch. 499), including any applicable wholesale-distributor permit and recordkeeping requirements.

16. LANGUAGES AND ACCESSIBILITY

This Acknowledgment is available in English. Upon request, the Practice will provide a Spanish-language version and, where reasonably available, other languages. Patients with limited English proficiency or with disabilities affecting reading, vision, or comprehension may request language assistance services or reasonable accommodation at no cost by emailing [email protected].

17. RELATIONSHIP TO OTHER DOCUMENTS

This Acknowledgment is intended to be read together with, and is supplemented by:

Terms of Service — the contractual terms governing your use of the platform, including the Limitation of Liability and arbitration provisions
Telehealth Informed Consent — your consent to receive care via telehealth
Privacy Policy — the information practices of the Site
HIPAA Notice of Privacy Practices — your HIPAA rights and how the Practice uses your PHI

If a conflict arises between this Acknowledgment and any of those documents on a matter of compounded-medication risks and dispensing specifically, this Acknowledgment governs.

18. ACKNOWLEDGMENT AND CONSENT

By accepting this Acknowledgment (by electronic signature, click-through acceptance, or handwritten signature below), you acknowledge that:

You have read and understood this Compounded Medication Acknowledgment
You have had the opportunity to ask questions
You understand that compounded medications are not FDA-approved
You understand the risks generally associated with compounded medications, including allergic reactions, drug interactions, contamination risks, and unknown long-term effects
You consent to receive compounded medications prescribed by your clinician
You consent to the dispensing of those medications by the Practice under its Florida Dispensing Practitioner authority (Fla. Stat. § 465.0276)
You have been notified of your right to have your compounded prescription filled by any other licensed pharmacy of your choosing
You agree to report adverse events promptly to both your clinician and (for serious events) to FDA’s MedWatch
You agree to store, handle, and dispose of your medication as described in Sections 6 and 7
You agree to complete the training materials before administering any injectable medication (Section 7)
You will provide accurate and complete information about your health, allergies, medications, and pregnancy or breastfeeding status (Section 8)
You understand that the Practice may request additional product-specific acknowledgments for individual compounded products you are prescribed