PeptideDoc · Bayside Queens NY

PeptideDoc FDA Regulatory & Clinical Disclaimers

Master FDA Regulatory Compliance & Disclosure Statement

Dr. Saul Maslavi, MD · Precision Peptide Therapy & Medical Weight Loss · Bayside, NY

FDA-Approved503B SourcedMD-SupervisedPhysician NPI 1134137383

Medical Director

Dr. Saul Maslavi, MD

Practice Location

4232 Francis Lewis Boulevard, Bayside, NY 11361

Web Portal

https://peptidedoc.com/

Effective Date

September 15, 2026

Statutory FDA Mandatory Disclosure (21 U.S.C. § 355 / FD&C Act)

Statements made on peptidedoc.com, in promotional or educational literature, or during clinical consults regarding custom-compounded peptides, peptide secretagogues, weight loss therapies, and adjunctive nutritional supplements have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) for the diagnosis, cure, mitigation, treatment, or prevention of any specific disease or clinical condition.

Regulatory Status of Compounded Peptides & Custom Formulas

Many peptide therapies prescribed at PeptideDoc are custom-compounded formulations prepared pursuant to a valid, individualized physician prescription issued by Dr. Saul Maslavi, MD, and compounded by FDA-registered 503A or 503B outsourcing and compounding pharmacies.

Not mass-market approved new drugs

Individual compounded peptide preparations are prepared for specific patients on a personalized basis and do not undergo New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) pre-market safety or efficacy reviews by the FDA.

Compounded pharmacy governance

All compounding partners utilized or recommended by PeptideDoc operate under state board of pharmacy licensing and federal CGMP (Current Good Manufacturing Practice) standards, yet individual compounds remain legally categorized as compounded drugs rather than FDA-approved manufactured biologics.

Individualized clinical supervision

Compounded peptides are administered solely under direct medical supervision following clinical history review, physical exam, and laboratory diagnostics.

Off-Label Prescribing & Medical Discretion

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), licensed medical doctors (MDs) possess the legal authority to prescribe FDA-approved or compounded substances for off-label uses — uses other than those specifically indicated in official FDA product labeling — when supported by peer-reviewed medical literature, clinical rationale, and professional judgment.

Doctor–patient discretion & informed consent

Certain peptides or metabolic therapeutics utilized in weight loss, tissue repair, or anti-aging care may be prescribed off-label. Patients receive individual risk–benefit counseling and sign explicit informed consent documents prior to initiating treatment.

Medical Weight Loss & GLP-1/GIP Compounding Notice

Medical weight management protocols offered through PeptideDoc may incorporate clinically supervised appetite regulators, metabolic peptides, or compounded GLP-1/GIP receptor agonist formulations. Patients are advised that:

Individual variability

Weight loss and metabolic responses vary significantly by individual, baseline health, adherence, and nutritional context. No specific weight-loss outcome is guaranteed.

Shortages & compounding

When brand-name FDA-approved drugs face official FDA drug shortages, lawfully compounded equivalents may be prescribed pursuant to federal compounding statutes.

Nutritional & Dietary Supplement Regulatory Disclaimer

Any dietary or nutritional supplements, amino acid blends, or nutraceuticals referenced or dispensed through PeptideDoc are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994. These products are intended to support general well-being and are not intended to diagnose, treat, cure, or prevent any disease.

PeptideDoc Risk & Safety Disclosures

Clinical Risks, Side Effects & Compounding Transparency

Transparent Informed Consent Framework for Peptide & Metabolic Care

Clinical Supervisor

Dr. Saul Maslavi, MD

Practice Scope

Peptides & Weight Loss

Location

Bayside, NY (Queens)

Revision Date

September 15, 2026

General & Specific Side Effects of Peptide Therapy

While peptide therapies are generally well-tolerated when administered under physician supervision, all pharmacologic interventions carry potential adverse reactions. Common, less common, and serious risks include:

Peptide category	Common & mild side effects	Potential serious or systemic risks
Growth Hormone Secretagogues (e.g., CJC-1295, Ipamorelin)	Transient injection site redness, mild water retention, flushing, mild lethargy or tingling.	Insulin sensitivity shifts, elevated fasting glucose, fluid retention, or carpal tunnel-like symptoms.
Metabolic & GLP-1/GIP Peptides	Nausea, mild transient fatigue, constipation, abdominal bloating, decreased appetite.	Gallbladder events, acute pancreatitis, severe gastrointestinal hypomotility, or thyroid C-cell warnings.
Tissue & Recovery Peptides (e.g., BPC-157, TB-500)	Local site irritation, mild bruising, temporary headache or lethargy.	Theoretical cellular proliferation concerns in active oncological disease; long-term human data limitations.
Immune & Regulatory Peptides	Low-grade fever sensation, mild immune-modulating injection tenderness.	Unintended autoimmune or inflammatory responses in predisposed patients.

Mandatory Contraindications & Pre-Treatment Screening

Peptide therapy and physician-supervised weight loss are strictly contraindicated for certain patient populations. Prior to prescription release, mandatory baseline screening evaluates for:

Active or historical malignant neoplasms / oncological disease without formal clearance.

Known hypersensitivity or severe allergic response to specific peptide chains or compounding diluents (e.g., benzyl alcohol, sterile water).

Uncontrolled endocrine, renal, hepatic, or cardiovascular pathology.

Pregnancy, active lactation, or plans to conceive within therapeutic windows.

Compounding Pharmacy Transparency & Quality Standards

Dr. Saul Maslavi, MD partners exclusively with accredited 503A and 503B compounding pharmacies that maintain high industry credentials:

Certificate of Analysis (CoA)

Every compound is accompanied by batch-specific third-party analytical testing for sterility, endotoxins, potency, and purity.

Cold-chain & shipping compliance

Thermolabile peptides are packed with medical-grade thermal insulation and temperature-monitoring indicators.

Pharmacist consultation access

Patients are provided direct access to compounding pharmacists for reconstitution, storage, and administration guidance.

Patient reporting obligation

Patients are required to report any unexpected adverse event, severe allergic symptom, or injection-site infection immediately to PeptideDoc at (718) 717-0003 Ext 7 or seek urgent medical care.

PeptideDoc Website Limitations & Acknowledgments

Digital Content Limitations & Patient Acknowledgment

Binding Legal & Regulatory Disclosures for peptidedoc.com

Governing Entity

Dr. Saul Maslavi, MD

Jurisdiction

Queens County, NY

State Medical Board

NYS Office of Professions

Last Updated

September 15, 2026

Website Content & No Medical Advice Disclaimer

All information published across peptidedoc.com — including blog posts, peptide mechanism sheets, weight loss summaries, FAQ modules, and graphics — is provided solely for educational purposes. Reading content on this site does not constitute medical advice, diagnosis, or treatment recommendations.

Emergency medical warning

If you are experiencing a life-threatening medical emergency, severe allergic reaction (anaphylaxis), or acute cardiovascular symptom, call 911 immediately or go to the nearest emergency room. Do not wait for a response through our website or office phone lines.

Testimonials, Results & Outcome Disclaimers

Patient testimonials, before-and-after timelines, or weight-loss case vignettes displayed on peptidedoc.com represent individual clinical experiences. They are not intended as guarantees that any other patient will achieve identical metabolic, body composition, or clinical outcomes.

State Licensing & Jurisdictional Scope of Practice

Dr. Saul Maslavi, MD is licensed to practice medicine within the State of New York. Telehealth consultations and peptide prescriptions are legally restricted to individuals physically located within jurisdictions where Dr. Maslavi holds active medical licensure or where permitted by applicable telemedicine compacts.

Patient Regulatory Acknowledgment & Signature Block

By signing below or submitting an electronic consultation acknowledgment with PeptideDoc, the patient verifies that they have read, understood, and agreed to all FDA non-approval disclaimers, compounded medication notices, off-label prescribing policies, and risk disclosures.

Patient / legal guardian acknowledgment

Patient Printed Full Name

Date of Birth (MM/DD/YYYY)

Digitally Signed / Physical Signature

Patient Signature

Date Executed

PeptideDoc Medical Practice & Regulatory Office

Medical Director

Dr. Saul Maslavi, MD

Office Telephone

(718) 717-0003 Ext 7

Clinical Address

4232 Francis Lewis Boulevard, Bayside, NY 11361

Official Website

https://peptidedoc.com/

Questions about care at PeptideDoc?

Request a physician consultation at our Bayside, Queens medical practice.

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