Research Compliance

1. Definitions

For purposes of this Policy, the following terms have the meanings set forth below:

Research Use Only (RUO): Our sale restriction indicating that products are not FDA-approved and are offered solely for in-vitro laboratory research by qualified users. RUO labeling for in-vitro diagnostic devices is addressed in 21 CFR 809; our products are research chemicals, not IVDs.
In Vitro: Research conducted in a controlled laboratory environment using test tubes, culture dishes, or other artificial environments outside of living organisms.
In Vivo: Research involving administration to or testing in living organisms, including humans and animals. Cosmic Peptides does not support or facilitate in vivo research.
Controlled Substance: A drug or chemical regulated under the federal Controlled Substances Act (21 U.S.C. § 812) and assigned to DEA schedules I-V. We do not sell DEA-scheduled products.
Sanctioned Party/Jurisdiction: Countries, entities, or individuals subject to U.S. economic sanctions administered by the Office of Foreign Assets Control (OFAC), including those on the Specially Designated Nationals (SDN) List and other restricted party lists.

2. Purpose and Scope

This Research Compliance Policy ("Policy") establishes the legal and regulatory framework governing the sale, distribution, and authorized use of research chemical products offered by Cosmic Peptides. This Policy supplements and should be read in conjunction with our Terms of Service and Privacy Policy, which are incorporated herein by reference.

Cosmic Peptides supplies unapproved research chemicals sold solely for in-vitro research by qualified users in appropriate laboratory settings. Our products are not drugs, medical devices, cosmetics, foods, dietary supplements, or veterinary products, and are not evaluated or approved by FDA or any regulator.

AGE RESTRICTION: Our Site, products, and services are intended solely for individuals who are at least eighteen (18) years of age or the age of majority in their jurisdiction, whichever is greater. We do not knowingly sell products to, collect information from, or market to individuals under the age of 18.

This Policy serves to:

Educate customers on applicable legal and regulatory requirements
Clarify prohibited uses and activities
Establish customer qualification and verification standards
Define our compliance procedures and enforcement mechanisms
Protect public health and safety by preventing product misuse
Demonstrate our commitment to regulatory compliance and responsible commerce

3. Research Use Only (RUO) - Sale Restrictions and Requirements

3.1 What "Research Use Only" Means

RUO products sold by Cosmic Peptides are intended ONLY for:

In vitro (test tube/culture dish) laboratory experiments and assays
Analytical method development and validation
Chemical characterization and reference standard preparation
Academic and institutional research studies not involving human or animal subjects
Quality control testing and assay development
Biochemical and molecular biology research applications
Educational demonstrations in properly equipped laboratory settings

3.2 What RUO Does NOT Permit

RUO designation explicitly PROHIBITS the following uses:

Human Use: Consumption, ingestion, injection, topical application, inhalation, or any other form of human administration or exposure
Veterinary Use: Administration to animals for therapeutic, diagnostic, or performance-enhancement purposes
Clinical Applications: Use in clinical trials, medical treatment, disease diagnosis, or patient care
Drug Compounding: Formulation or compounding of prescription medications, over-the-counter drugs, or pharmaceutical preparations
Dietary Supplements: Incorporation into nutritional supplements, sports nutrition products, or food additives
Cosmetic Products: Use in personal care products, cosmetics, or beauty preparations intended for human application
Therapeutic Claims: Marketing or distribution with health claims, medical benefits, or therapeutic efficacy statements
In Vivo Research: We do not support in vivo research; orders suggesting in vivo use will be refused

4. Regulatory Framework

4.1 Federal Regulations

The sale and use of research chemicals are governed by multiple federal regulatory frameworks:

Federal Food, Drug, and Cosmetic Act (FDCA):

Prohibits introduction into interstate commerce of any drug, device, cosmetic, or food additive that is adulterated or misbranded.
Defines "new drug" and requires FDA approval before marketing drugs for human or animal use
Our products have NOT received FDA approval and may NOT be marketed or distributed as drugs

Controlled Substances Act (CSA):

Establishes schedules (I-V) for controlled substances based on abuse potential and accepted medical use
Requires DEA registration for manufacture, distribution, or dispensing of controlled substances
We do not sell DEA-scheduled products; suspected attempts to purchase scheduled substances will be refused and may be reported to authorities

Prescription Drug Marketing Act (PDMA):

Prohibits unauthorized distribution of prescription drug samples
Cosmic Peptides does NOT distribute prescription drugs or drug samples

Dietary Supplement Health and Education Act (DSHEA):

Regulates dietary supplements and establishes labeling requirements
Products sold by Cosmic Peptides are NOT dietary supplements and may NOT be marketed as such

4.2 Export Control and Sanctions

Export Administration Regulations (EAR): Administered by the Bureau of Industry and Security (BIS), U.S. Department of Commerce. Certain chemical compounds may require export licenses. Civil and criminal penalties may apply for violations.

Office of Foreign Assets Control (OFAC) Sanctions: Buyers must comply with U.S. export controls and sanctions. We screen against OFAC SDN and other U.S. restricted party lists, including the BIS Entity List/MEU List, and do not transact with sanctioned parties or destinations. Sanctions lists change frequently; customers are responsible for ensuring ongoing compliance.

Export and Re-Export Prohibition: Customers may not export, re-export, or transfer our products outside the United States. Attempts to procure for export or to route shipments through reshippers for export will be refused and may be reported to appropriate authorities.

4.3 Environmental and Safety Regulations

Handling, storage, and disposal of research chemicals are subject to environmental and occupational safety regulations:

Occupational Safety and Health Administration (OSHA):

Hazard Communication Standard requires chemical safety training, labeling, and Safety Data Sheets (SDS)
Personal Protective Equipment standards establish PPE requirements for chemical handling
Laboratory Safety Standard establishes requirements for laboratory chemical hygiene plans

Environmental Protection Agency (EPA):

Resource Conservation and Recovery Act (RCRA) governs hazardous waste identification, storage, and disposal
Toxic Substances Control Act (TSCA) regulates manufacture and use of chemical substances
Customers are responsible for proper disposal of chemical waste in accordance with federal, state, and local environmental regulations

4.4 State and Local Regulations

In addition to federal law, research chemicals are subject to state and local regulations including:

State pharmacy practice acts and regulations governing drug distribution
State controlled substances laws and analog statutes
State consumer protection and deceptive trade practice laws
Local zoning, fire, and safety codes governing chemical storage facilities
Institutional biosafety and chemical safety policies at universities and research organizations

5. What Cosmic Peptides Is NOT

To ensure regulatory compliance and customer understanding, we explicitly state what Cosmic Peptides is NOT:

5.1 NOT a Compounding Pharmacy (503A)

Cosmic Peptides is NOT a compounding pharmacy as defined under Section 503A of the Federal Food, Drug, and Cosmetic Act. We do NOT compound prescription medications, prepare patient-specific formulations, provide dosing instructions, operate under state pharmacy board licensure, or maintain USP compliant compounding facilities.

5.2 NOT an Outsourcing Facility (503B)

Cosmic Peptides is NOT an outsourcing facility as defined under Section 503B of the Federal Food, Drug, and Cosmetic Act. We do NOT register with FDA as an outsourcing facility, compound drugs under cGMP, or produce sterile compounded preparations for healthcare facilities.

5.3 NOT a Pharmaceutical Manufacturer

We do NOT manufacture drugs subject to FDA approval requirements. We do NOT hold New Drug Applications (NDAs), operate under FDA-registered drug manufacturing establishment regulations, or make health claims or therapeutic efficacy representations for our products.

5.4 NOT a Medical Provider or Healthcare Entity

We do NOT provide medical services, advice, or treatment. We are not a HIPAA covered entity; see our Privacy Policy for information on data practices. We do NOT diagnose, treat, cure, or prevent any disease, provide medical advice, recommend products for medical conditions, prescribe medications, or operate as a healthcare provider subject to state medical practice laws.

5.5 NOT a Dietary Supplement Manufacturer

Our products are NOT dietary supplements, nutritional supplements, or food additives. We do NOT market products for ingestion, make structure/function claims, comply with dietary supplement regulations under DSHEA, or represent products as safe for human consumption.

6. Customer Qualification and Verification Requirements

6.1 Who May Purchase

Cosmic Peptides is committed to making research accessible to qualified individuals and organizations conducting legitimate scientific investigation. Products may be purchased by:

Academic and research institutions (universities, colleges, research centers)
Government research laboratories and agencies
Private research organizations and contract research organizations (CROs)
Biotechnology and pharmaceutical companies conducting legitimate research
Individual researchers affiliated with recognized institutions
Independent researchers with appropriate facilities conducting lawful scientific investigation
Educational purchasers for classroom demonstrations and teaching purposes
Analytical testing laboratories and quality control facilities
Qualified individuals with demonstrated expertise in relevant scientific fields

We recognize that valuable scientific research occurs in diverse settings, including independent laboratories and private research facilities. We are committed to supporting legitimate scientific inquiry while maintaining our responsibility for regulatory compliance and appropriate use verification.

6.2 Customer Verification Process

We use a risk-based verification approach. Factors may include order value, quantity, product risk, shipping pattern, and account history. We may request lab details, credentials, and end-use attestations. Verification requirements are illustrative and may be adjusted based on risk assessment:

Standard Orders (Lower Risk Profile):

Basic account information and identity verification
Acknowledgment of Terms of Service and RUO restrictions
Valid shipping address
Payment from verifiable source matching customer information

Enhanced Verification (Higher Risk Profile):

Orders exhibiting higher risk characteristics may require enhanced verification, which may include:

Research Purpose: Description of intended research application and scientific rationale
Facility Information: Description of laboratory setup, safety equipment, and storage capabilities
Credentials: Academic degrees, professional licenses, research publications, or demonstrated expertise in relevant field
Institutional Affiliation: Verification of employment or affiliation (where applicable)
Identity Verification: Government-issued identification matching billing and shipping information
End-Use Certification: Written attestation of RUO compliance and acknowledgment of prohibited uses
Additional Documentation: As reasonably requested to verify legitimacy and compliance

We may accept alternative forms of verification including research portfolios, published work, or demonstrated knowledge of safe handling practices. The specific verification requirements will be communicated to you at the time of order review, and orders will be held pending verification.

Repeat Customer Verification: Established customers with verified accounts and compliant order history may be exempt from enhanced verification for subsequent orders, provided that order patterns remain consistent with verified research purposes and do not exhibit suspicious characteristics.

6.3 Prohibited Purchasers and Restricted Circumstances

We reserve the right to refuse sales in the following circumstances:

Freight Forwarders/Reshippers: No freight forwarders or reshippers without enhanced verification and a legitimate research use case
P.O. Boxes: We do not ship to P.O. Boxes, except where required by carrier constraints and only after enhanced verification
Bulk Orders Without Verification: Large quantity orders require enhanced verification; refusal to provide verification information will result in order cancellation
Suspected Unauthorized Distribution: Entities or individuals suspected of engaging in unauthorized resale, compounding, or distribution activities
Sanctioned Parties/Jurisdictions: Individuals or entities in sanctioned jurisdictions or on restricted party lists
Compliance Violations: Customers with documented history of RUO violations, fraudulent activity, or misuse of products
Refused Verification: Customers who refuse to provide requested verification information appropriate to their order risk profile
Suspicious Activity: Orders exhibiting red flags such as false information, payment irregularities, inconsistent shipping patterns, or requests inconsistent with stated research purpose

6.4 Account Denial Appeals and Re-Verification

If your account or order is denied, you may submit an appeal by contacting legal@cosmicpeptides.com with additional documentation or clarification. Appeals are aimed to be reviewed within five (5) business days. Denied accounts may request re-verification after six (6) months by submitting updated credentials and documentation demonstrating eligibility.

7. Compliance Monitoring and Enforcement

7.1 Order Monitoring

We employ compliance monitoring procedures to detect and prevent product misuse, including:

Automated screening of orders for suspicious patterns or high-risk indicators
Manual review of orders exhibiting enhanced risk characteristics
Geographic analysis to identify shipments to high-risk or sanctioned jurisdictions
Customer behavior monitoring for repeat violations or suspicious activity
Third-party data verification and enhanced due diligence for high-risk customers
Screening against OFAC SDN and other restricted party lists

7.2 Red Flags and Suspicious Activity

The following activities may trigger additional scrutiny, order cancellation, or account suspension:

Orders placed using false, incomplete, or unverifiable information
Requests for express or overnight shipping to residential addresses
Payment from sources that do not match customer name or institutional affiliation
Large quantity orders inconsistent with stated research purpose
Requests for products without analytical documentation or COAs
Communication requesting dosing information, administration guidance, or therapeutic advice
Attempts to remove or alter product labels or documentation
Resale or redistribution to unauthorized parties
Multiple accounts or orders from same individual or address
User-generated content (reviews, comments, messages) implying human use or therapeutic applications

7.3 Enforcement Actions

We may cancel orders, suspend accounts, require enhanced verification, place shipment holds, and where appropriate report suspected illegal activity to regulators or law enforcement. Specific actions may include:

Order Cancellation: Immediate cancellation and refund of pending orders
Account Suspension: Temporary or permanent suspension of customer account and purchasing privileges
Enhanced Verification: Requirement for additional documentation, credentials, or institutional verification
Shipment Hold: Delay or refusal of shipment pending investigation and verification
Regulatory Notification: Reporting of suspected illegal activity where appropriate
Legal Action: Pursuit of remedies for fraud, misrepresentation, or violations of Terms of Service
Content Removal: We remove or decline user-generated content implying human use; repeat violations result in account termination

7.4 Data Retention for Compliance

We retain customer verification records (KYC), order review notes, red-flag decisions, and compliance documentation for a minimum of five (5) years from the date of the last transaction, or longer if required by law or regulatory guidance. This supports our compliance monitoring, regulatory cooperation, and fraud prevention efforts.

8. Customer Responsibilities

8.1 Legal Compliance Obligations

Customers are solely responsible for ensuring compliance with all applicable laws and regulations, including:

Obtaining all necessary permits, licenses, and authorizations required in their jurisdiction
Complying with institutional biosafety, chemical safety, and research oversight requirements
Maintaining proper recordkeeping, storage, and security for research chemicals
Implementing appropriate safety protocols and personal protective equipment
Training personnel on safe handling, storage, and disposal procedures
Reporting adverse events, safety incidents, or compliance violations to appropriate authorities
Ensuring products are not diverted to unauthorized uses or users

8.2 Institutional Review and Approval

Customers affiliated with institutions must comply with institutional policies. We do not support in vivo research; orders suggesting in vivo use will be refused. Institutional approvals that may be relevant include:

Institutional Biosafety Committee (IBC) approval for biohazardous materials
Environmental Health and Safety (EHS) approval for chemical procurement and use
Institutional Chemical Hygiene Plan compliance

Institutional approvals do not override our prohibition on in vivo research or any other restrictions in this Policy.

8.3 Storage and Handling Requirements

Customers must implement proper storage and handling procedures including:

Storing products at manufacturer-recommended temperature and humidity conditions
Maintaining segregation from incompatible chemicals
Implementing security measures to prevent unauthorized access or theft
Using appropriate containers, labels, and secondary containment
Maintaining inventory records and chain of custody documentation
Inspecting products regularly for degradation, contamination, or damage

8.4 Disposal Obligations

Customers must dispose of products and waste materials in accordance with applicable regulations:

Classify waste properly under RCRA hazardous waste regulations
Segregate chemical waste by compatibility and hazard class
Use licensed hazardous waste contractors for disposal
Maintain waste manifests and disposal documentation
Comply with state and local environmental regulations
Never dispose of research chemicals by pouring down drains, placing in regular trash, or releasing to environment

9. Product Labeling and Documentation

9.1 Required Labeling

All products are labeled with the following information:

Product name and chemical identity
CAS No. (where applicable)
Lot or batch number
Net contents (mass/volume)
Quantity or concentration
Storage conditions and expiration or retest date
"FOR RESEARCH USE ONLY" statement
Hazard warnings and precautionary statements
Manufacturer information and contact details

9.2 Certificates of Analysis (COA)

Each product lot is accompanied by a Certificate of Analysis containing:

Analytical test results (purity, identity, potency)
Test methods and specifications
Lot-specific data and quality control information
Release date and expiration or retest date

COAs are provided for informational purposes and do NOT constitute a warranty of fitness for any particular purpose or representation that products are suitable for therapeutic use.

10. Prohibited Representations and Marketing

10.1 No Therapeutic Claims

Customers are prohibited from making therapeutic claims, health benefit statements, or medical efficacy representations regarding products, including:

Statements that products diagnose, treat, cure, or prevent any disease
Claims regarding therapeutic effects, health benefits, or medical outcomes
Representations that products are safe or effective for human or animal use
Structure/function claims or nutritional benefit statements
Testimonials or endorsements suggesting medical or therapeutic use

10.2 No Unauthorized Distribution

Customers are prohibited from:

Reselling or redistributing products to unauthorized parties
Marketing products for human consumption or therapeutic use
Removing, altering, or obscuring RUO labels or warnings
Repackaging products without maintaining original labeling and documentation
Advertising products on platforms or in contexts suggesting non-research uses

10.3 Prohibited User-Generated Content

We explicitly prohibit and will remove user-generated content (reviews, comments, forum posts, messages) that:

Requests or provides dosing information, administration guidance, or therapeutic advice
Implies human use, self-administration, or therapeutic applications
Makes health claims, medical efficacy statements, or personal testimonials regarding effects
Discusses sourcing products for non-research purposes
Violates our Terms of Service or this Policy

Repeat violations of content policies will result in account termination.

11. Reporting Obligations

11.1 Adverse Events and Safety Issues

Customers must immediately report to us any:

Unexpected safety incidents involving products
Product quality defects, contamination, or degradation
Suspected counterfeit or adulterated products
Security incidents including theft, loss, or unauthorized access
Regulatory inquiries or enforcement actions related to products

11.2 Suspected Violations

If you become aware of unauthorized use, misuse, or diversion of products purchased from Cosmic Peptides, you must immediately report such activity to legal@cosmicpeptides.com.

12. Consistency with Terms of Service

This Research Compliance Policy is consistent with and supplements our Terms of Service. Key provisions include:

Domestic Shipping Only: We ship only to addresses within the United States and its territories (see Terms Section 5.2)
Export/Re-Export Prohibition: Products may not be exported or re-exported outside the United States (see Terms Section 5.3)
All Sales Final: Due to the nature of research chemicals, all sales are final except as required by law (see Terms Section 7.1)
Chargeback Process: Customers must follow dispute resolution process before initiating chargebacks (see Terms Section 4.8)
Account Termination: We may terminate accounts for violations of these policies (see Terms Section 12)
Age Restriction: Users must be 18+ (see Terms Section 1)
No Medical Claims: Products are not intended for medical use and we do not make therapeutic claims

For remedies related to policy violations, see our Terms of Service. This Policy does not restate provisions contained in the Terms.

13. Limitation of Liability and Disclaimers

13.1 No Warranties for Specific Applications

We make NO representations or warranties that products are suitable for any specific research application, will produce particular research outcomes, or are appropriate for any particular purpose. Products are provided "AS IS" for general research use only.

13.2 Customer Assumption of Risk

By purchasing products, you acknowledge and agree that:

You assume all risks associated with purchase, possession, storage, handling, use, and disposal
You are solely responsible for determining suitability of products for your intended research application
You will not hold Cosmic Peptides liable for any injury, illness, death, property damage, or other harm resulting from product use or misuse
You have the knowledge, training, and facilities necessary to safely handle research chemicals

13.3 Indemnification

You agree to indemnify and hold harmless Cosmic Peptides from any claims, damages, or liabilities arising from your violation of this Policy, misuse of products, or violation of applicable laws. See Section 9 of our Terms of Service for complete indemnification provisions.

14. Related Policies and Additional Information

14.1 Governing Documents

This Research Compliance Policy should be read in conjunction with:

Terms of Service - Complete legal terms governing use of our Site and purchase of products
Privacy Policy - Information on how we collect, use, and protect customer data
Shipping Policy - Shipping terms, delivery requirements, and compliance

14.2 External Resources

For additional information on regulatory compliance, consult:

15. Policy Updates and Modifications

We reserve the right to modify this Research Compliance Policy at any time to reflect changes in applicable laws, regulations, or our business practices. Material changes will be communicated by posting the updated Policy on our Site with a new "Effective Date" and Policy ID. Your continued purchase or use of products after policy updates constitutes acceptance of the revised Policy.

16. Contact Information for Researchers

For questions regarding this Research Compliance Policy, verification requirements, or to report compliance concerns, please contact:

Cosmic Peptides Compliance Department
Email: legal@cosmicpeptides.com
Mailing Address: 10730 Potranco Rd Ste 122, San Antonio, TX 78251

Response Time: We aim to respond to compliance inquiries within five (5) business days. Urgent matters will be prioritized.

17. Acknowledgment

BY PURCHASING PRODUCTS FROM COSMIC PEPTIDES, YOU ACKNOWLEDGE THAT:

You have read and understood this Research Compliance Policy in its entirety
You agree to comply with all applicable laws, regulations, and institutional policies
You will use products exclusively for lawful in vitro research purposes
You possess the necessary qualifications, training, and facilities to safely handle research chemicals
You will NOT use products for human consumption, therapeutic purposes, or any unauthorized application
You understand the legal consequences of RUO violations and product misuse
You assume all risks associated with purchase, possession, and use of products
You will immediately report any suspected violations or safety incidents to Cosmic Peptides

Failure to comply with this Policy constitutes a material breach of our Terms of Service and may result in account termination, order cancellation, and referral to appropriate authorities where warranted.