Frequently Asked Questions

Xseer Pharmaceuticals® is a Los Angeles-based pharmaceutical manufacturing partner serving healthcare providers, pharmaceutical companies, biotechnology innovators, and research organizations. We operate through two complementary business lines: an FDA-registered 503B outsourcing facility supplying office-use sterile compounded products to qualified healthcare facilities, and a pharmaceutical CDMO providing integrated development, testing, manufacturing, packaging, and commercialization support. Across both business lines, Xseer combines scientific rigor, disciplined quality systems, technical expertise, and transparent partnerships to advance patient care and therapeutic innovation.

Xseer operates through two complementary business lines: 503B Outsourcing Facility: We manufacture and supply office-use sterile compounded products to qualified healthcare facilities. Contract Development and Manufacturing Organization (CDMO): We support pharmaceutical and biotechnology companies with formulation development, analytical development and testing, technology transfer, clinical manufacturing, packaging, CMC support, and commercial-scale production.

Our 503B division serves qualified clinics, physician practices, infusion centers, pharmacies, hospitals, health systems, and other appropriately licensed healthcare organizations. Our CDMO and laboratory services support pharmaceutical companies, biotechnology companies, virtual development teams, research institutions, clinical research organizations, product sponsors, and other qualified industry partners.

A 503B outsourcing facility is a pharmaceutical compounding facility registered with the U.S. Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act. A registered outsourcing facility may compound and distribute eligible drug products for healthcare-facility use without receiving a patient-specific prescription for every unit, provided that applicable Section 503B requirements are satisfied. Outsourcing facilities are subject to current Good Manufacturing Practice requirements, FDA inspection, product reporting, adverse-event reporting, and other applicable federal requirements.

Office-use products are ordered and maintained by a healthcare facility for administration by qualified healthcare professionals within their practice or facility. The product is supplied directly to the healthcare organization rather than sold to an individual patient or consumer.

A patient-specific prescription is generally not required for an eligible office-use order supplied under Section 503B. The purchasing healthcare facility remains responsible for prescribing, storing, administering, documenting, and otherwise handling the product in accordance with applicable laws, professional standards, and facility policies.

Xseer supplies 503B products only to qualified healthcare organizations whose facility, business, and professional credentials have been reviewed and approved. Eligible organizations may include: Medical clinics Physician practices Infusion centers Medical wellness practices Pharmacies Hospitals Health systems Other appropriately licensed healthcare facilities Authorized healthcare purchasing organizations Eligibility is determined through Xseer’s registration and verification process.

No. Xseer does not sell 503B products directly to individual patients or consumers. Patients should consult a licensed healthcare professional regarding diagnosis, treatment, dosage, administration, and whether a particular medication is clinically appropriate.

Qualified California healthcare facilities can create an account directly through the registration page on the Xseer Pharmaceuticals website. The online registration process collects the organization, facility, contact, and licensing information required to determine purchasing eligibility.

Required information may vary by organization type but can include: Authorized representative information Legal organization or facility name Facility type Professional or facility license information NPI or other applicable healthcare identifiers Supporting business or regulatory documentation Submitted information should match the organization’s official business and licensing records.

Xseer supplies 503B products only to qualified healthcare organizations. Verification helps confirm purchasing eligibility and supports appropriate account controls, regulatory documentation, approved shipping destinations, product distribution, and account security.

Xseer reviews the submitted organization, facility, contact, and licensing information. If the information is complete and verifiable, the account can proceed through approval and activation. Xseer may request corrections or additional documentation when information is incomplete, inconsistent, or cannot be verified. Submitting a registration does not automatically establish purchasing eligibility.

Confirm that the submitted information matches the applicable official records, including: Legal organization name License holder name Professional or facility license number Issuing state NPI or other healthcare identifier, when applicable If the information is accurate but verification remains unsuccessful, contact Xseer for registration support and provide any requested documentation.

Xseer will notify the authorized account representative after the registration review has been completed. Once approved and activated, the customer can sign in to the Xseer Customer Portal and access the purchasing functions available to the account.

Xseer’s 503B product portfolio is designed to evolve with the needs of healthcare providers and patients. Our current sterile injectable portfolio includes: L-Arginine Injection L-Carnitine Injection Cyanocobalamin Injection Hydroxocobalamin Injection Methylcobalamin Injection NAD+ Injection Glutathione Injection This list represents Xseer’s current portfolio and is not intended to be permanent or exhaustive. We expect to introduce additional products and may revise our product offering as clinical demand, product availability, manufacturing priorities, regulatory requirements, and recognized drug shortages change. Our long-term objective is to support healthcare facilities with reliable access to high-demand and difficult-to-source medications where Xseer can establish the appropriate formulation, manufacturing process, testing program, quality controls, and regulatory basis. Products are introduced according to manufacturing schedules, required testing, Quality Unit review, and final release. A product’s appearance on the website does not necessarily mean that it is currently available for immediate ordering. Approved customers should refer to the Xseer Customer Portal for current product availability.

No. Product availability is lot-specific and may change according to manufacturing schedules, required testing, Quality Unit review, material availability, customer demand, and current inventory. Approved customers should use the Customer Portal to review current ordering availability.

A product becomes available only after the applicable manufacturing activities, analytical and microbiological testing, documentation review, and Quality Unit release have been completed. No product can be distributed before its applicable release requirements have been satisfied.

Approved customers place standard 503B orders through the Xseer Customer Portal. After signing in, customers can review available products, select products and quantities, confirm the approved shipping destination, review applicable order information, and submit the order through their account.

Xseer currently accepts and fulfills 503B product orders for approved healthcare facilities located in California. This limitation applies to Xseer’s current 503B product distribution. CDMO and laboratory projects are evaluated separately according to project scope and applicable requirements.

Orders within the eligible Los Angeles delivery area are delivered through Rx2Go. The applicable delivery service, destination eligibility, and delivery details are confirmed during order processing.

Orders to approved healthcare facilities elsewhere in California are shipped through FedEx. The appropriate FedEx service and handling process are selected according to the product, destination, and applicable shipping requirements.

No. Xseer currently limits 503B product distribution to approved healthcare facilities located in California. Additional states may be added after the applicable licensing, operational, and distribution requirements have been completed.

Available tracking or delivery information will be provided after the order has been prepared for FedEx shipment or Rx2Go delivery. Customers are responsible for ensuring that the authorized receiving contact, facility address, and delivery information are accurate.

Quality is integrated into material control, formulation, manufacturing, environmental monitoring, testing, documentation, release, storage, and distribution. Xseer’s quality framework includes dedicated Quality Unit oversight, controlled procedures, trained personnel, lot traceability, formal investigations, analytical and microbiological testing, and documented review before product release.

Product release is controlled through Xseer’s Quality Unit. The Quality Unit reviews applicable manufacturing documentation, testing results, specifications, deviations, investigations, labeling, and supporting records before approving a lot for distribution.

Beyond-use dates are established using product-specific data, stability studies, container-closure considerations, applicable standards, labeled storage conditions, and approved quality procedures. Customers must follow the beyond-use date and storage instructions stated on the product label.

Product-specific storage and handling requirements appear on the product label and applicable supporting documentation. The receiving facility is responsible for maintaining the required storage conditions and protecting the product from unauthorized access, damage, contamination, or temperature excursions.

Xseer provides integrated pharmaceutical development and manufacturing support from early formulation through clinical and commercial readiness. Services may include: Pre-formulation studies Formulation development and optimization Analytical method development and validation Stability programs Technology transfer Process development and scale-up Sterile and non-sterile manufacturing Aseptic fill-finish Clinical trial material manufacturing Clinical packaging and labeling CMC strategy and documentation Commercial manufacturing support The final scope is established according to the product, development stage, regulatory pathway, technical requirements, and commercial objectives.

Xseer evaluates projects from emerging biotechnology companies, pharmaceutical companies, virtual biotechnology teams, product developers, research institutions, clinical research organizations, academic organizations, and established commercial sponsors. Each opportunity is evaluated for technical alignment, capacity, regulatory fit, project readiness, and timeline.

Xseer can support pre-formulation, formulation development, analytical development, IND-enabling preparation, early- and late-phase clinical supply, process scale-up, process validation, commercial readiness, and product lifecycle support. The development plan and quality framework are structured according to the product’s current phase.

Yes. Xseer provides pre-formulation and formulation-development services designed to establish products that are stable, manufacturable, testable, and scalable. Xseer can also develop, optimize, qualify, transfer, and validate analytical methods based on the product’s development phase and intended regulatory use.

Yes. Xseer provides phase-appropriate Chemistry, Manufacturing, and Controls support to align formulation, analytical methods, manufacturing processes, specifications, stability programs, and quality controls with the product’s development pathway. The product sponsor remains responsible for its regulatory strategy and submissions unless otherwise established in the project agreement.

Xseer evaluates private-label opportunities through its CDMO division. Services may include formulation, manufacturing, analytical testing, filling, packaging, labeling, and supporting documentation. Each project is subject to technical, regulatory, quality, commercial, and intellectual-property review.

Do not use a product that appears damaged, compromised, incorrectly labeled, or inconsistent with the order. Maintain the product and original shipping materials under the required storage conditions and contact Xseer promptly. Provide the order number, product name, lot number, quantity, delivery date, photographs, and a description of the issue.

Contact Xseer and provide the product name, strength, dosage form, lot number, beyond-use date, order information, description of the concern, storage conditions, relevant photographs, and contact information for follow-up. Do not discard the product or packaging unless instructed to do so.

Report the event to Xseer using the company’s official contact information and provide the available product and event details. Serious or urgent medical concerns require immediate evaluation by an appropriate healthcare professional or emergency service. Reporting an event to Xseer does not replace emergency medical care or any reporting obligation applicable to the healthcare provider.