Regulatory Solutions

Confidently navigate a changing landscape with regulatory solutions for 503A and 503B compounding pharmacies.

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Stay Ahead of the Game

Letco’s Regulatory Solutions Program provides peace of mind and expert services that address your compliance needs at industry-leading price points.

Confidently navigate a changing landscape with regulatory solutions for 503A and 503B compounding pharmacies. FDA, DEA, and state board regulations are confusing. Staying compliant requires compounding pharmacies to hit a moving target.

That’s why Letco Medical spent six months working with Sweetgrass GxP to develop a new Regulatory Solutions Program to help pharmacies keep up. We invested countless hours crafting and refining methodologies and deliverables tailored to the needs of compounding pharmacies.

Pharmacies can trust Letco’s Regulatory Solutions Program to provide best-in-class deliverables at a price other compounding suppliers can’t match. And better yet, any Letco customer in good standing can take advantage of this valuable program.

Ask our experts how to get started

Services We Offer

  • USP <795>, <797>, <800> Compliance and Readiness Assessments

Start with an on-site inspection to give you a detailed view of potential compliance and readiness issues.

  • USP <795>, <797>, <800> Customizable SOP Libraries

Get help putting together Standard Operating Procedures to help you stay compliant.

  • Staff Training Programs Tailored for Each Pharmacy

Keep your staff trained and up to date, and make sure they understand their obligations.

  • 503B Outsourcing Compliance and Quality Assurance

Ensure your partners are treating regulatory compliance as seriously as you are.

  • Mitigation and Remediation Services (FDA, DEA, State Boards, etc.)

Address regulatory issues proactively and effectively.

Getting Started

Letco customers may contact us to discuss your pharmacy’s regulatory needs and review the services we have available to address your specific situation.

A Sweetgrass GxP representative will then contact you within two business days with a proposed scope of work. Typically, you can schedule a site visit within two to four weeks of executing a Statement of Work.

Get started by talking to our Compounding Support team

We Are Letco. Let Us Help.

I love being in the compounding business, one that provides quality care and amazing health outcomes for my patients. It is my belief success will come to those compounders maintaining regulatory compliance while preserving a high level of patient care. To that end, Letco’s Regulatory Solutions Program provided a very valuable service that I expect will save me $20,000 or more. I would heartily recommend the program to any compounding pharmacist serious about future success in this industry.

Jim Hrncir RP Owner, Las Colinas Pharmacy, Compounding and Wellness

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