Outsourcing & Contract Compounding
The provision of contracted compounding pharmacy services from off-site providers is a growing model in healthcare. Beginning in the early 1990’s hospitals have moved high volume, fixed formulations to contract compounders (outsourcing providers) rather than compound these preparations themselves. Since this model carries with it the same responsibilities and liabilities as if you compounded these preparations yourself, LDT can assist at several junctures in this critical service paradigm.
Since November of 2013 with the enactment of the Federal Drug Quality & Security Act (DQSA) the Congress has established Outsourcing Facilities under Section 503B of the Food Drug & Cosmetics Act. These 503B providers are expanding the areas where compounded sterile preparations (CSPs) can reach the patients who need them. Compounding these CSPs for “office use,” and institutional prescribing is an expanding marketplace.
With our experience in planning, design, construction supervision, and by developing and overseeing successful multi-state compounding facilities under both Board of Pharmacy and cGMP regulation, LDT can guide you through the selection process if your organization, health system, or health network is contemplating such a shift in your medication delivery model.
Our services include:
- Development of your provider selection criteria
- Conformation of your project’s feasibility through the use of LDT’s own r-ROI™ (“realistic-ROI cost modeling”) for your project’s budgeting.
- Formulation of your RFP for your perspective provider(s)
- On-Site Compliance Visits (both initial and on-going)
- On-going QA Visits and Audits
LDT can develop as part of your overall 503B outsourcing strategy, a comprehensive plan to accommodate the remaining compounding demands of your organization once you have moved your fixed formulations off-site. This type of strategy can reduce your organization’s overall expense in complying with Federal, State, and Local regulatory burdens, while still maintaining your organization’s ability to custom compound on site.
This comprehensive strategy includes:
- Clean Room Design & Construction Expertise
- Policy & Procedure Review and Development
- Staff Training and Qualification
- On-Going QA Visits and Audits
Finally, if you are part of a larger organization or perhaps have excess capacity in your current compounding suite, LDT has unique technologies and procedures to aid you in “in-sourcing” to meet your organization’s unique compounded medication needs. By centralizing (Central-Fill) your compounding your organization may benefit from reduced overhead costs, better quality control, and total autonomy over your processes. This would include the review of available software & automation to assist you in maximizing your “in-sourcing” (Central Fill) capacity. LDT has several business models for “In sourcing” that may apply inside or outside your organization. Please contact us for more specific information regarding these unique opportunities.