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Clinical Presentations & Public Speaking

As a leader in CSP compounding and medication safety, LDT can develop and present on a myriad of clinical and operational topics. These areas include but are not limited to:

  • Regulatory and other statutory compliance strategies, including the Drug Quality and Security Act (DQSA)
  • FDA activity in and around compounding pharmacies, prescribers & institutional providers (including physicians, clinics, hospitals & health systems)
  • Automated Compounding Devices, Technologies & Techniques
  • Compounding Under USP <795> & <797> & <800>
  • FDA registered Outsourcing Compounding (503B) for your healthcare organization
  • Medication Safety & Quality Improvement topics
  • Medication Quality Management & Policy Development
  • Improving workflow, operational efficiencies, & policy compliance in the compounding areas & cleanrooms
  • Procurement strategies to assist in drug shortage situations
  • Formulary management to efficiently procure CSPs from FDA Registered Outsourcers
  • Hazardous Drug compounding & Regulatory compliance - <USP 800> (OSHA & NIOSH topics)
  • Evaluation of drug stability data & determinations of BUD of CSP formulations
  • Personnel training programs for cleanroom operations (Sterile or Non-sterile)
  • Cleanroom design & building basics (including Segregated Compounding Areas)

LDT can develop and present these topics live, by webinar, or as part of your organization’s staff development efforts.

Lou and Dave

ProCE™ - The STERILE COMPOUNDING CERTIFICATE PROGRAM

LDT is proud to have partnered with ProCE™ a trusted national provider of quality medical education to bring you The Sterile Compounding Certificate Program is an online course for pharmacists and pharmacy technicians interested in developing and demonstrating expertise in sterile compounding. The program utilizes self-study modules to gain expert understanding of compounding standards and regulations, and a practical component in a virtual cleanroom environment where users will learn and practice sterile compounding skills and technique.

This comprehensive program covering both sterile and non-sterile compounding is accredited by ACPE® for Pharmacists. Additionally, this educational activity has been approved by PTCB® as a training program for technicians pursuing the Certified Compounded Sterile Preparation Technician (CSPT) recognition.

Please visit ProCE Learner Community for specific details.

Please visit Penguin Innovations for more information on the virtual cleanroom.

Specialized Services

All drug compounding whether sterile or non-sterile does not occur in Pharmacies alone. Prescribers, and other specialized healthcare practices routinely provide medications to their patients. LDT lends it expertise and experience to enhance the quality of these care models and can increase the level of regulatory compliance in these focused healthcare settings.

These practices include:

  • Physician Offices (e.g., Oncology, Ophthalmology, Infertility, & General Wellness)
  • Ambulatory Infusion Suites, Walk-in-Clinics & “Urgi-Centers” (Healthcare System or Stand-alone models)
  • Veterinary Practices

The regulatory landscape beyond the local Board of Pharmacy’s jurisdiction for the compounding of medications in any of these practice settings is just as complex, and requires special consideration when auditing, evaluating, and critiquing their service models. Universally these practices need to negotiate the overlapping jurisdictions and demands of the following agencies: OSHA / NIOSH, the US Department of Labor, CMS, FDA, DEA, local medical boards, local departments of health.

Use of the improper point-of-view when evaluating these specialized practices for medication handling and compounding compliance can cause many downstream problems. Most commonly manifested as overspending on remodeling or over building of facility engineering, improper development of policy or processes, improper or incorrect staff orientation & training, and delays in implementation because of errant applications. These along with many other unintended consequences can result from the improper selection of a regulatory consultant.

LDT can develop practical, no nonsense approaches that balance your service model requirements with an eye to full regulatory compliance. Please contact us to discuss your unique concerns.

Compounding Expertise

Whether your business depends upon sterile or non-sterile compounding or both, LDT’s pharmacists and certified technicians have a wealth of clinical and technical expertise in both cGMP and compounding (503A or 503b models) for both sterile and non-sterile preparations. The delivery of compounded preparations (both sterile & non-sterile) in the current health care delivery model requires both technical resources and solid employee training to prepare and deliver these medications safely. At LDT our team has over 40 years of compounding, outsourcing, and formulation experience to assist you.


Cleam Room Image

We can analyze your processes for regulatory and practice gaps, compare your current processes against demonstrated best practices. We can develop action plans for correction of these gaps or analyze your operation for improvements or efficiencies to make your overall program better. Our experts develop solutions that center upon the “controlled process” concept of using “best-in-class” equipment and practices, in a defined and controlled way, consistently each and every time, and to document this process universally to satisfy any regulatory and oversight body.


Clean Room Image

LDT has developed compounding methodologies and accompanying documents for all types of medication preparations no matter how complex. These include, custom Cardioplegia, complex Dialysate solutions (CVVH & CRRT), Total Parenteral Solutions (TPN), small volume preparations (SVPs) and large volume parenterals (LVPs). Let us assist you in developing a consistent, solid library of master compounding documents to standardize operations, reduce the possibility of errors, and raise your level of quality in the compounding and mixing process.



Facility Design

Cleanroom Design Image

LDT can assist you in the establishment, expansion, or re-model of your current compounding space, or in a total redesign of your entire compounding & clean room complex (including segregated compounding areas). No project is too large or small; each complex is designed with your organization’s specific needs and demands in mind. All our projects use the “Pharmacist’s Eye” to confirm proper workflow and efficient movement of product both in and out of the rooms and minimization of staff unproductive activities. We specialize in design with careful attention to federal standards (CMS, OSHA, FDA) local regulation (BOP, DOH), and USP <795>, <797>, and <800> considerations.



Cleanroom Airflow Design Image

We can work with your organization’s contractors, architects, and builders to smoothly and efficiently get your complex build, validated, certified, and running. We also specialize in transition planning to assure that your critical functions are uninterrupted during any remodeling or construction. LDT has over ten years of experience in soft wall, hard wall, modular, and mobile clean room applications, please contact us for a consultation.



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.

FDA Compounding Compliance Database

While compounding of medications was always part of Federal oversight authority, no matter who is conducting this medication compounding (physicians, pharmacists, or technicians) since the New England Compounding Center (NECC) disaster all Federal agencies and in particular, FDA has stepped up their oversight efforts in any and all establishments that compound medications. Pharmacies (both 503A & 503B), Physician’s offices, Analytical Laboratories, Homecare providers, Ambulatory Infusion Centers, as well as Hospitals & Health Systems have been regularly and intensively visited by the agency.

Generally speaking, compounders (and the attorneys who may represent them) have little or no experience in dealing with this type of Federal scrutiny. Furthermore, even the few experienced compounders and counselors can benefit from the global gaze that a larger pool of information can provide. LDT collects vital FDA data from the agency and the public domain daily to build our proprietary database and has done so since December of 2012.

LDT codifies every observation from every available FDA form 483, tracks each establishment visited, and each inspector who creates these inspectionary documents. LDT regularly analyzes this data to drive our knowledge base. This information can be seen in Policy & Procedure updates, changes to our training materials, and in the evolution of our client advice.

LDT provides this vital data as a regular monthly subscription service to your compounding or legal practice to help you understand what the current landscape looks like, and how it changes over time. LDT can also provide custom reports tailored to your practice area (503A vs. 503B), tracings of individual FDA field offices, or individual inspection personnel. Having this additional data can assist you as the inspection is progressing, it can help predict document or information requests, and certainly will make the creation of your formal time-sensitive written response easier.

Contact us for more details regarding this powerful service.



Compounding & Gap Analysis
LDT can lend its experience and expertise to access your organization’s compliance and regulatory readiness.
Knowing where your program’s weaknesses are, can be the first step in developing an action plan to address your developmental needs.

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Time & Motion Studies
LDT can assist in identifying areas for
improvement and suggest creative and
proven methods to maximize your staff’s
capabilities.

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Policy & Procedures
LDT can assist in this on-going activity by analyzing
your P&P collection to look for procedural gaps,
regulatory inconsistencies, and to assure that your
organization is operating using the latest best
demonstrated practices to strive for peak efficiency.

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Controlled Processes
Through the process of reviewing your organization’s activities
and focusing on the possible points of "critical failure" LDT can
develop systems which may minimize or eliminate these
"failure points" and enhance the overall quality of your products
or services.

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Action Planning
Once an organization has taken stock and identified key areas
for improvement or gaps in current practice, the task of
developing a "road-map" to get there is sometimes daunting.

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Plans Of Correction
LDT has a broad experience in the
formulation of custom POCs to address
State Board, FDA form 483 deficiencies,
and responses to FDA Waring Letters
and other agency correspondence.

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