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Licensure

We hold pharmacy license # P06672 with the State of Maryland Board of Pharmacy. Currently the State of Maryland does not (yet) issue a license specific to compounded sterile preparations (“CSPs”).

The Board of Pharmacy is currently scheduled to begin the licensing of pharmacies preparing CSPs beginning July 1, 2015. We actively support the implementation of a specific sterile compounding license for all facilities performing sterile compounding within the State of Maryland and will be one of the first to apply for a sterile compounding license.

You can find more information about this issue on the Maryland Board of Pharmacy website at http://dhmh.maryland.gov/pharmacy/sitepages/home.aspx

All sterile compounding technicians hold a specific pharmacy license with the Maryland Board of Pharmacy. In addition, among other tests, we require each technician to pass several sterile compounding media fill challenge tests prior to compounding and every six months thereafter as part of our Quality Management System’s compliance to USP and .
We are focused on serving the needs of patients in the State of Maryland. As such, we provide a very high level of consultative and logistical service to physicians, their staff, and patients.

Environmental Monitoring

Yes. We perform weekly environmental surface monitoring of all sterile compounding areas. In addition, we perform viable air particle environmental monitoring monthly and non-viable air particle testing every six months. We also routinely perform glove tip testing on our sterile compounding technicians.
We have standard operating procedures (“SOPs”) that define the frequency and standards of daily, weekly, and monthly facility maintenance and cleaning. All maintenance and cleaning activities are recorded on logs of use, maintenance, and cleaning (“LUMACs”). In addition, we monitor the temperature, humidity, and pressure of each compounding chamber and room.
Several indicators of quality problems are in place, including air pressure, temperature, and humidity monitoring, air and surface environmental sampling, and product sterility testing.

Personnel

All steps are reviewed and verified by a compounding pharmacist with particular attention on:

  • Pre-compounding formulation review
  • Pre-compounding ingredient review
  • Technician qualification
  • Final compound quality assurance
Per USP regulations and our Quality Management System, all sterile compounding technicians must pass a rigorous series of compounding tests every 6 months.

Product Integrity

Yes, our Quality Management System defines the scope and scale of our equipment and facilities cleaning, maintenance, and calibration protocols. All critical equipment is independently re-certified every six months.
Per USP 797 we perform routine testing on finished preparations including tests of potency, sterility, and endotoxin content among other tests. We contract the testing to an independent third party laboratory that specializes in testing of compounded sterile preparations.
All finished preparation storage areas, including refrigerators and freezers, are monitored for temperature and humidity. Preparations that are subject to light degradation are packaged in amber containers and/or amber over packaging.
Yes, we do routinely perfume sterilization via filters with pore sizes 22 micron and less. We perform bubble point filter testing on every filter to ensure the integrity of each filter.

Quality Management System Documentation

We utilize a compounding-specific software program to trace our raw materials, formulations, technicians, expiration dates, labeling, and patient specific information among other things. This software system has robust security and the data is constantly backed up at a secure server off site.
We retain these electronic records indefinitely.
Yes. Our Quality Management System has SOPs defining the process of developing a formulation, selecting raw materials, quality control, sterility, stability, strength, and beyond use dating.
Yes. He has over 15 years of FDA-regulated manufacturing experience in GMP and GTP environments. He also co owns the company with our Pharmacist-in-Charge.
The fully Quality Management System is reviewed from top to bottom at least annually. Individual SOPs are reviewed and modified on an as-needed basis routinely.

Quality Assurance

Yes. All customer complaints are investigated until a root cause is determined. The root cause is reviewed internally and often we initiate a corrective and preventative action (CAPA). The CAPA might result from analyzing processes, customer complaints, and audit reports among other things.

The CAPA program involves:

  • Identifying problems that may require corrective action;
  • Deciding if corrective action is required;
  • Correcting the problem;
  • Investigating and determining the root cause(s) of the problem and proposing appropriate corrective action if necessary;
  • Implementing the corrective action to eliminate the root cause(s);
  • Verifying that the corrective action is implemented and that it is effective.
Yes. We operate as if the FDA will audit us at any time without notice.
Absolutely, we encourage it! In fact, we have a self-audit checklist you can use to guide you through the audit. Call us to schedule your audit anytime.