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USP <61> and USP <62> Microbial Tests for...

USP <795> states compounders are responsible for ensuring compounded drug products are of acceptable strength, quality, and purity. The chapter also directs compounders to USP <1163> for recommended quality control procedures.

USP <1163> specifies the appropriate microbiological tests of non-sterile products:

  • USP <61> Microbial Enumeration Tests

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Drug Shortages

FDA has identified the following list of drugs for the purpose of the temporary enforcement policies described in 503B guidance and 503A guidance during the COVID-19 public health emergency. 

503B guidance establishes revised cGMP standards and allows outsourcing facilities to compound and distribute drugs needed to treat COVID-19 patients that hospitals cannot obtain from an FDA drug manufacturer due to drug shortage. 

503A guidance allows pharmacies to compound drugs and distribute to pharmacies that are unable to obtain an FDA approved version of the drug or one compounded by a 503B outsourcing facility. 

FDA recommends that State-licensed pharmacies consult with State authorities regarding local requirements.

COVID-19 Industry News and Resources

  • FDA and USP
  • Pharmacy Associations
  • Pharmacy Suppliers

Importance of Sample Amounts...

This article outlines the importance of sample amounts submitted for potency testing and the impact it can have on potency results. Formulations require different sample amounts to allow for an accurate result representative of the compounded preparation. The table below can also be found in ARL's Sample Submission Guidelines

USP <51> Antimicrobial Effectiveness Testing

Antimicrobial Preservatives are excipients added to multi-dose containers for both sterile and nonsterile drug products. These preservatives are used to prevent growth of microbial contamination occurring during the use period. It's important to note that antimicrobial preservatives are not a substitute for good manufacturing practices. 

The USP <51> Antimicrobial Effectiveness Test is a challenge test for aqueous-based products. This test demonstrates the effectiveness of antimicrobial preservatives in preventing proliferation or limiting microbial contamination. It is performed on injections, topicals, oral products, and antacids packaged in multiple-dose containers. Click here to access a table of Common Pharmaceutical Preservatives.

An Update regarding COVID-19

ARL Bio Pharma is prepared and has taken steps to ensure our lab continues to provide testing services during this unprecedented time in the United States. We are taking every precaution to follow CDC guidelines and state and federal mandates regarding COVID-19.

Our laboratory is committed to our responsibility as a business partner in the drug supply chain to keep our clients up and running during this health crisis. To deliver the best technical service, we are available to support you Monday through Friday 7:30 a.m. to 6:00 p.m. CST at 800-393-1595 or 405-271-1144.

ARL is dedicated to assuring the health and safety of our employees, our customers, and the communities we serve. Our laboratory is working with our department and logistic partners to ensure supplies capacity in and out of our laboratory and are continuing to fulfill testing services. We will keep you informed of any impact on our ability to meet turnaround times and expectations.

Please follow the CDC website for the latest updates on COVID-19; and, ARL's website and online portal for service updates.

Thank you for your business and continued confidence in ARL to support your needs.

ARL Bio Pharma

Growth Media Differences

There are dozens of different types of microbial growth media available to Microbiologists, developed for a wide variety of purposes.  The USP references many of these to demonstrate the quality of both compounded drug products and the control of compounding environments.  The various types of media serve specific purposes based on the goal of the test.  This might include recovery of the broadest range possible of organisms in a sterility test, screening for a specific organism if it would be particularly dangerous in a certain dosage form, or capturing anything that might be in the compounding environment that might find its way into finished product.  Microbial growth media can be prepared in both liquid and solid forms, depending on the application.  Tryptic Soy Agar (TSA) and Tryptic Soy Broth (TSB), for example, have the same nutrient profile and similar ingredients, but TSA is a solid and TSB is a liquid.  For conducting passive air sampling, for example, a solid TSA plate is easier to handle and leave out in the hood during compounding.  Liquid media, like TSB, is generally better at growing organisms, and should be used where possible for recovery of microorganism in drug products.  Liquid media is more conducive to growth, since nutrients, oxygen, and waste products move around more freely, and temperature is more uniform and constant in a fluid.

Rapid Sterility Testing

Rapid sterility testing is an alternative test method to USP Chapter <71>, which allows for shortened incubation times compared to the traditional sterility testing method. Where USP <71> requires between 14 and 18 days of incubation before a final test result, a rapid sterility test result can be generated after only 6 days of incubation. A reduction in test time of between 8 and 12 days offers a significant benefit when considering supply chain issues, product release schedules, and the timeliness of contamination investigations. The shortened incubation time is made possible by utilizing advanced technology designed to detect microbial growth much more quickly than visualized by the human eye.

USP <800> Why should you test?

As a compounder, protecting yourself and your staff from exposure to hazardous drugs should be important both from a safety and monetary perspective.  USP <800> applies to sterile and non-sterile compounding pharmacies and anywhere that hazardous drugs are received, stored, or administered.   It is also designed to prevent compounders from incurring fines from OSHA (Occupational Safety and Health Administration) for not providing a safe workspace and not complying with the information in USP <800> or on the NIOSH list.  Compliance with regulations includes having: a negative pressure lab to compound hazardous drugs, the appropriate design, layout, or equipment in the pharmacy to compound these materials, and appropriate controls for handling finished dosage forms.  If a facility is compounding or handling hazardous drugs in a state not enforcing USP <800> but is shipping to a state that is, they must comply.  Even if a state board of pharmacy has chosen not to adopt USP <800>, OSHA is still the regulating agency and can inspect a facility that handles or compounds hazardous drugs and levy a fine if they do not comply.

Open vs Closed Membrane Filtration...

According to USP <71> Sterility Tests, membrane filtration is the sterility test method of choice for filterable pharmaceutical products. Membrane filtration refers to either an open membrane filtration (OMF) or closed membrane filtration system. Not all sterility test systems are the same. It is important pharmacists know the differences between the two systems to reduce the risk of false positive results, costly investigations, and batch loss.