Labs that test safety of custom-made drugs fall under scrutiny

[Nelson Vergel]

The five laboratories conduct testing for about 90 percent of the nation’s large-scale specialty pharmacies, which mass-produce custom-mixed drugs and other medical solutions for doctors, clinics and hospitals.


http://www.washingtonpost.com/politics/labs-that-test-safety-of-custom-made-drugs-fall-under-scrutiny/2013/10/05/18170a9e-255f-11e3-b3e9-d97fb087acd6_story.html

 

[EmpowerPharmacy]

ARL's 483 Report that the FDA issued can be viewed here: http://www.fda.gov/downloads/AboutF...cy/ORA/ORAElectronicReadingRoom/UCM369333.pdf

The main problem that these 3rd party labs were cited for was not requiring their clients to submit proper sized batches for proper USP <71> sterility testing. Here are USP <71>'s standards for sterility testing:

STERILITY TESTING
Use the following guidelines to determine the number of quantity and articles to be tested for each medium.
i) For less than 1mL per container, test the entire contents of the container.
ii) For 1-40mL per container, test half contents of each container (but not less than 1mL).
iii) For >40mL to <100mL containers, test 20mL.
iv) For >100mL containers, test 10% of the contents of the container, but not less than 20mL
v) For &#8804;100 containers, test 10% or 4 containers, whichever is the greater.
vi) For >100 to &#8804;500 containers, test 10 containers.
vii) For >500 containers, test 2% or 20 containers, whichever is less.

As you can see from the above standard the larger the batch, the more of your batch you have to test. This is done to not only test the sterility of the batch, but the sterility of the filling process. Since these testing labs were just requiring their clients to test a single vial and label it as "USP <71> compliant" they were indeed not following standards that they should have been in order to be USP compliant.

This is why it is important for any compounding pharmacy to have an in-house sterility testing program as well as a 3rd-party testing facility to verify each other's processes and results. We have a great section of our website that goes over the quality control methods used in sterile compounding.