A Letter to Editor from Cantrell Drug Company

Quality Measures at Compounding Facilities

To the Editor:

Your article on FDA regulation of compounding pharmacy

and outsourcing facilities (“FDA Draft Guidances Compound

the Compounding Uncertainty,” June 2014 [pages 424–426,

435]) did not present readers with a full and complete picture

of quality measures in place at FDA-registered outsourcing

facilities, and instead relied on a series of FDA reports that

in many instances predated the law that created the new outsourcing

facility category.

In the case of Cantrell Drug Company, we never received

an FDA warning letter, as the article asserts. We received

a Form 483, and the period it covered was before the Drug

Quality and Security Act (DQSA) was passed and before we

became an outsourcing facility. Moreover, the author seems

to use “Form 483” and “warning letter” interchangeably, but

they are separate and distinct actions. We provided a detailed

response to the FDA’s Form 483. As the author himself noted,

the FDA generally leaves “open” Form 483s, even when they

have received a thorough response and all observations have

been addressed, which occurred in the instance of Cantrell.

Prior to its registration with the FDA as an outsourcing

facility, Cantrell Drug Company for many years maintained a

valid FDA registration for drug manufacturing/compounding,

an uncommon and deliberate quality assurance decision at the

time. We have had an impeccable record on quality and compliance,

as a result of a rigorous quality assurance program that

adheres to applicable current Good Manufacturing Practices

(cGMP). Through the passage of the DQSA and enhanced

state oversight and regulation, the quality of compounded

medications has never been better, and that is the point that

should have been communicated in P&T.

Dell McCarley, PharmD

Chief Executive Officer

Cantrell Drug Company

Little Rock, Arkansas

Editor’s note: The author of the article, Stephen Barlas, notes

that he attempted via telephone, and in an email exchange

with Dr. McCarley’s assistant, to arrange an interview

to discuss this issue prior to the article’s publication.

However, he did not receive a response. The statement

that the quality of compounded medications has never

been better is open to debate.
quoted from here