Don’t Disregard Your OOS Rate

As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR).  The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results. 

Compounding Pharmacies Still in FDA’s Crosshairs

From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations.

It is certain that FDA is continuing to apply pressure on this industry with no letup in sight.

Improving Health of the Least of Us for the Benefit of All of Us – A Guest Blog

My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network.  Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends,

Revisions to Compounding Guidance?  Where Will That Take Us?

It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities.  Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities (to date,

FDA Announces Outsourcing Compounders Fees

The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018.

Compounders Outsourcing Fees FY 2018

Establishment

Small Business*

$5,364

Non-Small Business

$17,364

Re-inspection Fee

$16,093

* To qualify revenue must be less than $1,000,000 for all sites and affiliates

The Notice states that “FY 2018 registration period for outsourcing facilities starts on October 1,

PDUFA VI Fee Structure and Fees Announced – Gulp!

In a Federal Register (FR) notice published today (here), the FDA announced that the base amount for the prescription drug user fee (PDUFA) program for new drugs would be $878,590,000, plus another $22,415,658 from something called the “capacity planning adjustment”, which is based on the elements the Agency is using to calculate costs (see list below) ,

How Robust are Your Data Review Procedures?

The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review.

Data review should be based upon a thorough process which is defined within the procedure.

Don’t Guess Any Longer! Read the Guide on Ex-Date for Unit Dose Repackaged Products

For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.  (see full guidance here). 

Pharmacy Compounding in the News Again – Difficult to Compound List – A Long Time Coming

Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA advice about the Agency’s efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act (version in effect in 2000).  

Child-Resistant Packaging – FDA Issues Labeling Guidance

The question of where, when, and how to label a product, whether it be a prescription drug, OTC product under an approved application, or an OTC product marketed under the monograph system has always been kind of a guessing game for manufacturers, packagers, and repackagers.  Now, a new Guidance titled “Child-Resistant Packaging Statements in Drug Product Labeling” answers many of those questions and provides guidance as to how to be in compliance with the FDA regulatory scheme.

User Fee Bills Need to be Paid but Reauthorization of User Fees Needs to be Passed – SOON!

FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures.  Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees. 

Proposed Labeling Rule Shifts to Long Term Action on HHS/FDA Agenda

The controversial rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change” has shifted to long-term actions on the HHS unified agenda (here). 

Public Meeting on Balance of Hatch-Waxman – Some Observations

On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”.  The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”

While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar. 

Is Your Instrumentation Qualified for Intended Use?

The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> are as follows:

  1. The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the instrument.