ISPE “Drug Shortages Assessment and Prevention Tool” is Launched Today

Today, at the ISPE Annual Meeting in Philadelphia, an important new tool in the battle against drug shortages will debut. The “Drug Shortages Assessment and Prevention Tool” drew on feedback from ISPE 2013 Drug Shortages Survey and 2014 Drug Shortages Prevention Plan, and focuses on the prevention and practical application to help industry assess its preparedness for mitigating drug shortages.

Sit! – Stay! – No IND Needed as Part of Guidance Document is Stayed

Last Friday, FDA published a Notice in the Federal Register (here) relative to staying a portion of its September 2013 Guidance Document titled Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND.  The Agency indicated that, based on comment received on various sections of the final Guidance,

How Deep is FDA Diving in GMP Compliance for Compounding Pharmacies? Just Watch the Recalls and Warning Letters!

With Warning Letters (WLs) and significant FDA 483 observations continuing to confront the compounding pharmacy space, FDA is entering into rounds two and three of inspections to determine if corrective actions have been adequately and timely completed and if the compounding pharmacies understand compliance in this space

To Compound or Not to Compound? That is the Question!

To Compound or Not to Compound? That is the Question!

FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use in the compounding of drug products and has described its interim enforcement policy regarding drugs compounded under Section 505 A (dealing with pharmacy compounding) and Section 503 B (dealing with outsourcing facilities) of the Federal Food Drug and Cosmetic Act.

Single Patient Use – A New Label Term for Parenteral Products

FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. This draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms

FDA to Publish ALL Comments Submitted by Individuals to Dockets on

Well, as someone who routinely reviews postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through.  Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to,

FDA Is Diving Deeper in GMP Compliance for Compounding Pharmacies – A Follow-up

FDA Is Diving Deeper in GMP Compliance for Compounding Pharmacies – A Follow-up

Warning Letters and significant FDA 483 observations continue to confront the compounding pharmacy space. (See previous post here: With over 40% of compounders inspected receiving Warning Letters and nearly 100% receiving critical observations, can this industry respond effectively and meet FDA expectations?

Up the Ladder – Dispute Resolution Draft Guidance Gets 2nd Revision

Today, the FDA released its second revision to its “Guidance for Industry – Formal Dispute Resolution: Appeals Above the Division Level”. The revised draft Guidance expands the previous Guidance (released in March 2013) to include applications covered under the Biosimilars User Fee Act of 2012 (BsUFA) and provides additional clarification as to what matters are not appropriate for Formal Dispute Resolution Requests (FDRRs).

Second Potassium Chloride Oral Solution Approved by FDA – Will Enforcement Action follow?

On August 19, 2015, the FDA approved a second 505(b)(2) drug application for potassium chloride oral solution, a potassium replacement therapy typically for patients taking potassium-depleting diuretics. Previous to this approval, FDA approved another 505(b)(2) application for the drug on December 22, 2014.

Prior to that date, there were a number of marketed unapproved prescription drug products for potassium chloride oral solution on the market as “grandfathered” drugs or “DESI similar and related” drugs. The market for potassium replacement therapy is rather large and, while there are numerous approved solid oral dosage forms available in the marketplace, many patients cannot take those products for various reasons. Only time will tell, but one might think that this second potassium chloride oral solution approval may signal another enforcement action in the near future.

Draft Biosimilar Naming Guidance Hits the Street

FDA released its long awaited Guidance on naming of Biosimilar products (Nonproprietary Naming of Biological Products – Guidance for Industry) today. In what is not too much of a surprise, especially after the first approved biosimilars name had a suffix (Zarxio, filigrastim-sndz), the FDA opted for most biosimilar products to have a suffix. In addition, FDA is proposing to assign a suffix to the originator biologic products.

FDA Clarifies Issues Regarding Outsourcing Pharmacies

The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.”  Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food,

Compounding Pharmacies – Is Anyone in Compliance???

Imagine an industry where approximately 40% of firms inspected receive Warning Letters and nearly 100% receive substantial FDA Form 483 observations. Publically available information indicates that the FDA has issued 19 Warning Letters to compounding Pharmacies just in 2015 and 41 and counting to date in the last two and a half years.  There have been numerous recalls due to lack of sterility assurance,