Proposed Rule Issued Based on Tentative Final Monograph for Waterless Hand Rubs for Consumers

The Proposed Rule based on the Tentative Final Monograph (TFM) (here) is a 101-page monster that addresses consumer-type hand rubs that are designed to be used without water – generally, what one might think of as “hand sanitizers” (or “consumer antiseptic rubs” as the FDA terms them).  The Proposed Rule DOES NOT cover “OTC consumer antiseptic washes and OTC antiseptics intended for use by health care professionals in a hospital setting or other health care situation outside the hospital are GRAS/GRAE.”

In the document,

What’s the Delay, FDA?

As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection.  At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law or regulations. 

Important Note: There Are Two Different Everolimus Bioequivalence Guidance Recommendations – Be Careful Which You Rely Upon

In the most recent update of the bioequivalence (BE) recommendations, there is a new Guidance for the conduct of BE studies for Everolimus dated June 2016.  This specific Guidance covers the use of the drug in treating organ rejection (here).  A previous Guidance document (initially issued in March 2011 and then revised in June 2012) covers a different product where the indication is for oncology (here).

No Fast Dissolving Dosage Form for Cats Without Studies


FDA has denied an interesting petition that requested a change in dosage form from a solid oral tablet of methimazole to a rapidly disintegrating tablet for cats.  The Agency said in its denial letter:

“Your proposed change from the RLNAD with the justification you cited from Hatch-Waxman Amendments, 1984, does not support the change you proposed for your generic drug product because the safety and effectiveness of a disintegrated dosage form has not been established in cats.

Technical Reference Document Issued for Quality Metrics

The FDA today released a technical reference document entitled, “Quality Metrics Technical Conformance Guide for the Implementation of the Draft FDA Guidance for Industry on Requests for Quality Metrics.”

This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported.  Remember that,

Four New Paragraph IV Listings Reported

OGD published an updated version of its Paragraph IV database (here)This database lists those products that are both first-to-file and have made a paragraph IV certification claiming that at least one patent on the reference listed drug (RLD) upon which its ANDA is based will not be infringed, or that the patent is invalid or unenforceable relative to the product subject of its ANDA filing.  

Here Is Something to Chew On

Ever had a tablet that was too big and you wished you could chew it?  Well, some immediate-release tablets are designed to be chewable and carry such designation.  The Guidance, titled “Quality Attribute Considerations for Chewable Tablets” (here), addresses the desired features of chewable tablets and describes the attributes that FDA evaluates when developing such products either in an NDA or ANDA.

New BE Requirements for Propofol Injection

Today, the FDA issued 19 new and 19 revised bioequivalence (BE) recommendations for the conduct studies of products subject to abbreviated new drug applications (ANDAs).  One of the new recommendation relative to propofol injection caught my eye.

The issue of interest concerns the newly stated requirement for quantitative (Q1) and qualitative (Q2) sameness of the formulation of product beyond what has been required in the past. 

Compounding Guidance Finalized by FDA

With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action.  This also obviously assumes that the facility is operating in accordance with the appropriate controls by state or federal agencies.

Ricki A. Chase, New Director, Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Ricki A. Chase will join Lachman Consultants as a Director in the Compliance Practice, effective June 20, 2016.

Ricki Chase comes to Lachman Consultants after an impressive 16-year career, culminating as Director, Investigations Branch at the U.S. Food and Drug Administration where she was responsible for all operations of the Investigations Branch,

May 2016 ANDA Approval and Receipt Data Released

Just two days after our Tentative Approvals and Receipts post (here), the Office of Generic Drugs (OGD) partially updated its Activities Report of the Generic Drug Program 2016 to include May approval statistics and new ANDA receipts.

OGD approved 54 ANDAs and Tentatively Approved 20 ANDAs. (The FDA Monthly approval site still has listed only 47 approvals and 16 TAs a discrepancy of 13% and 20% respectively). 

May Monthly ANDA Approval Information – But the Wait is On!

Information on the FDA’s Monthly Approval Report (here)  is usually not complete.  Typically, there may be up to a 5-10% discrepancy (lower than actual) in the numbers of Approvals and Tentative Approvals reported.  The discrepancy improves over time but seldom do the numbers actually match the reported number of approval actions on the Activities Report of the Generic Drug Program for the same month.