Frequently Asked Questions About Pharmaceutical Compounding

What is compounding, and why is it necessary?

Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued. The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

By Michael Sadick, Ph.D. and Dan Papa, Catalent Biologics

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

Get insights on how Octet-based Fc Receptor Panel test allows for rapidly adaptable assessment of monoclonal antibody therapeutics

Our mobile compounding center featured in the February issue of Pharmacy Purchasing & Products Magazine

Our mobile compounding center was featured in the latest issue of the PP&P Magazine who showcased our plug and play mobile cleanroom as this months’ new and noteworthy addition to the industry.

FDA’s Gottlieb outlines new goals in budget plan, looking to spur drug reviews

President Donald Trump’s budget sought a boost in funding for the FDA and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plans to pursue.

Plans outlined by Gottlieb include the creation of two new centers related to drug compounding and digital health.

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

For Immediate Release

January 29, 2018



Recall Department



Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

An Analysis Of FDA FY2017 Drug GMP Warning Letters

By Barbara Unger, Unger Consulting Inc.

FDA Provides Some Guidance for 503B Facilities


On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.

Compounding pharmacy increasingly popular during flu season


Compounding pharmacy has become increasingly popular across Central Florida since the uptick in flu cases.

Eyewitness News reported last week that there is a shortage of the generic version of Tamiflu and the price of brand-name of Tamiflu has skyrocketed.

FDA Releases Compounding Priorities Plan

The U.S. Food and Drug Administration on Jan. 24 issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement key aspects of the Drug Quality and Security Act and other provisions of the law relevant to compounders.

Top Organizations Urge a Concerted Effort To Improve Safety in Hospital Compounding

Five years after the New England Compounding Center (NECC) tragedy that brought to light safety problems stemming from the compounding of pharmaceuticals and other therapies, a white paper was released today reflecting the recommendations of major stakeholders for additional steps needed to improve patient safety relative to compounded medicines.  The paper was the outcropping of a milestone dialogue where top pharmacy, healthcare provider, hospital and patient organizations assessed progress made since the 2012 NECC tragedy and the subsequent enactment of the Drug Quality and Security Act by Congress.