(FDA Guidance for Industry) (Excerpts)
November 2020

I. INTRODUCTION

A drug is considered adulterated "if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health..." Drug products prepared, packed, or held under insanitary conditions could become contaminated and cause serious adverse events, including death.

The guidance is issued to help compounding facilities and state regulatory agencies understand what the FDA considers to be "insanitary conditions" and is also intended to help identify and remediate insanitary conditions when they already exist.

II. BACKGROUND

The Guidance reiterates again the example of almost 10 years ago where sterile drugs that were compounded under insanitary conditions (NECC) actually seemed to be outside the scope of appropriate compounding. It also mentions "insanitary conditions" that have been observed at compounding facilities they have inspected and some have resulted in voluntary drug recalls and temporary or permanent ceasing of sterile operations.

FDA routinely inspects 503B Outsourcing Facilities but not state-licensed pharmacies unless they receive a complaint, such as a report of a serious adverse event or product quality issue.

Regardless of whether a facility is routinely inspected by the FDA, both state-licensed pharmacies and outsourcing facilities must prevent the occurrence of insanitary conditions within their facilities. If any are identified, they should be remediated before the conditions result in contamination and patient injury.

Next week, we will look at Part III POLICY (including examples).

III. POLICY

1. Examples of Insanitary Conditions
   1. Insanitary Conditions Applicable to the Production of Sterile and Non-Sterile Drugs
   2. Insanitary Conditions Applicable to the Production of Sterile Drugs Only
      1. Gowning and Aseptic Practices
      2. Equipment/Facilities
      3. Sterilization
      4. Cleaning and Disinfecting
      5. Other Insanitary Conditions
2. Preventative and Corrective Actions for Insanitary Conditions
3. Regulatory Action

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition

"Did You Know" Correction

Many thanks to Pharmacist Carmen Berg, RPh, MOL, BCGP (DSHS/DDA), who corrected us on last weeks "DID YOU KNOW."

"George Eliot" was the pen name for Mary Ann Evans (November 22, 1819 to December 22, 1880), an English novelist, journalist, translator, and one of the leading writers of the Victorian era. She wrote seven novels: Adam Bede, The Mill on the Floss, Silas Marner, Romola, Felix Holt, the Radical, Middlemarch, and Daniel Deronda.

Did You Know...

...the following?

Oath of Office for Members of Congress:

"I do solemnly swear (or affirm) that I will support and defend the Constitution of the United States against all enemies, foreign and domestic; that I will bear true faith and allegiance to the same; that I take this obligation freely, without any mental reservation or purpose of evasion; and that I will well and faithfully discharge the duties of the office on which I am about to enter. So help me God."

Oath of Office for the President of the United States of America:

"I (President elect name) do solemnly swear (or affirm) that I will faithfully execute the Office of President of the United States, and will to the best of my Ability, preserve, protect and defend the Constitution of the United States."

Thought of the Week

Sometimes one wonders if our elected officials really thought about the oaths of office they took or have even read and understand the Constitution of the United States and the Bill of Rights! It just seems that we, the people, are losing our voice in the political system to the media, the rich, and to special interest groups!

Let's not ever forget what former President Gerald Ford said, "A government big enough to give you everything you want is a government big enough to take from you everything you have."