This week we will look at the first of two 503A Guidances: "Pharmacy Compounding of Human Drug Products Under Section 503A of the FFDC Act". You are strongly encouraged to obtain a copy of this Guidance which can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM469119.pdf .

1. Introduction
   This section provides general information related to the purpose of the Guidance.
   
   
2. Background
   A short historical review and update on compounding leading up to the DQSA of 2013.
   
   
3. Policy
   The FDA expects state boards of pharmacy to continue their oversight and regulation of the practice of pharmacy, including pharmacy compounding. It will continue to cooperate with state authorities to address pharmacy activities that may violate the FD&C Act.
   
   
   1. Conditions of Section 503A
      This section describes the requirements for exemption for compounded drugs.
      
      
   2. Provisions of Section 503A That Require Regulations or Other FDA Actions
      This section lists the rulemaking activities the FDA and the Pharmacy Compounding Advisory Committee are currently working on.
   
   
   
4. Guidance on Regulatory Action
   1. Requirements Applicable to Drug Products That Meet the Conditions of Section 503A
      This section lists 5 violations (but it is not limited to these) that may result in a warning letter, seizure of product, injunction, and/or criminal prosecution for violations of other requirements of the FDS&C Act.
      
      
   2. Enforcement Action When a Drug Does Not Meet the Conditions of Section 503A
      This section lists violations (but it is not limited to these) that may result in a warning letter, seizure of product, injunction, and/or criminal prosecution for violations of other requirements of the FDS&C Act. Examples include:
      • Producing adulterated drugs
      • Producing unapproved new drugs
      • Misbranded drugs
      
      
      
   3. Enforcement Approach
      Generally, the FDA employs a risk-based enforcement approach giving the highest priority to violations that pose the greatest public health risks. However, the FDA emphasizes that it need not identify a particular safety problem before pursuing enforcement action.

Next week, we will look at the second of the two 503A Guidances; this one involving using bulk drug substances in compounding.

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

News

KCl Price May Increase$$$ Here we go again!
Generic drugmaker Virtus Pharmaceuticals recently petitioned the FDA to hold up on its plan to remove unapproved generic versions of potassium chloride from the market and has now filed a lawsuit demanding the FDA put on the brakes. Virtus alleges that if the FDA follows through, it will hand a monopoly on the generic drug to a couple of companies that is sure to lead to much higher prices for a treatment that has been sold for nearly 70 years and grandfathered in as a safe generic. The suit requests a declaratory judgment that FDA may not take enforcement action against Virtus' product without a formal and specific determination that the product is either unsafe or ineffective.
http://www.fiercepharma.com/pharma/virtus-sues-fda-says-agency-move-will-lead-to-potassium-chloride-price-hikes

It's OK to Use Oral Liquid Docusate Sodium Not Made by PharmaTech
The FDA investigation related to the oral liquid docusate sodium has identified the bacteria, Burkholderia cepacia in more than 10 lots manufactured by PharmaTech, Davie, Florida. The investigation found B. cepacia in the water system used to manufacture the product. These products were manufactured by PharmaTech and distributed and labeled by six firms - Rugby, Major, Bayshore, Metron, Centurion, and Virtus. Also, FDA's current laboratory results do not indicate that it is the active pharmaceutical ingredient used to manufacture oral liquid docusate is the source of the B. cepacia outbreak.
http://www.fda.gov/Drugs/DrugSafety/ucm511527.htm

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Did You Know ...

�sometimes I wonder just how smart we really are today; or, is it that we just have instant access to information and technology.

Tip of the Week

I have heard it said that we are smarter (some say more intelligent) today than our ancestors were. Just looking around at our society and cultures worldwide, I'm not so sure about that. True we can send a man to the moon but we don't know how the Great Pyramid was built; we can treat a lot of diseases but we still don't know exactly what happens at the instant of death. We decided Pluto was no longer a planet and just last week were told that our universe is ten times larger than previously thought!

The definition of "smart" in a dictionary is "characterized by sharp, quick thought; intelligent, bright". I am sitting here just wondering how much "quick thought" is required to do a "google search", watch television, play video games, or text/email a friend? Sometimes it seems like we just want to think we are smarter because we have great technology to use.

Looking Back

Many a forest,
Used to stand,
Where a lighted match,
Got out of hand!
     Burma Shave