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Editorial: Current Good Manufacturing Practice (cGMP) Regulations, Part 5

This week, we will summarize Subpart C: Buildings and Facilities. The following are the subpart sections and a brief description of their content.

211.42 Design and Construction Features
Everything must be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations. There must be adequate space; operations must be done within specifically defined areas and designed to prevent mix-ups in a long list of procedures.

211.44 Lighting
Shall be adequate in all areas.

211.46 Ventilation, Air Filtration, Air Heating, and Cooling
Shall have adequate control over air pressure, microorganisms, dust, humidity, and temperature.

211.48 Plumbing
Shall meet appropriate standards and be adequate.

211.50 Sewage and Refuse
Shall be disposed of in a safe and sanitary manner.

211.52 Washing and Toilet Facilities
Shall be adequate, including hot and cold water, soap or detergent, air driers or single-service towels, and clean facilities.

211.56 Sanitation
Shall be maintained in a clean and sanitary condition; shall be free of infestation by rodents, birds, insects, and other vermin. There shall be written procedures assigning responsibility for sanitation activities, in detail. There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. All this also applies to work performed by contractors.

211.58 Maintenance
Shall be maintained in a good state of repair.

As an observation to this point in this series, all these standards in Subparts A, B, and C are generally contained or inferred in USP Chapters <795>, <797>, and <1163> as Good Compounding Practices.


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

About One-third of Chemotherapy Prescribed "Off-label"
A new study shows that about one-third of chemotherapies are used to fight cancers that the drug was never approved to treat. Chemotherapies are approved by the FDA for specific cancers, but there's nothing prohibiting physicians from prescribing the drugs "off-label" to treat other types of tumors.

"The main criticism of off-label prescribing has been the concern that it jeopardizes patient safety because the full risk-benefit ratio is often not completely understood," wrote the University of Toronto's Dr. Monika Krzyzanowska, who published an editorial accompanying the study in the Journal of Clinical Oncology on Tuesday. However, that doesn't mean the billions of dollars spent on off-label chemotherapies are wasted. The study authors say that their study basically highlights this proportion of use that is off-label and endorsed by expert opinion, or off-label and not endorsed by expert opinion.
http://www.reuters.com/article/2013/02/19/us-chemotherapy-idUSBRE91I18T20130219

Prescription Drug Regulation Bill Cleared by Committee
Calling it a matter of public safety, a state lawmaker convinced an Oklahoma House committee to extend state oversight to companies that act as a middleman (PBMs) between pharmacies and people filling prescriptions through their employer's health insurance. The legislation would require PBMs to get a license from the Oklahoma State Board of Pharmacy and also require them to share more information with customers about their inner workings.

The lawmaker stated "We've got somebody out there who's making life decisions for you and your constituents that are not regulated in the state of Oklahoma. They are totally unregulated." The committee approved the bill 7-3. It now moves to the full House.
http://www.sfgate.com/news/article/Panel-clears-prescription-drug-regulation-bill-4291613.php

Codeine Use for Children-Caution!
The FDA says that children shouldn't be given codeine to relieve pain after having their tonsils or adenoids removed because the medication can cause death. The FDA will soon require all codeine-containing products to carry a boxed warning to instruct doctors against use in children after such surgeries. The FDA says it has received reports of 13 deaths of children from 1969 to 2012 who had surgery and got codeine-containing drugs afterward; they found that most took place after surgery to remove tonsils and adenoids, and many of the children had sleep apnea.

Editor's Note: Thirteen deaths over 43 years? That's one death every 3.3 years. Does that really justify a "black box" warning? Just wondering!
http://online.wsj.com/article/SB1000142412788732386430457831
6383292508700.html?mod=dist_smartbrief

Vistide (Cidofovir Injection) Recall Due to Presence of Particulate Matter
Gilead Sciences, Inc. is voluntarily recalling Lot B120217A of Vistide (cidofovir injection) to the user level due to the presence of particulate matter found in some vials.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman
MedicalProducts/ucm340094.htm?source=govdelivery

Drug Information and Literature Evaluation
10th Edition
Abate MA, Blommel ML
Pharmaceutical Press; Paperback; 224 pages; $29.99

This is a volume in the Remington Education series; it is a concise guide to medical literature evaluation and the provision of medication and health information. It provides an overview of commonly used information sources available in print, online, or in mobile versions. The advantages and limitations of these sources are discussed, as well as routine database resources such as PubMed, IPA, etc. It is arranged in 12 chapters. After the discussion on resources in the first 4 chapters, the next 6 chapters progress stepwise through evaluating clinical studies. The final two chapters discuss equivalence and noninferiority studies and practice guidelines, systematic reviews, and meta-analysis. The book contains self-assessment questions along with answers. It is a great book for both students and practitioners.

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