INTRODUCTION
Compliance Policy Guidelines (CPGs) explain the U.S. Food and Drug Administration's (FDA) policy on regulatory issues concerning FDA laws or regulations. They are used to advise FDA's field inspection and compliance staffs, as well as the industry, as to the Agency's strategy and policies to be applied when determining industry compliance.

CPG's may derive from:

• A request for an advisory opinion
• A petition from outside the Agency, or
• A perceived need for a policy clarification by FDA personnel.

The statements made in a CPG are not intended to create or confer any rights, privileges, or benefits on or for any private person, but are intended for internal guidance.

CPG MANUAL
The "CPG Manual" provides an orderly method for maintaining the CPGs. The CPG manual is the repository for all agency compliance policy that has been agreed to by the center(s) and the Associate Commissioner for Regulatory Affairs.

Examples of sources from which CPGs are prepared include:

• Statements or correspondence by headquarters offices of centers reflecting new policy or changes in compliance policy including Office of the Commissioner memoranda, center memoranda and other informational issuances, agency correspondence with trade groups and regulated industries, and advisory opinions,
• Precedent court decisions,
• Multicenter agreements regarding jurisdiction over FDA-regulated products,
• Preambles to proposed or final regulations or other Federal Register documents; and
• Individual regulatory actions.

FORMAT OF CPGs

• Title
• Background
• Policy
• Regulatory Action Guidance

CPG NUMBERING SYSTEM
The CPB numbers are preceded by CPG and have numbers in the range of 7100-7199. The chapter and section numbers now indicate the chapter and location within the chapter.

NOTE: IT IS UNCLEAR WHY THERE ARE TWO DIFFERENT SOURCES OF CPGs.

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

USP Responses to <800> Questions

USP responses to the <800> questions are now in the updated <800> FAQs on the USP website and can be accessed at:
http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

News

Burkholderia cepacia Outbreak Traced to Indian Active Pharmaceutical Ingredient Maker?
FDA banned all products made by Indian drugmaker Laxachem Organics after potentially tracking an outbreak of dozens of hospital infections to one of its active pharmaceutical ingredients. In the recent outbreak of Burkholderia cepacia infections, the FDA said that it placed Laxachem Organics on its import alert list after the Ahmednagar, Maharashtra-based company refused to allow FDA investigators to inspect its facility.
http://www.fiercepharma.com/manufacturing/fda-may-have-tracked-burkholderia-cepacia-to-indian-api-maker

Teva Hungary Plant Recalling All Lots of 4 Drugs
The FDA is recalling all lots of four different injectable drugs manufactured in Hungary by a Teva plant. The recall includes 92,480 containers of antibiotic linezolid; 14,661 vials of heart surgery drug eptifibatide; 13,223 vials of anti-nausea drug ondansetron; and 1,299 bags of argatroban used for treating heparin-related complications. Recalled products were all made in Teva's plant in G�d�ll?, a relatively new facility which the company opened in 2012 to expand its injected drug capacity. Teva temporarily halted production following an FDA inspection in January that found a number of manufacturing issues.
http://www.fiercepharma.com/manufacturing/teva-recalling-all-lots-4-drugs-made-at-troubled-hungary-plant

Pfizer's Payments to Chantix Trial Doctors Altered Data?
The FDA has raised some questions about Pfizer's Chantix data review at an advisory committee meeting. FDA reviewers suggested that Pfizer's financial ties to doctors participating in the study may have biased the data. Investigators financial disclosures showed that at 32 trial sites doctors had received $25,000 or more from Pfizer, whether in speaking fees or other financial arrangements. In some of the speaking programs, the investigators were paid for speaking about Chantix.
http://www.fiercepharma.com/pharma/fda-suggests-pfizer-s-payments-to-chantix-trial-doctors-may-have-skewed-data

ADHD Drug Abuse Following Path of Opioids
The Abuse of ADHD drugs by adults is a national problem that is growing while public health officials are focused on the national plague of opioid abuse. There have been more than 19,000 reports of complications from ADHD drugs since 2013, most of which are stimulants like Adderall; of those, adults were far more likely than children to suffer severe complications, such as death and hospitalization. During this time, among those 26 and older, recreational use of Adderall increased fourfold, from 345,000 people in 2006 to 1.4 million in 2014, according to the latest available federal data.
http://www.jsonline.com/story/news/investigations/2016/09/10/abuse-adhd-drugs-following-path-opioids/89939590/

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