Quality commitment starts at the top and involves all individuals in the organization. The intent of a quality system in a pharmacy is to insure adequate controls throughout the compounding and dispensing process. The heart of any quality system is the written and approved documentation that is followed in the day-to-day operation of the pharmacy by the personnel involved.

Failure/error often occurs when individuals: (1) do not know their responsibilities, (2) have not been provided the training needed, (3) have not been provided the resources needed, (4) do not take their responsibilities seriously.

A good document system does not always guarantee a good quality system, but it can help in minimizing errors and failures.

Documents are written to link people with operational responsibilities. Standard Operating Procedures (SOPs) are documents that describe how to perform routine tasks in the environment of formulation development, purchasing, compounding, testing, maintenance, materials handling, quality assurance, and dispensing. They contain step-by-step instructions to perform tasks reliably and consistently.

Written procedures should exist for all compounding, quality control, packaging, and labeling processes. Master Formula Records should be written to provide adequate instruction and documentation of the compounding operation. Documentation should provide for safety, cleaning, maintenance, and care of the facility and all equipment. All SOPs shall be approved by qualified individuals and should be kept current and updated.

Data collection forms are documents that should be completed while performing the routine tasks directed by the SOPs. They may include "fill-in-the-blank" spaces for the collection of data and may also include logbook entries, data printouts, and reports.

The purpose of SOPs is to answer the questions: (1) How is the task to be performed? (2) Who will do the task? (3) Why it will be performed? and (4) Are their any limitations?

SOPs may be written by the pharmacists and technicians responsible for performing the procedure. SOPs often contain the following components:

• Title/Number
• Purpose/Scope
• Responsibility
• Equipment/Supplies Required
• Process/Procedures
• Company Information
• Signatures/Authors/Responsible Persons

When writing SOPs, they should be reviewed and revised until they correctly reflect what actually needs to be done.

Usually, SOPs are categorized so they can be easy to find and use. Although there is no set categorization of SOPs, some categories may include the following:

• Administration
• Personnel
• Training
• Safety
• Facility-Environmental and Maintenance
• Facility-Cleaning
• Equipment
• Compounding Procedures
• Quality Assurance
• Inventory Control
• Reference Documents
• Veterinary Compounding

IJPC's November/December 2006 issue on veterinary compounding included an article titled Compounding for Veterinary Medicine, written by Shannon W. Fields, BA, CPhT. IJPC received a call from a veterinary compounding pharmacist complementing the journal and the author on this excellent article. Paraphrasing the words of the pharmacist, although brief, this article summarizes what veterinary compounding is all about and how challenging it is to appropriately dose veterinary patients. Read this article on pages 417 through 418. Readers will also find articles related to topics other than veterinary medicine in the issue. If you are not a subscriber you can purchase and download a specific article at http://www.ijpc.com/backissues/ArticleDescription.cfm?ABS=2490

Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists (IACP). For more information, www.iacprx.org.

The FDA appealed the Midland decision to the Federal Fifth Circuit Court of Appeals. The federal district judge in Midland, Texas, had ruled in a landmark victory for pharmacy compounding that "compounded drugs do not fall under the new drug definitions" and, as a result, are legal. The Court further ruled that pharmacies are exempt from the requirement to submit to an FDA inspection of their records unless FDA can demonstrate that the pharmacy is not compliant with applicable state laws and does not operate as a retail pharmacy. Finally, the Court ruled against FDA and declared that compounding from bulk pharmaceutical ingredients for non-food animals is legal.

The Fifth Circuit covers Texas, Louisiana and Mississippi. A Federal Circuit Court decision has significant legal weight--especially in the absence of a contrary decision in another circuit. An appeal following a Circuit decision would go to the U.S. Supreme Court. IACP will continue to work with the plaintiff attorneys in this case and provide briefs to support their case against FDA's theory that all compounding is illegal and subject to FDA's approval process and manufacturing requirements. Check our website regularly for updated information at www.iacprx.org

The cover artwork of the International Journal of Pharmaceutical Compounding's premiere issue is an electronically generated representation of the evolution of compounding pharmacy and the history of individualized patient care.

You can purchase a copy of this poster where the best of both worlds of pharmacy's past & future are together at www.ijpc.com/Products/ProductDescription.cfm?PID=11

SOPs are Key!
Well-written, implemented, and documented SOPs and associated records are one of your best defenses in case something goes wrong in the pharmacy. Maintain accurate and detailed records. Visit www.CompoundingToday.com for over 300 SOPs written in Microsoft Word format that can be easily modified to your specific needs.