Basics of Compounding for Sterile, Nonsterile, and Quality Control Compounding: Process Analytical Technology: Appropriate for Sterile and Nonsterile Compounding?

Process analytical technology was introduced by the U. S. Food and Drug Administration about 20 years ago to assist the pharmaceutical industry in making changes that should reduce batch failures, ensure performance, and enhance quality. Its premise is that "quality cannot be tested into preparations; it must be built-in or should be by design." One proposed advantage was to reduce end-product testing by ensuring each process was functioning properly. In compounding, there are a number of processes that could be advantageously incorporated into process analytical technology since end-product testing is not generally done due to the nature of compounding. The purpose of this article is simply to introduce the concept of process analytical technology into compounding with the understanding that it will take a number of years for it to be evaluated and implemented, even on a small scale. It is not feasible to do it all at once; just one step at a time. Since patient safety is uppermost in compounding, this concept should be considered.

Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 1: Physical and Chemical Testing.

Quality control and quality assurance are vital components for successful pharmaceutical compounding. A quality program consists of proper procedures, proper documentation, proper training, and proper testing, both analytical (physical and chemical) and microbiological. Each sterile and nonsterile dosage form has a number of tests that are appropriate and some that can be easily done. Some analytical tests can be conducted in-house and some may require outsourcing. All aspects of the quality program must be documented as well as periodically reviewed and updated. A quality program is constantly being changed and improved as new technology, equipment, and procedures are implemented in the facility. The end result of a quality program should be properly compounded preparations that are safe and effective for patients.

Pharmacogenomics: Precision Pharmacy in 503A Compounding.

The first recorded mention of a pharmacogenomic response may be that of Pythagoras in 510 BC, when he noted that hemolytic anemia developed in some but not all people who ingested fava beans. The application of such accounts to pharmacotherapy was inevitable, and customized medications have been compounded since antiquity to treat the needs of individual patients. Today, advances in pharmacogenomic testing yield results that enable more effective targeted therapies sooner in the course of treatment, prevent drug-related adverse effects, save cost, and ensure a better therapeutic outcome. The value of such testing is now more widely accepted, even in the public domain. It is our opinion that third-party payors will realize, to an increasing degree, that this new technology will save them money and will pay for it. Because independent compounding pharmacists have trusted relationships with patients and are convenient to visit, they are well placed to offer certain types of pharmacogenomic tests to patients and prescribers. In this article, topics that we address include the difference between pharmacogenomics and pharmacogenetics; the use of pharmacogenomic testing in 503A compounding; the benefits of such tests for patients, prescribers, and compounders; and suggestions for marketing pharmacogenomics testing. Information about a course that introduces pharmacogenomic science to compounders is provided, and suggestions for additional reading and other resources about pharmacogenomic testing are included for easy reference.

Certification, Accreditation, and Credentialing for 503A Compounding Pharmacies.

The terms certification, accreditation, and credentialing are often used interchangeably when they apply to compounding-pharmacy qualifications, but they are not synonymous. The reasons for obtaining each, the requirements for each, and the benefits of each differ. Achieving such distinctions can negatively or positively affect the status of a pharmacy among peers and prescribers as well as a pharmacy's relationships with third-party payors. Changes in the third-party payor industry evolve constantly and, we suggest, will continue to do so. Compounding pharmacists must be aware of those changes to help ensure success in a highly competitive marketplace. To our knowledge at the time of this writing, there is no certification program for compounding pharmacists, although pharmacy technicians can achieve certification and may be required to do so by the state in which they practice (a topic beyond the scope of this article). For that reason, we primarily address accreditation and credentialing for 503A compounding pharmacies. In this article, the evolution of the third-party payment system for compounds is reviewed; the definitions of certification, accreditation, and credentialing are examined; and the benefits and recognition of obtaining accredited or credentialed status are discussed. Suggestions for selecting an appropriate agency that offers accreditation or credentialing, preparing for and undergoing an onsite survey, responding to findings, and maintaining a pharmacy practice that enables a successful survey outcome are presented. The personal experience of author CK during accreditation and credentialing is discussed, as is the role of a consultant (author BJ) in helping compounders prepare for the survey process. A list of agencies that offer accreditation and credentialing for compounding pharmacies is included for easy reference.

Basics of Compounding: 3D Printing: Pharmacy Applications, Part 3: Compounding, Formulation Considerations, and the Future.

3D printing is a standard tool in the automotive, aerospace, and consumer goods in industry and is gaining traction in pharmaceutical manufacturing, which has introduced a new element into dosage form development. This article, which represents part 3 of a 3-part article on the topic of 3D printing, discusses the compounding, formulation considerations, and the future of 3D printing.

A summarized discussion of current good manufacturing practice regulations.

In light of recent events and discussions of compounding pharmacy, it is important to discuss and understand the purpose of good manufacturing practices. This article provides a summary of the current Good Manufacturing Practice Regulations which were established by the U.S. Food and Drug Administration.

Basics of compounding: repackaging, part 2.

Compounding pharmacists who repackage commercial sterile products must be familiar with the standards set forth in the United States Pharmacopeia-National Formulary concerning this topic. Parts 1 and 2 of this two-part article examine the general chapters of the United States Pharmacopeia-National Formulary as they relate to repackaging and differentiates between commercial repackagers and pharmacists that repackage in their pharmacy for their patients.

Colds & cough.

The common cold leads to approximately 75 to 100 million physician visits annually. An estimated 22 to 189 million school days are missed annually due to a cold, which affects working parents with approximately 126 million workdays staying home to care for their children. Add this to the approximately 150 million workdays missed by employees suffering from a cold, which accounts for approximately 40% of time lost from work in the U.S., and you can see why the "common" cold is referred to as the most "common" human disease. Common colds are not a trivial health problem, as these statistics indicate, and that can be attributed to the fact that there simply is no cure for the common cold and the fact that it is highly contagious. However, the symptoms can be treated, and compounding pharmacists can work with the patient and the physician in this endeavor.

Dosage form design and development.

BACKGROUND: Drugs must be properly formulated for administration to patients, regardless of age. Pediatric patients provide some additional challenges to the formulator in terms of compliance and therapeutic efficacy. Due to the lack of sufficient drug products for the pediatric population, the pharmaceutical industry and compounding pharmacies must develop and provide appropriate medications designed for children. OBJECTIVE: The purpose of this article was to review the physical, chemical, and biological characteristics of drug substances and pharmaceutical ingredients to be used in preparing a drug product. In addition, stability, appearance, palatability, flavoring, sweetening, coloring, preservation, packaging, and storage are discussed. METHODS: Information for the current article was gathered from a literature review; from presentations at professional and technical meetings; and from lectures, books, and publications of the author, as well as from his professional experience. Professional society meetings and standards-setting bodies were also used as a resource. RESULTS: The proper design and formulation of a dosage form requires consideration of the physical, chemical, and biological characteristics of all of the drug substances and pharmaceutical ingredients (excipients) to be used in fabricating the product. The drug and pharmaceutical materials utilized must be compatible and produce a drug product that is stable, efficacious, palatable, easy to administer, and well tolerated. Preformulation factors include physical properties such as particle size, crystalline structure, melting point, solubility, partition coefficient, dissolution, membrane permeability, dissociation constants, and drug stability. CONCLUSIONS: Successful development of a formulation includes multiple considerations involving the drug, excipients, compliance, storage, packaging, and stability, as well as patient considerations of taste, appearance, and palatability.