Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA.

In the U.S., determining whether it is legal to compound with a particular substance for human patients is governed by a patchwork of laws, regulations, and U.S. Food and Drug Administration guidance. Furthermore, there is no single, unified source where a compounder can determine whether a particular substance is legal to compound with. This article provides 503a compounders a step by- step tool to evaluate the legality of compounding with a particular substance for human patients. It does so in a systematic way that considers the patchwork of law, regulations, and U.S. Food and Drug Administration guidance documents that must be considered.

Performing a United States Pharmacopeia Chapter <800> Compliant Assessment of Risk.

United States Pharmacopeia Chapter <800>, which became effective on December 1, 2019, addresses handling of hazardous drugs in facilities that make compounded preparations. The Chapter includes minimum facility, engineering controls, personal protective equipment, and other requirements under which all hazardous drugs must be handled. For certain hazardous drugs, an assessment of risk may be performed to determine alternative containment strategies or work practices. This article addresses the legal enforceability of Unites States Pharmacopeia Chapter <800>, how to determine whether a drug is eligible for an assessment of risk, and details important considerations when performing assessments of risk.

Root Cause Analysis, Part 2: STERILE COMPOUNDING.

When an adverse event or near miss occurs in a pharmacy, eliminating the root cause to prevent recurrence is critically important. Addressing the root cause of the problem reduces the recurrence of putting patients and the pharmacy at risk. This article proposes a method for performing Root Cause Analysis applicable to sterile compounding.

New England Compounding Center Indictment.

This article is a review of the lapses in compliance with United States Pharmacopeia standards and pharmacy law as alleged by the New England Compounding Center indictment. This indictment was a result of an outbreak of fungal meningitis traced to fungal contamination of compounded methylprednisolone suspension for epidural steroid injections. This article is also intended as a gap analysis for compounders to review compliance at their own facility, and, if necessary, take the appropriate steps to implement best practices.

Root Cause Analysis, Part 1: Nonsterile Compounding.

When an adverse event or near miss occurs in a pharmacy, eliminating the root cause to prevent recurrence is critically important. We occasionally see pharmacies address deviations in a manner that only superficially addresses the adverse event, but does not address the root cause of the problem, thereby putting patients and the pharmacy at risk of a recurrence. This article proposes a method for performing Root Cause Analysis.

Quality-control analytical methods: aqua pura: water purification systems and United States pharmacopeia waters for the compounding pharmacy, part 1.

The types of water used most often in a compounding pharmacy are potable water, purified water, and sterile water (water for injection or irrigation). Of those three types, purified water is most frequently used; it is essential as a clean glassware rinse and is used in the compounding and reconstitution of frequently prescribed no sterile compounds, such as antibiotic suspensions. Using the appropriate water is absolutely essential to good compounding practice. Purified water cannot be substituted for sterile water for irrigation or injection, and if the last step in washing glassware and pharmaceutical implements is not a thorough purified-water rinse, the cross-contamination of preparations with drugs or chemicals (the presence of which can be missed even during potency testing) can occur. In this first of a series of three articles, we briefly review the types of United States Pharmacopeia water used most frequently in compounding, discuss the basic types of water purification systems that can be used in a compounding, discuss the basic types of water purification systems that can be used in a compounding pharmacy, and answer questions about water purification systems that are of interest to compounding pharmacists. Part 2 will provide current information from the United States Pharmacopeia about various waters, and part 3 will present testimonials from compounders who are using an in-house water purification system and additional information about water purification systems from manufacturers or vendors of that equipment (a Table comparing various water purification systems will be included for easy reference).

Quality Control, Quality Assurance, and Quality Improvement-What is the Difference and Why Should Compounding Pharmacies Care?

This article provides scenarios of three different pharmacies in the areas of quality control, quality assurance, and quality improvement. The scenarios show the importance that each pharmacy placed on a problem of dented capsules and the potential impact that an unresolved problem can have on a compounding pharmacy's business. Although this article focuses on one particular procedure, the purpose of th article is to help pharmacists understand the differences between quality control, quality assurance, and quality improvement.

Obtaining accreditation by the pharmacy compounding accreditation board, part 3: developing a program of qualtity assurance and continuous qualtiy improvement.

Before a compounding pharmacy can receive accreditation from the Pharmacy Compounding Accreditation Board, the pharmacy must show evidence of both quality assurance activities and continuous quality improvement activities. Although quality assurance data gathering and monitoring can be integrated into pharmacy activities fairly easily, the coninuous quality improvement program may take a little more time and effort to implement . Before integrating these programs, compounding pharmacists must have a complete understanding of the differences between these two programs. Even if accreditation with the Pharmacy Compounding Accreditation Board is not being considered, it is important that compounding pharmacies have these two programs implemented. In the long run, it will pay off in higher quality services, error prevention, and perhaps greater efficiency of pharmacy operations.

Microbial air-sampling equipment, part 2: experiences of compounding pharmacists.

The most recent changes to Chapter 797 of the United States Pharmacopeia-National Formulary initiated an intense controversy about the frequency of cleanroom air sampling that is required to prevent the contamination of sterile preparations. For compounders who must purchase an air sampler to use in the cleanroom, choices abound. This article summarizes discussions from compounding pharmacists and their experiences with air sampling devices.

Obtaining accreditation by the pharmacy compounding accreditation board, part 4: tips for "last minute" preparations.

One of the most exciting new developments in the world of compounding is the opportunity for a pharmacy to obtain accreditation. Other healthcare organizations have had that opportunity for years. Compounding pharmaies now have an external standard-setting entity to which they can apply for accreditation-the Pharmcy Compounding Accreditaion Board-and they are encouraged to do so. The pharmacy staff may have extra anxiety the few days before a survey is conducted by the Pharmacy Compounding Accreditation Board, but, by following the pre-survey tips included in this article, compounding pharmacists and their staff can channel the extra energy into productive activites that will help in achieving accreditation.

Obtaining accreditation by the pharmacy compounding accreditation board, part 2: developing essential standard operating procedures.

A key component of qualifying for accreditation with the Pharmacy Compounding Accreditation Board is having a set of comprehensive standard operating procedures that are being used by the pharmacy staff. The three criteria in standard operating procedures for which the Pharmacy Compounding Accreditation Board looks are: (1)written standard operating procedures; (2)standard operating procedures that reflect what the organization actualy does; and (3) whether the written standard operating procedures are implemented. Following specified steps in the preparation of standard operating procedures will result in procedures that meet Pharmacy Compounding Accreditation Board Requirements, thereby placing pharmacies one step closer to qualifying for accreditation.

Obtaining accreditation by the pharmacy compounding accreditation board, part 1: an overview.

An organization's performance is constantly compared with that of other similar businesses and is challenged to comply with industry standards. Accreditation by an external standard-setting body officially sanctions a business and differentiates it from competitors. Various industries have external standard-setting entities to which they can apply for accreditation. Compounding pharmacists are encouraged to seek accreditation by the Pharmacy Compounding Accreditation board. The accreditation process may seem daunting, but it can be simplified and more clearly understood if you divide the application procedure into sections, involve your entire pharmacy staff, and discuss the application prodedure with past applicants. One of the most exciting new developments in the world of compounding is the opportunity for a pharmacy to obtain accreditation. Other healthcare organizations have had that opportunity for years: Hospitals are accredited by the Joint Commission on Accreditation of healthcare Organizations (JCAHO); home care organizations are credentialed by both the Accreditation Commission for Health Care, Inc., and the JCAHO; and health management organizations and preferred provider organizations are accredited by the National Council for Quality Assurance. All those industry segments have realized the value of measuring their organization's performance against national standards. The first question that a compounder may ask is, "Why is accreditation important?" For me, the answer is simple. I have yet to see pharmacy advertising that states, "Our pharmacy meets minimal standards and we have the least qualified staff in town." Every pharmacy says that it is excellent. However, because of certain current media issues (steroid scandals American Medical Association resolutions, congressional hearings), compounders must prove to physicians and patients that their pharmacy meets a high standard, and accreditation by the Pharmacy Compounding Accreditation Board (PCAB) is that proof of quality. Athough acquiring accreditation by the PCAB is a great opportunity for differentiating your pharmacy from others, extensive preparation may be required to achieve full compliance with the specified standards. This article addresses some of the questions posed by compounders about accreditation, such as: How do I initiate the process of application for accreditation? What is required during that process? Which standard operating procedures (SOPs) are required? How much time will be required? Will I need to change what we do? What do ceratin standards mean? What will the survey process be like? How long does the preparation preocess take? How does a compounding pharmacy prepare for accreditation?

Flavoring meds for children and adults so it goes down easy!

This article explores the options available to flavor medications, including using pantry and refrigerator items, some infant dosing gadgets, pharmacy flavorings, and compounded medications. And don't forget, the tips and tricks in this article should work for that occasional difficult adult who still thinks and acts like a kid!

The compounding pharmacist: a home care and hospice partner.

Home care and hospice nurses see difficult medical problems requiring individualized treatment and medication strategies. This article provides the basics of how a specialized type of pharmacy practice--the compounding pharmacy--can become invaluable to your care team.