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10/23/2003

ASHP Submits Testimony at Senate Hearing on Compounding

Kate Traynor

ASHP's Government Affairs Division today submitted written testimony to the Senate Committee on Health, Education, Labor, and Pensions for its hearing "Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients." Committee members Christopher Bond (R-Mo.) and Pat Roberts (R-Kan.) requested the hearing to examine what they consider to be the growing drug-compounding industry and assess the adequacy of regulatory oversight.

The American Society of Health-System Pharmacists (ASHP) is pleased to submit this statement for the record of the Senate Health, Education, Labor, and Pensions Committee hearing on pharmacy compounding. ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, long-term care facilities, home care, hospice, health maintenance organizations, and other components of health care systems.

ASHP is as concerned as this committee about inappropriate and fraudulent behaviors that have placed patients at risk of harm from their medications. One must distinguish however, between an intentional criminal act and pharmacy compounding.

ASHP has a long history of promoting safe medication use and has developed practice standards for pharmacy compounding in hospitals and other components of health systems. We foster the application of those standards through various articles published in our peer-reviewed, professional practice journal, and through educational sessions featured at our clinical meetings.

In an effort to help assure patients receive safe and appropriate medications, ASHP recognizes the need to collect additional information about all medication distribution systems, including compounded preparations. It is important to fit this examination into the proper regulatory framework.

ASHP strongly supports the current regulatory system, with state boards of pharmacy regulating pharmacy compounding and the FDA regulating the manufacturing of drug products. This regulatory framework is consistent with the way other health professions are regulated and is effective.

Throughout this testimony we will look at the nature and extent of pharmacy compounding and the system for regulating this practice. We will also examine ways to continue to improve the safety of the medication system.

Origins of This Hearing Not Compounding

It is important to note that the origins of this hearing stem not from the practice of compounding as described below, but rather from the fraudulent and criminal acts of a Kansas City pharmacist who intentionally diluted the potency of chemotherapy drugs for his own economic gain. This pharmacist's actions were inexcusable, indefensible, and an embarrassment to the profession. His actions are not representative of the necessary, accurate, and admirable compounding that pharmacists perform everyday for patients in hospitals and health systems.

As the committee assesses the adequacy of current regulatory framework, it must not overlook this fact. The current justice and regulatory system is well-designed to deal with criminal action.

Pharmacy Compounding Today

The practice of compounding is an important and long-standing component of the pharmacy profession. In the early days of medicine, compounding frequently occurred because there were few commercially available products. Today, compounding allows pharmacists to customize manufactured products to meet individual patient needs or to create necessary alternatives to commercially available products

Compounding occurs when a medication is prepared by combining, mixing, or altering two or more ingredients, or components, for a patient based on the receipt of a valid prescription or in anticipation of prescriptions based on the medication order history from the pharmacist-physician-patient relationship.

Pharmacists in health system settings generally prefer not to compound if there is a viable product commercially available, since compounding requires extra time, staff training, proper equipment, and other important quality control measures. However, proper patient care requires the compounding of certain medications. In fact, in hospitals, many commercially available products require compounding processes to prepare them for administration.

It is impossible for manufacturers to meet every conceivable patient need. For example, the variety of doses needed for geriatric and pediatric patient populations or the customization of intravenous fluids needed to correct a given patient's blood-chemistry deficiencies.

Further, manufacturers cannot manufacture certain items. The classic example of this is a sterile fluid for intravenous feeding of patients ("parenteral nutrition"). While manufacturers covet this large potential market, they have not been able to manufacture a stable product. The moment the necessary concentration of glucose and protein are mixed together, the ingredients begin to decompose. Parenteral nutrition has been an established therapy for 35 years, but manufacturers have not been able to resolve this chemical stability problem and provide a usable product to the health systems caring for these patients. Hence, pharmacists (for example in hospitals and home care) must do the compounding. For many patients, this is literally life-saving therapy.

Medications are also compounded when a prescriber determines, in his or her professional judgment, that the use of a compounded preparation is necessary. For example, when a patient cannot use a commercially available product due to an allergy to one of the ingredients—sensitivity to the dye used for coloring, lactose, or other excipients used in many classes of drugs. Or, when a patient cannot swallow tablets or capsules and the drug can be transformed into a liquid, lozenge, suppository, or other form.

The compounding of medications that would not have been otherwise available has saved many lives. This is thanks to the dedication, skill, and professional judgment of pharmacists. It is clearly within the public interest to preserve this important practice.

Regulatory Oversight of Pharmacy Compounding is Well Established

The federal Food, Drug, and Cosmetic Act of 1938 (FDCA) was created to regulate drug manufacturing, marketing, and distribution, not compounding or pharmacy practice. The Food and Drug Administration Modernization Act of 1997 (FDAMA), which ASHP worked with Congress to develop, reinforced the legitimacy of pharmacy compounding as a state regulated activity and clarified the inapplicability of the FDCA to compounding. Although the compounding provision of FDAMA was overturned by the Supreme Court in 2002 due to its constraints on advertising, this should not eliminate the line between federal and state jurisdiction.

The oversight of pharmacy practice by state regulatory authorities is well established. States, through their boards of pharmacy, determine the education and licensure requirements of pharmacists, as well as licensure requirements for pharmacies. State boards of pharmacy have the authority to take disciplinary action, including license revocation or suspension, against pharmacists for misconduct or failure to abide by state laws or regulations, including those pertaining to pharmacy compounding. This is equivalent to the way physicians and other health care professionals are regulated.

The role of enforcing the application of specific quality assurance standards in pharmacy practice is one that is well established in law and in practice for state boards of pharmacy. The FDA recognized this in its December 28, 1998, draft "Memorandum of Understanding on Interstate Distribution of Compounded Drug Products." In that document the agency states that "the standard MOU also reflects FDA's policy to defer to State and local officials for the regulation of the day-to-day practice of pharmacy, to the extent permitted under the federal Food Drug and Cosmetic Act."

The state boards of pharmacy are admittedly at different stages in their efforts to regulate compounding practice, with some states aggressively addressing good compounding practice. California, for example, has adopted regulations establishing standards for compounding injectable preparations, requiring special licenses for those who prepare sterile formulations, and increasing investigation of compounding pharmacies.

Other states may need to continue to strengthen their regulatory authority of pharmacy compounding. Over the past few years, public awareness of pharmacy compounding has grown and many states are in the process of addressing the issue. The National Association of Boards of Pharmacy (NABP), in a continued effort to provide guidance to the states, has strengthened its model practice act on compounding.

The United States Pharmacopeia (USP) has also promulgated a revised chapter on the compounding of sterile products, known as General Tests and Assays Chapter 797 or "Pharmaceutical Compounding—Sterile Preparation." Beginning January 1, 2004, this chapter could be enforced by state boards of pharmacy if adopted by state statute or regulation and cited during visits by FDA and accreditation personnel. This chapter provides a standard for sterile compounding. The USP also provides a similar standard on non-sterile compounding.

Build Upon the Current Federal–State Partnership

Much can be done to build upon the existing federal–state partnership to ensure patient safety. For example, ASHP strongly supports the development and widespread distribution of minimum standards and appropriate guidance for pharmacists and others on pharmacy compounding. While ASHP believes state boards of pharmacy are the appropriate body to enforce compounding standards, the FDA has a role to play in ensuring that the state boards fulfill this responsibility through the state adoption of uniform standards. ASHP believes that it is appropriate for the FDA to suggest to state boards the standards that the states should apply. This will foster the establishment of a national quality assurance standard for compounding in all pharmacy settings, rather than 50 different standards. The use of both the USP chapters and ASHP guidelines on sterile and non-sterile compounding, as well as the latest scientific knowledge in the literature, would provide the assurance the Committee is seeking for the safety and effectiveness of these preparations.

The FDA could also play an important role in bolstering state enforcement efforts. State boards have limited resources to hire inspectors and to train them properly. The FDA could offer a training program for state inspectors enforcing the minimum national standards for compounding practice. This could be run similar to the federal program whereby states receive dollars to help maintain their roads when the state chooses to enforce the 65 mile per hour speed limit. The FDA should also have clear procedures for state inspectors to call in the FDA when activities seem to border on manufacturing.

Finally, it would be beneficial if there was more clarity and consistency in the definitions of compounding and manufacturing. When section 127 of FDAMA was overturned, this became less clear. In the policy compliance guide on pharmacy compounding issued by the FDA in June 2002, the FDA identified nine factors that it would use collectively to determine when the scope and nature of activities raise the kinds of concerns normally associated with drug manufacturing. In the FDA's revision of the compliance policy guide, it may be helpful if the FDA provides a definition of what actually constitutes manufacturing rather than just providing examples of what oversteps the bounds of "traditional pharmacy compounding." The USP in its draft chapter 1075, "Good Compounding Practice," also provides a definition for compounding and manufacturing. The FDA and USP should be encouraged to coordinate finalization of their respective compliance guides and chapters so that their definitions and criteria for compounding and manufacturing are consistent.

Conclusion

The existing federal–state partnership provides a good framework for regulating medication distribution, including compounded preparations. This committee should build on the existing framework in the ways suggested above rather than adding additional federal regulatory oversight.