Showing posts with label 2013 by Carmen Catizone. Show all posts
Showing posts with label 2013 by Carmen Catizone. Show all posts

Monday, May 13, 2013

NABP Testimony Presented to Senate HELP Committee on May 9, 2013 by Carmen Catizone, Executive Director


Good morning Chairman Harkin, Ranking Member Alexander, and Committee members. I am
Carmen Catizone, executive director of the National Association of Boards of Pharmacy
(NABP). NABP thanks you for the opportunity to appear today and comment on the bipartisan
Draft Proposal on Pharmaceutical Compounding. NABP commends the Senate HELP
Committee for its diligence on this issue and the thoughtful approach taken in the draft proposal.
NABP is the impartial organization founded in 1904 whose members are the state agencies that
regulate the practice of pharmacy. NABP supports the state boards of pharmacy by developing,
implementing, and enforcing uniform standards for the purpose of protecting the public health.
NABP also helps state boards of pharmacy to ensure the public’s health and safety through its
pharmacist license transfer, pharmacist competence assessment, and accreditation programs.
Following the tragic meningitis outbreak caused by contaminated injectable drugs, several states
implemented compounding pharmacy inspections or conducted surveys of pharmacies, focusing
especially on those engaged in sterile compounding. As part of the NABP Compounding Action
Plan that was developed in November 2012 and implemented in December 2012, NABP
partnered with the Iowa Board of Pharmacy and other states to begin conducting inspections of
all nonresident pharmacies delivering compounded drugs into Iowa. Our initial inspections
confirmed that what occurred at NECC was also occurring at other facilities in other states. To
date, NABP has inspected approximately 150 pharmacies across the states and will continue our
inspections until all of Iowa’s approximately 600 non-resident pharmacies are inspected. In
addition to the inspection program with Iowa, NABP recently executed an agreement with the
State of New Jersey to assist with the inspection of in-state compounding pharmacies and the
prosecution of any pharmacy or individual illegally engaged in the practice of compounding.
Four other states have legislation pending or are in the process of designating NABP to conduct
or assist with inspections of pharmacies for, or in their states.
The states thank the Committee for the proposed legislation that addresses the critical concerns
identified by the states and validated by NABP and its inspections of compounding pharmacies.
As such, we welcome the clarifications provided by the proposed legislation to the regulatory
uncertainties that currently exist and were one of the primary factors leading to the recent
meningitis tragedy. Most importantly, the clarifications provide the needed distinction between
compounding and manufacturing and provide a safe and equitable environment for both
compounding and manufacturing to occur in the best interest of the patient.
Authority of the States
NABP supports a clear separation of “compounding manufacturing” from traditional pharmacy
practice and compounding. Although we would prefer that “compounding” not be included in the
proposed designation because of the inference to traditional compounding and the confusion that
could result, we understand that some terminology must be employed that describes the activity
being regulated.
The separation of compounding from manufacturing is also critical to maintain the present
authority of the states and address one of the contributing factors to the NECC crisis, ambiguous
authority between the states and the Food and Drug Administration (FDA). The provision of the
proposed legislation that specifies a compounding manufacturer cannot be licensed as a
pharmacy is essential to distinguishing from state-regulated compounding and FDA regulated
manufacturing. Our experience, and most recently our inspections of compounding pharmacies,
affirms the importance of this prohibition in clarifying what activities fall under federal
jurisdiction (FDA) and what entities can engage in compounding and operate under state
jurisdiction (state boards of pharmacy).
If a compounding manufacturer is allowed to hold dual licensure/registration, it will be more
difficult to separate the two enterprises and will provide a veil for unscrupulous entities to
obfuscate their activities. NABP supports FDA receiving authority to access any and all
documents and records required for the oversight and regulation of compounding manufacturers.
We are concerned about allowing the FDA access to pharmacy records for activities that are
regulated by the states. If an entity is manufacturing or compound manufacturing, then under the
proposed legislation and current authority, the FDA will have access to all documents and
records concerning these activities. Authorizing the FDA access to pharmacy records could
create jurisdictional conflicts with the states and impede the states from investigating or
prosecuting a case because the FDA has seized evidence or information needed by the state(s).
What is needed in lieu of allowing such access is increased communication between the states
and FDA.
NABP is collecting and maintaining data on the compounding pharmacies identified by the Iowa
Board as well as those indicated by other boards of pharmacy. Our electronic data base of e-
Profiles for pharmacies is being expanded and enriched to include all pharmacies licensed or
registered in the US by state boards of pharmacy and comparable state agencies. Data collected
from the boards and the inspection reports provided by the states and through NABP’s activities
with, or on behalf of the states, will be stored in an NABP Pharmacy e-Profile, allowing us to
disseminate pertinent information among state boards and the FDA. States are now able to
submit inspection reports and other related information to NABP for inclusion in pharmacies’ e-
Profiles. The e-Profiles for Pharmacies will be made available at no cost to boards for use in
making licensure and registration determinations for pharmacies, the FDA, and to the public for
their use in selecting an appropriate pharmacy.
Transition Period to Ensure Uninterrupted Patient Care and Necessary Exceptions
Equally tantamount to the recognition of state authority is the need to ensure an appropriate
transition period with the states as well as to recognize exceptions for activities such as the
preparation of radiopharmaceuticals. An appropriate transition period is needed so states will
have sufficient time to alert pharmacists and other practitioners and ensure that patient care is
continued and not halted by new requirements that may no longer allow certain activities that
were previously permitted under state laws. One such example is the compounding “for office
use” that is currently allowed in some states. It is our understanding that the proposed legislation
addresses this concept in different provisions and that overall the classification of such activities
is a state matter when the products prepared are distributed intra-state and a federal matter when
the products prepared are distributed in interstate commerce. If the proposed legislation is
adopted and these distinctions are correct and implemented, states will need some time to make
the adjustments in state laws in order to ensure uninterrupted patient care and close any
regulatory gaps that might result.
Intra-state Exemption from Definition of Compounding Manufacturer
NABP is also concerned with the exemption of the intra-state distribution of non-patient-specific
sterile compounded products. We support the logic of establishing a delineation point in order to
more readily identify and regulate large-scale operations that conceivably pose more risk to
patients than smaller operations. However, it is our finding that non-patient-specific, sterile
prepared products distributed intra-state bear the same risk levels to patients as products that are
introduced into interstate commerce. In fact, some intra-state operations are as large and larger
than interstate distributors of products and therefore the volume of products distributed, and the
associated risk, can be equal to or greater than the interstate distribution of similar products. The
differentiation between intra-state and interstate activities to define a compounding manufacturer
could create patient safety concerns by unintentionally creating a safe haven for entities and
individuals engaging in intra-state activities who have the intent to simply avoid the different and
federal-based requirements for interstate activities.
We ask the Committee to reconsider this provision and instead include the preparation of nonpatient-
specific, sterile prepared products for intra-state activities as a defining component of a
compounding manufacturer and within the scope of authority of the FDA.
Conclusion
As stated earlier in our statement, the other provisions of the proposed legislation that address the
safe preparation of medications and products for patients align well with the approaches
suggested and recommended by the states. The legislation proposed by the Committee
demonstrates the hard work conducted to understand a complex area of pharmacy practice that is
necessary to ensure that patients receive the appropriate medications but must also be regulated
effectively. The legislation distinguishes between compounding and manufacturing, defines a
new category of manufacturing that balances effective regulation with reality, and carefully
constructs allowances and prohibitions on the scope and activities of a compounding
manufacturer in order to meet patient needs with the necessary protections. NABP appreciates
this opportunity for input and is available to discuss our comments and the proposed legislation
in greater detail.
Thank you.