Second Regular Session S.B. 1103
PROPOSED AMENDMENT
SENATE AMENDMENTS TO S.B. 1103
(Reference to printed bill)
Strike everything after the enacting clause and insert:
"Section 1. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1979, to read:
32-1979. Compounding; substances; pharmacies; jurisdiction; regulation
A. When the board makes a determination of whether a substance may be compounded, the board shall consider all of the following:
1. The United States food and drug administration advisory on compounding substances, but the board is not bound by the advisory.
2. Whether a substance has historically and safely been used in compounding in this state.
3. Whether the substance is quality controlled and possesses a valid certificate of analysis.
4. Whether the substance is contained in a pharmacopeia of the United states or another recognized nation.
5. Any other factor the board deems appropriate to carry out its mission to protect the public health, safety and welfare.
B. The board has exclusive jurisdiction to regulate compounding pharmacies in this state, including the determination of whether a substance that is used in compounding and that is lawfully prescribed by a health care practitioner is allowed or prohibited.
Sec. 2. Findings
The legislature finds that:
1. The Arizona Constitution recognizes the right of the people to make decisions about their health care.
2. Licensed health care practitioners in this state have the right to help their patients make informed decisions about health care by speaking freely to their patients and using their best medical and clinical judgments based on training and experience to recommend, prescribe and treat patients consistent with best practices and historically recognized standards of care consistent with their licensed scope of practice.
3. Licensed health care practitioners' individualized recommendations, prescriptions and treatments are vital elements of practice required to meet patients' specific needs and to achieve the most successful outcomes.
4. Traditional compounding pharmacy is a practice historically recognized and embedded in our nation's history and is an essential component to the individualized practice of medicine for health care practitioners.
5. Traditional compounding pharmacy is an essential element to the practice of medicine and is not the manufacture of drugs.
6. The United States food and drug administration regulates the manufacture and approval of drugs, biologics and devices.
7. The United States food and drug administration does not have the authority to regulate the practice of medicine or any elements thereof.
8. The practice of medicine, including traditional compounding pharmacy, has traditionally and uniformly been regulated under a state's police powers.
9. States have great latitude in regulating medical practice and standards, which are primarily and historically a matter of local concern."
Amend title to conform