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HB4036 - 572R - I Ver
REFERENCE TITLE:
bulk drug substances; prohibitions
State of Arizona
House of Representatives
Fifty-seventh Legislature
Second Regular Session
2026
HB 4036
Introduced by
Representative
Pe�a
AN
ACT
AMending title 32, chapter 18, article 3,
Arizona Revised Statutes, by adding section 32-1971.01; relating to the Arizona
state board of pharmacy.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 32, chapter 18, article 3,
Arizona Revised Statutes, is amended by adding section 32-1971.01, to read:
START_STATUTE
32-1971.01.
Compounded medications; records; inspections; bulk drug
substances; prohibitions; deceptive advertising; penalties; rules; definitions
A. It is unlawful for any person or
entity to engage in the sale, transfer or distribution of a drug compounded
under section 503A of the federal food, drug, and cosmetic act (21 United
States Code section 353
a
) using a drug substance that is
a glucose-dependent insulinotropic polypeptide receptor or glucagon-like
peptide-1 receptor agonist used for obesity or weight management or a
drug substance that is a component of a similar drug approved by the united
states food and drug administration for obesity or weight management unless the
compounder of the drug:
1. Uses bulk drug substances that
comply with the standards of an applicable United States pharmacopoeia or
national formulary monograph, if a monograph exists, and the United States
pharmacopoeia chapter on pharmacy compounding or, If a national formulary
monograph does not exist, the bulk drug substances either:
(
a
) Are drug
substances that are components of drugs approved by the United States food and
drug administration.
(
b
) Appear on
the list developed by the United States food and drug
administration
pursuant to
21 United States Code section 353
a
(
b
)(1)(A)(
i
)(III)
.
2. If the labeling of a drug approved
by the united states food and drug administration specifies a process for
manufacturing the bulk drug substance, confirms that any bulk drug substance
used was manufactured according to the process prescribed by federal law.
3. Ensures that the bulk drug
substance is a pharmaceutical grade product.
4. Verifies that the bulk drug
substance is accompanied by a valid certificate of analysis.
5. Conducts and documents quality
control testing of any bulk drug substance before its use in a compounded drug
to confirm the identity and content of the bulk drug substance and the name and
quantity of each impurity present in the bulk drug substance in an amount that
exceeds one-tenth of one percent.
6. Conducts and documents quality
control testing of the finished drug product compounded in batches before
release and at expiry for any impurities derived from the use of the bulk drug
substance, including the chemical name and quantities of any such impurities.
7. Obtains proof that the manufacture
of the bulk drug substance took place in an establishment that meets all of the
following:
(
a
) Is duly
registered with the United States food and drug administration pursuant to 21
United States code section 360.
(
b
) Has
undergone an inspection by the United States food and drug administration as a
human drug establishment within the last two years.
(
c
) Is not
subject to an import alert by the United States food and drug administration.
8. Complies with the federal food,
drug, and cosmetic act.
B. It is unlawful for any
manufacturer or wholesaler to sell, transfer or distribute a bulk drug
substance in this state for use in compounding without providing to the
purchaser:
1. written verification that the bulk
drug substance is pharmaceutical grade and meets the sourcing requirements.
2. documentation of any quality
control testing and the valid certificate of analysis as required by subsection
A, PARAGRAPH 4 of this section.
C. Any person or entity engaging in
the sale, transfer or distribution of compounded drugs pursuant to subsection A
of this section shall maintain all records related to the acquisition,
examination and testing of the bulk drug substance for at least two years after
the expiration date of the last lot of drug containing the bulk drug substance
and, on request by the board, shall furnish the records to the board within one
business day after receiving the request or within a reasonable time as
determined by the board based on the circumstances of the request.
D. The board or the board's
authorized agent has the authority to inspect any person or entity that engages
in compounding drugs, as well any domestic supplier, wholesaler, repackager or
other provider of the bulk drug substance for compounding, for compliance with
the requirements prescribed in subsection A of this section.� Refusal to allow
the board or the board's authorized agent access to conduct an inspection
constitutes a violation of this section.
E. It is unlawful for any person to
advertise or otherwise promote compounded medications unless the advertisement
is truthful and not misleading. An advertisement is not truthful and
is misleading if it includes any unsubstantiated claim with respect to the
product. An advertisement is misleading unless it contains all of
the following:
1. A disclosure of the potential side
effects, adverse reactions, contraindications, precautions and warnings
associated with active ingredients in the medication, including any noted from
clinical trials, research and other appropriate information sources.
2. A summary of the specified risk
information in the labeling of the United States food and drug administration-approved
drug, if applicable, if the compounded drug contains an active ingredient that
is named as an active ingredient in a United States food and drug
administration-approved drug.
3. if applicable, A clear,
conspicuous statement that the product is a compounded medication, has not been
approved by the United States food and drug administration and has not been
evaluated by the United States food and drug administration for safety or
efficacy.
F. In addition to any other penalties
prescribed in this chapter, a person or entity that violates this section may
be subject to:
1. A civil penalty of $1,000 per dose
of the illegally compounded drug sold, transferred or distributed.
2. A suspension or revocation of the
licensee's or permittee's license or permit, as applicable.
G. The board shall adopt rules as
necessary to implement this section.
H. For the purposes of this section:
1. "Bulk drug substance":
(
a
) Means any
substance that is intended for incorporation into a finished drug product and
that is intended to furnish pharmacological activity or another direct effect
in the diagnosis, cure, mitigation, treatment or prevention of a disease, or to
affect the structure or any function of the body.
(
b
) Does not
include intermediates used in the synthesis of the substance.
2. "Person" means any
individual, partnership, firm, corporation or other legal entity.
3. "Unsubstantiated claim"
means any statement, representation or assertion concerning the safety,
efficacy or other attributes of a drug that is not supported by competent and
reliable scientific evidence.
END_STATUTE
Sec. 2.
Legislative findings
The legislature finds the following:
1. The safety and integrity
of compounded medications are paramount for the health and well-being of residents
of this state.
2. The United States food
and drug administration sets internationally recognized standards for drug
approval and regulatory oversight.� However, there have been increasing
attempts by unscrupulous actors to circumvent these regulations, undermining
public trust and patient safety.
3. Foreign entities,
including those from countries such as China, have exploited regulatory gaps to
introduce inferior or contaminated active pharmaceutical ingredients into the
supply chain for medications intended for compounding.
4. Recent cases, such as
those involving medications for weight loss, have demonstrated that high demand
can lead to the proliferation of use of illicit, substandard and potentially
harmful active pharmaceutical ingredients, also known as bulk drug substances,
jeopardizing patient health and safety.
5. While the United States
food and drug administration bears responsibility for enforcing federal laws to
protect citizens from misbranded and adulterated pharmaceutical ingredients,
enforcement has proven insufficient to curtail the influx of these substances.
6. Even after the United
States food and drug administration took some action to curb imports of active
pharmaceutical ingredients for weight loss medications from entities that are
not compliant with current good manufacturing practice requirements, patients
in this state remain at risk of receiving compounded medications containing
active pharmaceutical ingredients produced by entities that the United States
food and drug administration found to not be compliant with those requirements,
including active pharmaceutical ingredients imported into the United States
before the United States food and drug administration took action.
7. Therefore, it is
necessary for this state to take action to protect its residents by ensuring
that all active pharmaceutical ingredients used in compounding are sourced from
reputable, registered and inspected establishments, and that only pharmaceutical
grade, safe and pure ingredients are used in medications for weight loss.