Sales of products, mixtures, or preparations containing pseudoephedrine; reporting requirement for wholesalers
HRS §329-75
in effect329-75. Sales of products, mixtures, or preparations containing pseudoephedrine; reporting requirement for wholesalers
(a) Notwithstanding any other law to the contrary, a pharmacy or retailer may sell or distribute to a person without a prescription products containing not more than 3.6 grams per day or not more than nine grams per thirty-day period of pseudoephedrine, without regard to the number of transactions; provided that the pharmacy or retailer shall comply with the following conditions:
(1) The product, mixture, or preparation shall be
sold or distributed from an area not accessible by customers or the general
public, such as behind the counter or in a locked display case and where the
pharmacy or retailer delivers the product directly into the custody of the
person purchasing or obtaining the substances;
(2) Any person purchasing or otherwise obtaining any
product, mixture, or preparation shall produce valid, government-issued
identification containing the photograph, date of birth, printed name,
signature, and address of the person purchasing or obtaining the substance;
(3) The pharmacy or retailer shall maintain a written
or electronic log of required information for each sale of a nonprescription
product containing pseudoephedrine, including:
(A) The date and time of any transaction
under paragraph (2);
(B) The name, address, and date of birth of
the person purchasing or obtaining the substance;
(C) The type of identification provided by
the person purchasing or obtaining the substance and identification number;
(D) The agency issuing the identification
used; and
(E) The name of the compound, mixture, or
preparation, and the amount; and
(4) The pharmacy or retailer shall require every
person purchasing or obtaining the substance to sign a written or electronic
log attesting to the validity of the information. The information shall be
retained by the pharmacy or retailer for a period of two years. The written or
electronic log shall be capable of being checked for compliance against all
state and federal laws, including interfacing with other states to ensure
comprehensive compliance, and shall be subject to random and warrantless
inspection by county or state law enforcement officers.
(b) Beginning January 1, 2013, before
completing a sale of an over-the-counter product containing pseudoephedrine, a
pharmacy or retailer shall electronically submit the information required
pursuant to subsection (a) to the National Precursor Log Exchange administered
by the National Association of Drug Diversion Investigators; provided that the
National Precursor Log Exchange is available to pharmacies or retailers in the
State without a charge for accessing the system. The pharmacy or retailer
shall not complete the sale if the system generates a stop sale alert. Except
in the case of negligence, wantonness, recklessness, or deliberate misconduct,
any pharmacy or retailer using the electronic sales tracking system in
accordance with this subsection shall not be civilly liable as a result of any
act or omission in carrying out the duties required by this subsection and
shall be immune from liability to any third party, unless the pharmacy or
retailer has violated this subsection, in relation to a claim brought for such
violation.
(c) If a pharmacy or retailer selling an
over-the-counter product containing pseudoephedrine experiences mechanical or
electronic failure of the electronic sales tracking system and is unable to
comply with the electronic sales tracking requirement under this section, the
pharmacy or retailer shall maintain a written log or an alternative electronic
recordkeeping mechanism until such time as the pharmacy or retailer is able to
comply with the electronic sales tracking requirement.
(d) A pharmacy or retailer selling an
over-the-counter product containing pseudoephedrine may seek an exemption from
submitting transactions to the electronic sales tracking system in writing to
the administrator stating the reasons therefore. The administrator may grant
an exemption for good cause shown, but in no event shall the exemption exceed
one hundred eighty days. Any pharmacy or retailer that receives an exemption
shall maintain a hard copy log and shall require the person purchasing or obtaining
the substance to provide the information required under this section before
completion of any sale. The log shall be maintained as a record of each sale
for inspection by any law enforcement officer or inspector of the board of
pharmacy during normal business hours.
(e) [Subsection effective until December 31, 2023. For
subsection effective January 1, 2024, see below.] The National
Association of Drug Diversion Investigators shall forward Hawaii transaction
records in the National Precursor Log Exchange to the narcotics enforcement
division of the department of public safety weekly and provide real-time access
to National Precursor Log Exchange information through the National Precursor
Log Exchange online portal to law enforcement in the State as authorized by the
narcotics enforcement division; provided that the narcotics enforcement
division executes a memorandum of understanding with the National Association
of Drug Diversion Investigators governing access to the information; provided
further that the department of public safety narcotics enforcement division
shall establish the electronic tracking system in conjunction with the State's
existing narcotics tracking system beginning no later than January 1, 2015.
(e) [Subsection effective January 1, 2024. For subsection
effective until December 31, 2023, see above.] The National
Association of Drug Diversion Investigators shall forward Hawaii transaction
records in the National Precursor Log Exchange to the narcotics enforcement
division of the department of law enforcement weekly and provide real-time
access to National Precursor Log Exchange information through the National
Precursor Log Exchange online portal to law enforcement in the State as
authorized by the narcotics enforcement division; provided that the narcotics
enforcement division executes a memorandum of understanding with the National
Association of Drug Diversion Investigators governing access to the
information; provided further that the department of law enforcement narcotics
enforcement division shall establish the electronic tracking system in
conjunction with the State's existing narcotics tracking system beginning no
later than January 1, 2015.
(f) This system shall be capable of generating
a stop sale alert, which shall be a notification that completion of the sale
would result in the pharmacy or retailer, or person purchasing or obtaining the
substance, violating the quantity limits set forth in this section. The system
shall contain an override function that may be used by a pharmacy or retailer
selling pseudoephedrine who has a reasonable fear that imminent bodily harm
will result if the sale is not completed. Each instance where the override
function is used shall be logged by the system.
(g) No person shall knowingly purchase,
receive, or otherwise acquire products containing more than 3.6 grams per day
or more than nine grams per thirty-day period of pseudoephedrine, except that
this limit shall not apply to any quantity of such product, mixture, or
preparation dispensed pursuant to a valid prescription.
(h) Any person who violates subsection (g) is
guilty of a class C felony.
(i) The department, by rule, may exempt other
products from this section, if the administrator finds that the products are
not used in the illegal manufacture of methamphetamine or other controlled
substances. A manufacturer of a drug product may apply for removal of the
product from this section if the product is determined by the administrator to
have been formulated in such a way as to effectively prevent the conversion of
the active ingredient into methamphetamine.
(j) Notwithstanding any other provision of
this chapter to the contrary, every wholesaler shall report to the
administrator all sales made to any retailer, of any product, mixture, or
preparation containing any detectable quantity of pseudoephedrine, its salts,
optical isomers, or salts of optical isomers, as the only active ingredient or
in combination with other active ingredients. The department shall provide a
common reporting form that contains at least the following information about
the product, mixture, or preparation:
(1) Generic or other name;
(2) Quantity sold;
(3) Date of sale;
(4) Name and address of the wholesaler; and
(5) Name and address of the retailer.
(k) Intentional or knowing failure of a
retailer or pharmacy to transmit any information as required by this section
shall be a misdemeanor and shall result in the immediate suspension of that
retailer's ability to sell any product, mixture, or preparation containing any
detectable quantity of pseudoephedrine, its salts, optical isomers, or salts of
optical isomers as the only active ingredient or in combination with other
active ingredients until authorized by the administrator.
[L 2005, c 193, pt of
§1; am L 2006, c 171, §3; am L 2008, c 119, §7 and c 184, §1; am L 2012, c 119,
§1; am L 2013, c 48, §4; am L 2022, c 278, §17]
Source: Hawaii State Legislature (capitol.hawaii.gov), via Internet Archive capturesURL: http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0329/HRS_0329-0075.htmFetched: 11/10/2026