SB 878 — Modifies provisions relating to pharmaceutical drugs and devices

8.

No prescription shall be required for the dispensation, sale, or distribution of any drug product containing any detectable amount of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts or optical isomers, or salts of optical isomers, in an amount within the limits described in subsections 2, 3, and 4 of this section.

The superintendent of the Missouri state highway patrol shall report to the revisor of statutes and the general assembly by February first when the statewide number of methamphetamine laboratory seizure incidents exceeds three hundred incidents in the previous calendar year.

The provisions of this subsection shall expire on April first of the calendar year in which the revisor of statutes receives such notification.

HCS SS SCS SB 878 5 [8.] 9.

This section shall supersede and preempt any local ordinances or regulations, including any ordinances or regulations enacted by any political subdivision of the state.

This section shall not apply to the sale of any animal feed products containing ephedrine or any naturally occurring or herbal ephedra or extract of ephedra.

[9.] 10.

Any local ordinances or regulations enacted by any political subdivision of the state prior to August 28, 2020, requiring a prescription for the dispensation, sale, or distribution of any drug product containing any detectable amount of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts or optical isomers, or salts of optical isomers, in an amount within the limits described in subsections 2, 3, and 4 of this section shall be void and of no effect and no such political subdivision shall maintain or enforce such ordinance or regulation.

[10.] 11.

All logs, records, documents, and electronic information maintained for the dispensing of these products shall be open for inspection and copying by municipal, county, and state or federal law enforcement officers whose duty it is to enforce the controlled substances laws of this state or the United States.

[11.] 12.

All persons who dispense or offer for sale pseudoephedrine and ephedrine products, except those that are excluded from Schedule V in subsection 17 or 18 of section 195.017, shall ensure that all such products are located only behind a pharmacy counter where the public is not permitted.

[12.] 13.

The penalty for a knowing or reckless violation of this section is found in section 579.060.

HCS SS SCS SB 878 6 (1) The interpretation, implementation, and evaluation of medical prescription orders, including any legend drugs under 21 U.S.C.

EXPLANATION-Matter(4) enclosedThe inordering bold-faced brackets [thus] in this bill is not enacted and isadministration intendedof tovaccines beapproved omittedor inauthorized by the law.U.S.

SSFood SCSand SBDrug 878Administration, 2as (4)of TheJanuary ordering1, and2026, administrationor ofthereafter, excluding vaccines for cholera, monkeypox, Japanese encephalitis, typhoid, rabies, yellow fever, tick-borne encephalitis, anthrax, tuberculosis, dengue, Hib, polio, rotavirus, smallpox, [and any vaccine approved after January 1, 2023] or authorizedany vaccine that is not jointly included by joint rules promulgated by the board of pharmacy and the state board of registration for the healing arts for vaccines approved by the U.S.

Food and Drug Administration,Administration as of January 1, 2026, or thereafter, excluding vaccines for cholera, monkeypox, Japanese encephalitis, typhoid, rabies, yellow fever, tick-borne encephalitis, anthrax, tuberculosis, dengue, Hib, polio, rotavirus, smallpox, [and any vaccine approved after January 1, 2023]2026, or any vaccine that is not jointly included by joint rules promulgated by the board of pharmacy and the state board of registration for the healing arts, to persons at least seven years of age or the age recommended by the Centers for Disease Control and Prevention, whichever is older, pursuant to joint promulgation of rules established by the board of pharmacy and the state board of registration for the healing arts unless rules are established under a state of emergency as described in section 44.100;

HCS SS SCS SB 878 7 (6) The proper and safe storage of drugs and devices and the maintenance of proper records thereof;

SS SCS SB 878 3 2.

HCS SS SCS SB 878 8 5.

Nothing in this section shall be construed as to prevent any person, firm or corporation from owning a SS SCS SB 878 4 pharmacy regulated by sections 338.210 to 338.315, provided that a licensed pharmacist is in charge of such pharmacy.

The state board of registration for the healing arts, under section 334.125, and the state board of pharmacy, under section 338.140, shall jointly promulgate rules regulating the use of protocols for medication therapy HCS SS SCS SB 878 9 services.

This section and chapter 536 are nonseverable and SS SCS SB 878 5 if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2007, shall be invalid and void.

Any pharmacist who has received a certificate of medication therapeutic plan authority may engage in the HCS SS SCS SB 878 10 designing, initiating, implementing, and monitoring of a medication therapeutic plan as defined by a written protocol from a physician that may be specific to each patient for care by a pharmacist.

"Veterinarian", "doctor of veterinary medicine", "practitioner of veterinary medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (Vet Science)", "VMB", "MRCVS", or an equivalent title means a person who has received a doctor's degree in veterinary medicine from an accredited school of SS SCS SB 878 6 veterinary medicine or holds an Educational Commission for Foreign Veterinary Graduates (EDFVG) certificate issued by the American Veterinary Medical Association (AVMA).

In addition to other requirements by the board, a pharmacist shall receive additional training as required by the board and evidenced by receiving a certificate from the HCS SS SCS SB 878 11 board upon completion, and shall display the certification in his or her pharmacy where vaccines are delivered.

SS SCS SB 878 7 (2) The identity of the vaccine or vaccines administered;

A pharmacist with a certificate of medication therapeutic plan authority may provide influenza, group A streptococcus, and COVID-19 medication therapy services pursuant to [a statewide standing order issued by the director or chief medical officer of the department of health and senior services if that person is a licensed HCS SS SCS SB 878 12 physician, or a licensed physician designated by the department of health and senior services] rules established by the board of pharmacy and the state board of registration for the healing arts, as described in this section.

Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective SS SCS SB 878 8 only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028.

(1) Is a device classified by the UnitedU.S. States Food and Drug Administration as a Class I or Class II under 21 U.S.C.

SectionFood 360 and itsDrug implementingAdministration regulationsas undera 21Class CFRI Partsor 860Class toII 892;device under 21 U.S.C.

(2)Section Is360c primarily and customarilyits usedimplementing toregulations serveunder a21 medicalCFR purpose;Parts 860 to 892;

HCS SS SCS SB 878 13 (2) Is primarily and customarily used to serve a medical purpose;

The state board of registration for the healing arts, pursuant to section 334.125, and the board of pharmacy, pursuant to section 338.140, shall jointly promulgate rules to implement the provisions of this SS SCS SB 878 9 section.

Such rules shall be written and effective within six months of the effective date of this act.section.

Notwithstanding any other provision of law to the contrary, a pharmacist may dispense ivermectin and hydroxychloroquine to a person, without requiring a prescription order from a licensed health care practitioner, HCS SS SCS SB 878 14 upon the approval of a warning label for the use and indication in accordance with any written, standardized procedures or protocols for the pharmacist issued by the board of pharmacy, including, if required, providing the person with instructions on the proper use of ivermectin and hydroxychloroquine.

Any ivermectin or hydroxychloroquine that is dispensed by a pharmacist without a prescription shall be kept behind the counter or otherwise not available for self-service or direct consumer access, be stored in a secure area accessible only to pharmacy personnel, and be dispensed only by a pharmacist or pharmacy technician under a pharmacist's supervision.

SS SCS SB 878 10 (2) "Disaster period", the period of time that begins ten days before a governor's proclamation of a state of emergency or the declaration by the President of the United States of a major disaster or emergency, whichever occurs first, and extending for a period of sixty calendar days following the end of the period specified in the proclamation or declaration or sixty calendar days from the proclamation or declaration if no end is provided.

(3) "Nonprofit"Pharmacy", pharmacy",the anysame pharmacymeaning licensedgiven into this state that operates as a charitable organization under Section 501(c)(3) of the Internalterm Revenuein Codesection of338.210. 1986, as amended.

Notwithstanding any provision of law to the contrary, the board of pharmacy shall have the authority to waive HCS SS SCS SB 878 15 compliance with any Missouri rules and regulations for pharmaciesa licensed pharmacy that is domiciled or headquartered in this state when such nonprofit pharmacy is dispensing, shipping, or delivering prescription drugs into another state or United States territory that is experiencing a declared state disaster or emergency, provided that:

(1) The nonprofit pharmacy is a licensed pharmacy in good standing under this chapter and is authorized to ship prescription drugs into the state or territory in question;

(2) The nonprofit pharmacy is responding to an active declared state disaster or emergency;

(3) The nonprofit pharmacy complies with all emergency rules and regulations for pharmacies and nonprofit pharmacies established by the state or territory for the duration of the disaster period;

(4) The nonprofit pharmacy complies with all applicable federal laws and regulations;

and SS SCS SB 878 11 (5) The waiver applies only to prescription drugs dispensed, shipped, or delivered to residents or health care facilities located within the geographic area specified in the declared state disaster or emergency.

This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of HCS SS SCS SB 878 16 rulemaking authority and any rule proposed or adopted after August 28, 2026, shall be invalid and void.

376.417.

1.

As used in this section, the following terms mean:

(1) "340B drug", the same meaning given to the term in section 376.414;

(2) "Covered entity", any entity described in subparagraphs (A) to (K) of subsection (a)(4) of Section 340B of the Public Health Service Act, 42 U.S.C.

Section 256b, including any pharmacy with which such entity has contracted to dispense 340B drugs on behalf of the entity;

(3) "Health carrier", the same meaning given to the term in section 376.1350;

(4) "Pharmacy", an entity licensed under chapter 338;

(5) "Pharmacy benefits manager", the same meaning given to the term in section 376.388.

2.

A health carrier, a pharmacy benefits manager, or an agent or affiliate of such health carrier or pharmacy benefits manager shall not discriminate against a covered entity including, but not limited to, by doing any of the following:

(1) Reimbursing a covered entity for a quantity of a 340B drug in an amount less than it would pay any other similarly situated pharmacy or entity that is not a covered entity for such quantity of such drug on the basis that the covered entity is a covered entity or that the covered entity dispenses 340B drugs.

The director of the department of commerce and insurance shall specify by rule the circumstances under which a pharmacy or entity shall be deemed a "similarly situated pharmacy or entity" for purposes of this subdivision;

HCS SS SCS SB 878 17 (2) Imposing any terms or conditions on covered entities that differ from such terms or conditions applied to other similarly situated entities or pharmacies that are not covered entities on the basis that the covered entity is a covered entity or that the covered entity dispenses 340B drugs including, but not limited to, terms or conditions with respect to any of the following:

(a) Fees, chargebacks, clawbacks, adjustments, or other assessments;

(b) Professional dispensing fees;

(c) Restrictions or requirements regarding participation in standard or preferred pharmacy networks;

(d) Requirements relating to the frequency or scope of audits or to inventory management systems using generally accepted accounting principles;

and (e) Any other restrictions, conditions, practices, or policies that, as specified by the director of the department of commerce and insurance, interfere with the ability of a covered entity to maximize the value of discounts provided under 42 U.S.C.

Section 256b;

(3) Discriminating in reimbursement to a covered entity based on the determination or indication a drug is a 340B drug;

(4) Requiring a covered entity to identify, either directly or through a third party, a 340B drug;

(5) Refusing to cover drugs purchased under the 340B drug-pricing program;

or (6) Requiring a covered entity to reverse, resubmit, or clarify a 340B drug-pricing claim after the initial adjudication unless these actions are:

(a) In the normal course of pharmacy business and not related to 340B drug pricing;

or HCS SS SCS SB 878 18 (b) Required by federal law.

3.

The director of the department of commerce and insurance shall impose a civil penalty on any health carrier, pharmacy benefits manager, or agent or affiliate of such health carrier or pharmacy benefits manager that violates the requirements of this section.

Such penalty shall not exceed five thousand dollars per violation per day.

4.

The director of the department of commerce and insurance shall promulgate rules to implement the provisions of this section.

Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028.

376.1280.

1.

As used in this section, the following terms mean:

(1) "Acute pain", pain that results from disease, accidental or intentional trauma, or other causes, that a health care provider reasonably expects to last thirty days or fewer;

(2) "Chronic pain", pain that is a persistent and long- lasting condition characterized by discomfort or pain that lasts for more than twelve weeks, often persisting beyond the expected healing time.

It may result from various HCS SS SCS SB 878 19 causes including, but not limited to, injury, surgery, nerve damage, or underlying medical conditions;

(3) "Enrollee", the same meaning given to the term in section 376.1350;

(4) "Health benefit plan", the same meaning given to the term in section 376.1350;

(5) "Health care professional", the same meaning given to the term in section 376.1350.

2.

Notwithstanding any provision of law to the contrary, when a licensed health care professional acting within the scope of his or her license prescribes a nonopioid medication for the treatment of acute or chronic pain to an enrollee, it shall be unlawful for a health benefit plan to:

(1) Deny coverage of the nonopioid prescription drug in favor of an opioid prescription drug;

(2) Require the enrollee to try an opioid prescription drug before providing coverage of the nonopioid prescription drug;

or (3) Require a higher level of cost-sharing for the nonopioid prescription drug than for an opioid prescription drug.

3.

This section shall apply to health benefit plans delivered, issued for delivery, continued, or renewed on or after January 1, 2027.

4.

The provisions of this section related to the treatment of acute pain shall be applicable only when multiple nonopioid medications are approved by the U.S.

Food and Drug Administration and indicated for the treatment of acute pain.

5.

The provisions of this section related to the treatment of chronic pain shall be applicable only when HCS SS SCS SB 878 20 multiple nonopioid medications are approved by the U.S.

Food and Drug Administration and indicated for the treatment of chronic pain.

376.1960.

1.

This section shall be known and may be cited as "Nora's Law".

2.

As used in this section, the following terms mean:

(1) "Health benefit plan", the same meaning given to the term in section 376.1350;

(2) "Home blood pressure monitoring device", a mobile device that can be used to measure blood pressure, and that is validated for clinical accuracy and device calibration;

(3) "Home blood pressure monitoring device services", patient education and training services on the setup and use of a home blood pressure monitoring device.

3.

Health benefit plans delivered, issued for delivery, continued or renewed in this state on or after January 1, 2027, and providing for maternity benefits, shall provide coverage for a prescribed home blood pressure monitoring device and home blood pressure monitoring device services for pregnant women or women within twelve months postpartum when determined to be medically appropriate in accordance with American College of Obstetricians and Gynecologists guidelines.

Home blood pressure monitoring devices or home blood pressure monitoring device services prescribed shall meet the requirements for medical necessity only and can only be prescribed again if the condition being monitored deteriorates as to necessitate another prescription, or as necessary for subsequent pregnancies.

579.060.

1.

A person commits the offense of unlawful sale, distribution, or purchase of over-the-counter methamphetamine precursor drugs if he or she knowingly:

HCS SS SCS SB 878 21 (1) Sells, distributes, dispenses, or otherwise provides any number of packages of any drug product containing detectable amounts of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts, optical isomers, or salts of optical isomers, in a total amount greater than seven and two-tenths grams to the same individual within a thirty-day period, unless the amount is dispensed, sold, or distributed pursuant to a valid prescription;

or (2) Purchases, receives, or otherwise acquires within a thirty-day period any number of packages of any drug product containing any detectable amount of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts or optical isomers, or salts of optical isomers in a total amount greater than seven and two-tenths grams, without regard to the number of transactions, unless the amount is purchased, received, or acquired pursuant to a valid prescription;

or (3) Purchases, receives, or otherwise acquires within a twenty-four-hour period any number of packages of any drug product containing any detectable amount of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts or optical isomers, or salts of optical isomers in a total amount greater than three and six-tenths grams, without regard to the number of transactions, unless the amount is purchased, received, or acquired pursuant to a valid prescription;

or (4) Sells, distributes, dispenses, or otherwise provides any number of packages of any drug product containing detectable amounts of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts, optical isomers, or salts of optical isomers, in a HCS SS SCS SB 878 22 total amount greater than [forty-three] sixty-one and two- tenths grams to the same individual within a twelve-month period, unless the amount is dispensed, sold, or distributed pursuant to a valid prescription;

or (5) Purchases, receives, or otherwise acquires within a twelve-month period any number of packages of any drug product containing any detectable amount of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts or optical isomers, or salts of optical isomers in a total amount greater than [forty-three] sixty-one and two- tenths grams, without regard to the number of transactions, unless the amount is purchased, received, or acquired pursuant to a valid prescription;

or (6) Dispenses or offers drug products that are not excluded from Schedule V in subsection 17 or 18 of section 195.017 and that contain detectable amounts of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts, optical isomers, or salts of optical isomers, without ensuring that such products are located behind a pharmacy counter where the public is not permitted and that such products are dispensed by a registered pharmacist or pharmacy technician under subsection 11 of section 195.017;

or (7) Holds a retail sales license issued under chapter 144 and knowingly sells or dispenses packages that do not conform to the packaging requirements of section 195.418.

2.

A pharmacist, intern pharmacist, or registered pharmacy technician commits the offense of unlawful sale, distribution, or purchase of over-the-counter methamphetamine precursor drugs if he or she knowingly:

(1) Sells, distributes, dispenses, or otherwise provides any number of packages of any drug product HCS SS SCS SB 878 23 containing detectable amounts of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts or optical isomers, or salts of optical isomers, in a total amount greater than three and six-tenth grams to the same individual within a twenty-four hour period, unless the amount is dispensed, sold, or distributed pursuant to a valid prescription;

or (2) Fails to submit information under subsection 13 of section 195.017 and subsection 6 of section 195.417 about the sales of any compound, mixture, or preparation of products containing detectable amounts of ephedrine, phenylpropanolamine, or pseudoephedrine, or any of their salts, optical isomers, or salts of optical isomers, in accordance with transmission methods and frequency established by the department of health and senior services;

or (3) Fails to implement and maintain an electronic log, as required by subsection 12 of section 195.017, of each transaction involving any detectable quantity of pseudoephedrine, its salts, isomers, or salts of optical isomers or ephedrine, its salts, optical isomers, or salts of optical isomers;

or (4) Sells, distributes, dispenses or otherwise provides to an individual under eighteen years of age without a valid prescription any number of packages of any drug product containing any detectable quantity of pseudoephedrine, its salts, isomers, or salts of optical isomers, or ephedrine, its salts or optical isomers, or salts of optical isomers.

3.

Any person who violates the packaging requirements of section 195.418 and is considered the general owner or operator of the outlet where ephedrine, pseudoephedrine, or HCS SS SCS SB 878 24 phenylpropanolamine products are available for sale shall not be penalized if he or she documents that an employee training program was in place to provide the employee who made the unlawful retail sale with information on the state and federal regulations regarding ephedrine, pseudoephedrine, or phenylpropanolamine.

4.

A manufacturer commits the offense of unlawful sale, distribution, or purchase of over-the-counter methamphetamine precursor drugs if he or she knowingly fails to pay the fees required under subsection 7 of section 195.417.

5.

The offense of unlawful sale, distribution, or purchase of over-the-counter methamphetamine precursor drugs is a class A misdemeanor.