Rules of Department of Commerce and Insurance Division 2150—State Board of Registration for the Healing Arts Chapter 5—General Rules Title Page 20 CSR 2150-5.020 Nonpharmacy Dispensing ................................................................3 20 CSR 2150-5.025 Administration of Vaccines Per Protocol...............................................3 20 CSR 2150-5.026 General Provisions.........................................................................5 20 CSR 2150-5.028 Medication Therapy Services By Protocol ............................................5 20 CSR 2150-5.029 Pharmacist Authority to Prescribe Pursuant to Section 338.665 ..................8 20 CSR 2150-5.030 Physical Therapy, Rehabilitation Services, or Both ..................................8 20 CSR 2150-5.100 Collaborative Practice Arrangement with Nurses ....................................9 JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 1 Secretary of State Chapter 5—General Rules 20 CSR 2150-5 Title 20—DEPARTMENT OF (D) The physician’s name and address; and (A) Vaccines must be administered in accor- COMMERCE AND INSURANCE (E) The exact name and strength of the dance with current treatment guidelines estab- Division 2150—State Board of drug dispensed and, in the case of a generic lished by the Centers for Disease Control Registration for the Healing Arts drug, the name of the manufacturer or (CDC) and the manufacturer’s guidelines, Chapter 5—General Rules repackager of the drug. It shall be a violation provided CDC guidelines shall control in the of this rule for a physician to dispense a event of a conflict. Vaccines may not be 20 CSR 2150-5.020 Nonpharmacy Dispens- generic drug and affix to the label any trade administered to persons under seven (7) years ing name or other identification that would serve of age unless otherwise authorized by law. to misrepresent the source of the drug. (B) Pharmacists shall ensure compliance PURPOSE: This rule provides information with all state and federal laws and regulations (5) Physicians may dispense only to individu- concerning the general responsibilities of a pertaining to Vaccine Information Statements als with whom they have established a physi- and informed consent requirements. physician who elects to dispense medications cian/patient relationship. It shall be a viola- from his/her office or clinic. (C) Vaccines must be stored in accordance tion of this rule for a physician to dispense with CDC guidelines/recommendations and medication at the order of any other physician (1) Physicians must provide patients the free- within the manufacturer’s labeled require- not registered to practice at that same loca- ments, including, when vaccinating outside of dom of choice concerning the source of drugs tion. and devices prescribed during the course of a pharmacy. (D) A pharmacist may only delegate vac- the physician/patient relationship. This (6) It is not the intention of this rule to inter- cine administration to an intern pharmacist or means that no physician may require, as a fere with any recognized system for physician qualified pharmacy technician who has met condition of the physician/patient relation- education operated by any accredited medical school located within the borders of Missouri the qualifications of subsections (3)(B) and ship, that the patient only receive drugs dis- (C) of this rule and is working under the pensed directly from the physician’s office. nor is it the intention of this rule to interfere with the individual physician’s appropriate direct supervision of a pharmacist qualified By the same token, a physician cannot require use of professional samples nor is it the inten- to administer vaccines. Proof of an intern’s or any patient to use the services of any particu- tion of this rule to interfere in any way with qualified pharmacy technician’s compliance lar pharmacy. the physician’s right to directly administer with subsections (3)(B) and (C) must be drugs or medicines to any patient. maintained by both the supervising pharma- (2) Physicians must provide appropriate cist and the intern pharmacist/qualifying supervision to personnel employed to assist in (7) Whenever dispensing takes place, appro- pharmacy technician for a minimum of two the dispensing of drugs and devices from the priate records shall be maintained. These (2) years. physician’s office. records must be adequate to show the name (E) For purposes of this rule, a “qualified (A) When the dispensing personnel is of the patient, the name and strength of the pharmacy technician” is defined as a current- either a licensed physician assistant acting drug dispensed, the quantity, the dose, etc. A ly registered Missouri pharmacy technician within the scope of a supervision agreement separate log must be maintained for con- who— or licensed nurse acting within the scope of a trolled substance dispensing. 1. Holds an active pharmacy technician collaborative practice arrangement, the physi- certification issued by a certification entity cian is not required to be present. AUTHORITY: section 334.125, RSMo 2000.* accredited by the National Commission for (B) In all other instances, it shall be a vio- This rule originally filed as 4 CSR 150-5.020. Certifying Agencies; Original rule filed May 11, 1984, effective lation of this rule for any physician to permit 2. Has an initial and, if applicable, Sept. 14, 1984. Moved to 20 CSR 2150- the dispensing of medication from his/her annual documented assessment of competen- 5.020, effective Aug. 28, 2006. Amended: clinic or office when that physician is not pre- cy in vaccine administration; and Filed Aug. 14, 2009, effective Jan. 30, 2010. sent unless another physician duly licensed 3. Has assisted in the practice of phar- macy as a registered/licensed pharmacy tech- under the provisions of Chapter 334, RSMo, *Original authority: 334.125, RSMo 1959, amended is present. 1993, 1995. nician in the state of Missouri or another U.S. state or territory for a minimum of one (3) Physicians who elect to dispense medica- (1) year. tion must comply with the regulations gov- 20 CSR 2150-5.025 Administration of Vac- (2) The authorizing physician is responsible erning the types of container that may be used cines Per Protocol for the oversight of, and accepts responsibili- to repackage prescription drugs as specified PURPOSE: This rule establishes the proce- ty for, the vaccines administered by the phar- by federal law or rule unless the individual to dures for pharmacists to administer vaccines macist. whom the drug is dispensed gives written per written protocol with a physician. authorization for the container to be other- (3) Pharmacist Qualifications. Pharmacists wise. (1) A pharmacist may administer vaccines administering vaccines by protocol as autho- authorized by Chapter 338, RSMo, pursuant rized by Chapter 338, RSMo, must first file (4) All drugs dispensed by a physician shall to a written protocol with a Missouri licensed a Notification of Intent (NOI) to administer bear a label permanently affixed to the exte- physician who is actively engaged in the prac- vaccines with the Missouri Board of Pharma- rior of the drug container which sets forth the tice of medicine. Unless otherwise restricted cy. To file a NOI, a pharmacist must— following information: by the governing protocol, vaccines may be (A) Hold a current Missouri pharmacist (A) The date; administered at any Missouri licensed phar- license; (B) The patient’s name; macy or at any non-pharmacy location as (B) Hold a current healthcare provider (C) Complete directions for usage; allowed in the governing protocol. level cardiopulmonary resuscitation (CPR) or JOHN R. ASHCROFT (6/30/21) CODE OF STATE REGULATIONS 3 Secretary of State 20 CSR 2150-5—DEPARTMENT OF COMMERCE AND INSURANCE Division 2150—State Board of Registration for the Healing Arts basic life support (BLS) certification issued 9. Procedures for disposing of used and 1. If the vaccine is administered on by the American Heart Association, the contaminated supplies; behalf of a pharmacy, both the pharmacy and American Red Cross, or an equivalent orga- 10. Authorization to administer vaccines the administering pharmacist shall ensure the nization. The qualifying BLS or CPR certifi- at a non-pharmacy location, if applicable; records required by subsection (5)(A) are cation program must have included a live in- 11. Record-keeping requirements and any promptly delivered to and maintained at the person skills assessment; and required notification procedures; and pharmacy separate from the pharmacy’s pre- (C) Have successfully completed a certifi- 12. A provision allowing termination of scription files; cate program in administering vaccines the protocol at any time at the request of any 2. If the vaccine is not administered on accredited by the Accreditation Council for party. behalf of a pharmacy, records must be main- Pharmacy Education (ACPE), provided by an (B) The protocol, and any subsequent tained by the administering or supervising ACPE, or regionally accredited pharmacy or amendments or alterations, must be reviewed pharmacist at an address identified in the pro- medical school/college or approved by the and manually or electronically signed and tocol prior to administering the vaccine; Board of Pharmacy. The required certificate dated by the pharmacist and authorizing 3. Prescription records must be main- program must include a live/in-person train- physician prior to its implementation, signi- tained as required by Chapter 338, RSMo, ing component and include instruction in: fying that both are aware of its contents and and the rules of the board; and 1. Current CDC guidelines and recom- agree to follow the terms of the protocol. A 4. Records required by this rule must be mendations for vaccines authorized by Chap- copy of the protocol must be maintained by maintained for two (2) years and made avail- ter 338, RSMo, including, recommended both the pharmacist and the authorizing able for inspecting and copying by the State immunization schedules; physician for a minimum of eight (8) years Board of Pharmacy or the State Board of Reg- 2.