Iowa Administrative Code

procedures to guard against theft and diversion of controlled and precursor substances and records. Physical security controls will be commensurate with the schedules and quantities of such substances in the possession of the registrant or permittee in normal business operation a…

at a minimum: 553.4(1) Adequate storage to ensure security and proper storage conditions in accordance with product package labeling. 553.4(2) Access to controlled substances and records by employees of the registrant. 553.4(3) Proper disposition of controlled substances. 553.4(4…

found in 21 CFR §1301.52 and 21 CFR §1304.11, each registrant will document a physical count of all on- hand stocks of controlled substances in accordance with 21 CFR §1304.11, except as provided herein. 553.5(1) Exact quantities. Each inventory will include the exact count or me…

accountability of all controlled substances under their control in accordance with this rule. 553.6(1) Perpetual inventory. Each registrant will maintain a perpetual inventory that accurately reflects the on-hand inventory of all Schedule II substances at all times. A perpetual i…

notification requirements found in 21 CFR §1301.74 and 21 CFR §1301.76, registrants will submit notice and reports of theft or significant loss as determined by the factors provided in 21 CFR §1301.76(b) amended June 22, 2023, of controlled substances as provided herein. 553.7(1)…

553.8(1) Destruction. Registrants will maintain documentation of disposal of controlled substances pursuant to 21 CFR §1317.05 and 21 CFR §1317.95. 553.8(2) Administration waste. Registrants will document disposal of controlled substance administration waste pursuant to 21 CFR §1…

elements identified in Iowa Code sections 124.308 and 155A.27 and 21 CFR Parts 1306 and 1311, a prescription is based upon a valid prescriber-patient relationship. Once the prescriber-patient relationship is broken and the prescriber is no longer available to treat the patient or…

reference into these rules. [ARC 9340C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter]

554.2(1) Distribution of finished drug products. Licensees will comply with applicable federal laws and regulations relating to the distribution of products as defined in 21 U.S.C. §360eee. 21 U.S.C. Chapter 9, Subchapter V, Part H, as enacted November 27, 2013, is incorporated h…

policies and procedures that address, at a minimum: 554.3(1) Receipt, security, storage, inventory, and distribution of prescription drugs and devices, including for drugs and devices supplied to a salesperson or representative or dispensed pursuant to patient- specific prescript…

554.4(1) Retention. All records relating to distribution will be maintained at the licensed location for at least two years from the date of the record or entry to the record. 554.4(2) Accessibility. Electronic records will be capable of producing a hard-copy printout of transact…

554.5(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations. 554.5(2) Have adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions. 554.5(3) Except for returns processors, have a qua…

554.6(1) Preparation standards. Compounded preparations will be prepared in accordance with the standards of CGMP in accordance with 21 CFR Part 210 as amended on December 10, 2009, and Part 211 as amended on November 18, 2016. 554.6(2) Labeling standards. Labels for compounded p…

554.7(1) Examination of materials. Limited distributors will ensure, upon receipt and prior to distribution, that a drug or device is suitable for distribution. 554.7(2) Verification. Orders will be verified, prior to distribution, to ensure that the drug or device being distribu…

reference into these rules. [ARC 9341C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter]

intends to administer controlled substances in or into Iowa will obtain a controlled substances Act registration in accordance with rule 481—551.11(124). The registration will secondarily identify the medical director or pharmacy that owns the controlled substances used at the EM…

555.3(1) A log of EMS program personnel who have access to prescription drugs and records will be maintained and include personnel name, unique identification used in program records, and level of certification. 555.3(2) EMS program personnel who are authorized to access replenis…

medical director or pharmacy that owns the drugs used at the EMS program, establish and follow policies and procedures for the handling and utilization of prescription drugs and the storage and security of program and drug records. [ARC 9341C, IAB 6/11/25, effective 7/16/25; see …

555.5(1) Environmental standards. Prescription drugs in the EMS program will be stored in a manner that ensures the drugs are maintained within the environmental requirements provided in the drug labeling. Storage temperatures will be monitored and documented to prevent and detec…

555.6(1) Prescription drugs will not be administered beyond the labeled expiration date and, no later than the expiration date, will be removed from EMS program stock. 555.6(2) Prescription drugs subject to a product recall will be removed from EMS program stock. 555.6(3) Prescri…

555.7(1) The unused portion of a controlled substance resulting from patient administration may be destroyed by the administering EMS program personnel, the medical director, or a pharmacist pursuant to EMS program policies and procedures. 555.7(2) Documentation of the administra…

drugs used in the EMS program will ensure the completion and documentation of a monthly inspection of all such drugs maintained at the EMS program and any program substation. Inspection will include the removal of outdated or adulterated drugs. If the drugs are owned by the medic…

maintained for at least two years from the date of the record or the last date of employment for personnel records and will be available for inspection and copying by the board or its authorized agent. [ARC 9341C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter] …

reference into these rules. [ARC 9342C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter]

556.2(1) Membership. The members of the PMP advisory committee will include prescribing practitioners as identified in Iowa Code section 124.555(1) and may include a multidisciplinary coalition of authorized users who routinely interact with the PMP and one member of the public w…

556.3(1) Registration. Authorized access to PMP information pursuant to Iowa Code section 124.553 will be available only to registered users, except as provided herein. 556.3(2) Registration not needed. Individuals seeking their own individual prescription records need not regist…

556.4(1) Reportable data. The following will be reported to the PMP in accordance with Iowa Code sections 124.551, 124.552, and 124.554(1)“g”: a. Controlled substances dispensed to a patient for self-administration. b. Opioid antagonists dispensed or administered by a practitione…

556.5(1) Board. The board will collect, store, and disseminate program information using technology that utilizes encryption as defined in Iowa Code section 715C.1. 556.5(2) Integrated systems. A practitioner, pharmacy, or health care system utilizing an integrated system to conn…

556.6(1) Patient requests. An individual patient or a patient’s authorized representative may request the patient’s own prescription history report via submission of a completed PMP patient request form via personal, mail, or commercial delivery. A patient’s authorized representa…

557.1(1) Authority. The board’s authority for regulating the practice of pharmacy and the legal distribution and dispensing of prescription drugs and devices, including controlled substances, in the state of Iowa is found in Iowa Code chapters 124, 124B, 126, 147, 155A, 205 and 2…

department of inspections and appeals to issue citations and assess penalties for violations of the statutes or departmental rules relating to the health care facilities, the following rules indicate the method by which citations may be issued when a particular statute or departm…

56.10(1) The director of the department of inspections and appeals may consider evidence of the circumstances surrounding the violation including, but not limited to, those factors set out in rule 481— 56.9(135C) when: a. Determining whether a violation will be subject to a fine …

inspections and appeals may issue a citation for a class I violation when a physical condition or one or more practices exist in a facility which are not in violation of a specific statute or rule, but which constitute an imminent danger or a substantial probability of resultant …

department of inspections and appeals may issue a citation for a class I violation when a physical condition or one or more practices exist in a facility which are a result of multiple lesser violations of the statutes or rules, but which taken as a whole constitute an imminent d…

and appeals shall contain the following information: 56.13(1) A description of the nature of the violation; 56.13(2) A statement of the Code section or subsection or the rule or standard violated. (In the case of class I violations as described in 481—56.11(135C), a statement of …

the facility shall respond in the following manner, according to the type of citation issued. 56.14(1) If the facility does not desire to seek an informal conference or contest the citation, the facility shall remit to the department of inspections and appeals the amount specifie…

informal dispute resolution held pursuant to 42 CFR Section 488.331 for those health care facilities certified under Medicare or the medical assistance program. 56.15(1) Definition. For purposes of these rules, “independent reviewer” means an attorney licensed in the state of Iow…

conference requested by the licensee and provided pursuant to 56.14(3): 56.16(1) If the facility does not desire to further contest an affirmed or modified citation for a class I, class II or class III violation, the facility shall, within five business days after the informal co…

17A, and the rules adopted by the department of inspections and appeals shall be followed in all cases where proper notice has been made to the department of inspections and appeals of the intent to formally contest any citation. These rules are intended to implement Iowa Code ch…

statutes or departmental rules which may result in the issuance of a citation by the director of inspections and appeals and the assessment of a penalty therefor. 56.2(1) Class I. A class I violation is one which presents an imminent danger or a substantial probability of resulta…

appeals for violations of the statutes or rules relating to health care facilities will subject the facility to the following penalties. 56.3(1) Citation for a class I violation. The penalty shall not be less than $2,000 nor more than $10,000. The penalty for a class I violation …

inspections and appeals for violations of the statutes or rules related to health care facilities shall specify the length of time permitted for the violation to be abated or eliminated, as follows: 56.4(1) Citation for a class I violation: The violation shall be abated or elimin…

any class of violation within the time specified in the citation, unless the licensee shows that the failure was due to circumstances beyond the licensee’s control, shall subject the facility to a further penalty of $50 for each day that the violation continues after the time spe…

56.6(1) Treble fines for repeated violations. The director of the department of inspections and appeals shall treble the penalties specified in rule 481—56.3(135C) for any second or subsequent class I or class II violation occurring within any 12-month period, if a citation was i…

those which are informational in character, shall be followed by a notation at the end of each rule, or pertinent part thereof. This notation shall consist of a Roman numeral or numerals in parentheses. These Roman numerals refer to the class (either class I, class II, or class I…

rule, or part of a rule is followed by a notation consisting of more than one Roman numeral in parentheses, at the discretion of the director of the department of inspections and appeals, the director may issue a citation for a violation of that rule, or part thereof, designating…

violation will be designated in the citation, where more than one class is specified in the notation following the rule, the director of the department of inspections and appeals shall consider evidence of the circumstances surrounding the violation, including, but not limited to…

definitions set out in Iowa Code section 135C.1 shall be considered to be incorporated verbatim in these rules. “Accommodation” means the provision of lodging, including sleeping, dining, and living areas. “Activities of daily living” means the following self-care tasks: bathing,…

approved by the department or acting in a provisional capacity in accordance with these rules. (III) 57.10(1) Qualifications of an administrator. a. The administrator shall be at least 21 years of age and shall have a high school diploma or equivalent. (III) In addition, this per…

57.11(1) Alcohol and drug use prohibited. No person under the influence of intoxicating drugs or alcoholic beverages shall be permitted to provide services in a residential care facility. (I, II) 57.11(2) Job description. There shall be a written job description developed for eac…