Iowa Administrative Code

551.9(1) Registration for independent activities. A separate registration will be necessary for each separate independent activity as provided in 21 CFR §1301.13 as amended on April 11, 2022. 551.9(2) Registration for separate locations—exemption. Notwithstanding subrule 551.2(6)…

reference into these rules. [ARC 9338C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter]

verification program in accordance with this rule for the purpose of redirecting pharmacist time to clinical services. 552.10(1) Policies and procedures. A pharmacy will establish policies and procedures prior to initiation of a program that will include but not be limited to: a.…

contrary to public interest include but are not limited to: 552.11(1) Unethical conduct that includes but is not limited to fraud, misrepresentation, negligence, concealment, negating the patient’s freedom of choice for pharmacy services, or breaching the public trust with respec…

552.12(1) Legitimate purpose. Prescriptions will be valid when issued for a legitimate medical purpose by a prescriber acting in the usual course of the prescriber’s professional practice to a patient within an established prescriber/patient relationship, except when issued in ac…

552.13(1) Exemptions. In addition to the exemptions identified in Iowa Code sections 124.308 and 155A.27, the following prescriptions will be exempt from the electronic transmission requirement: a. A prescription issued pursuant to Iowa Code section 280.16A. b. A prescription iss…

552.14(1) Required elements. Each medication order for a hospital patient or for a noncontrolled substance for a care facility or correctional facility patient will include: a. Patient name. b. Drug name, strength, and dosage form. c. Instructions for use. d. Date of authorizatio…

552.15(1) Prior to dispensing. Except for prescriptions issued in accordance with Iowa Code section 135.185, 135.190, 139A.41, 147A.18, or 280.16A, a pharmacist will perform a drug utilization review for each prescription dispensed. 552.15(2) Prior to second administration from s…

patient or the patient’s caregiver. Individuals authorized to transfer prescriptions include a pharmacist and, except for transfers of controlled substance prescriptions, a certified pharmacy technician and a pharmacist- intern. 552.16(1) Limitations. Transfers of controlled subs…

the entities or through common ownership, utilize the services of another Iowa-licensed pharmacy for prescription processing, filling, or dispensing when: 552.17(1) The entities involved have real-time electronic access to the prescription in process that is secure from unauthori…

552.18(1) Managing pharmacy requirement. Only an Iowa-licensed and Iowa-located pharmacy can serve as a managing pharmacy for a telepharmacy site located in Iowa. 552.18(2) Agreement. An agreement between a telepharmacy and a managing pharmacy will include: a. The services to be …

552.19(1) The packaging is appropriate for the medication. 552.19(2) The packaging can be appropriately labeled in accordance with rule 481—552.21(155A). 552.19(3) An assigned beyond-use date is appropriate for the medication and packaging used. 552.19(4) Medications that were co…

552.2(1) Standards. Each pharmacy will maintain: a. Adequate drug storage areas to ensure that drug products are maintained under sanitary conditions and in accordance with package labeling standards. b. References and drug information as needed to meet the needs of the patients …

552.20(1) Stocking AMDS. Drug products will be loaded into an AMDS or component via barcode scanning by pharmacy personnel, except pharmacy support persons, as delegated by the supervising pharmacist. 552.20(2) Pharmacist verification of AMDS-dispensed drugs. a. Prepackaged medic…

552.21(1) Ambulatory prescription labeling. The required labeling elements for a prescription dispensed for an ambulatory patient include: a. Patient name, except as provided by the Iowa Code. b. Prescriber name. c. Pharmacy name, address, and telephone number. d. Product name, s…

552.22(1) USP standards—pharmacies. Preparations compounded pursuant to 21 U.S.C. §353a (Food, Drug, and Cosmetic Act §503A) as amended November 27, 2013, will be prepared in accordance with the standards of USP General Chapter 795 (2023) for nonsterile compounds and USP General …

552.23(1) Counseling required. Except for institutionalized patients, prior to dispensing a prescription that is a new or changed therapy, a pharmacist or pharmacist-intern will counsel the patient or the patient’s caregiver on matters that, in the pharmacist’s professional judgm…

to facilities licensed and authorized to administer medications to patients pursuant to established policies and procedures, ensuring that the drugs are stored in a location that is secure from unauthorized access and maintains product integrity. Each emergency kit will be labele…

quality improvement or similar program to timely detect, identify, evaluate and prevent medication errors. 552.25(1) Reportable program events. Medication errors resulting in the incorrect dispensing of a prescribed drug received by or administered to a patient that require docum…

pharmacist may, pursuant to statewide protocols developed by the board in consultation with the department of health and human services and available on the board’s website at dial.iowa.gov, order and dispense medications pursuant to the requirements identified in the statewide p…

552.27(1) Agreement. A pharmacist or pharmacy may engage in collaborative pharmacy practice under a collaborative pharmacy practice agreement with one or more practitioners who are authorized to independently prescribe, or as established by a health system pharmacy and therapeuti…

section 155A.47, a pharmacy may submit a pilot or demonstration research project (“pilot project”) to the board for approval. 552.28(1) Petition. A petition for a pilot project, including for renewal of a previously approved project, will include: a. The name, email address, and …

552.29(1) Personnel and training. a. An authorized nuclear pharmacist will meet all applicable requirements of the United States Nuclear Regulatory Commission pursuant to 10 CFR (2023). b. Notwithstanding rule 481—552.9(155A), pharmacy personnel registered as a pharmacy support p…

552.3(1) Physical security. Each pharmacy will maintain adequate security to ensure the confidentiality of patient information and to prevent theft of, diversion of, or unauthorized access to prescription drugs or records, including when prescription drugs or records are stored o…

552.30(1) Types of records. Each pharmacy will maintain the following records, if applicable to the pharmacy’s operation: a. Patient records, including demographic information, prescription or medication order information and all information needed to conduct drug utilization rev…

552.4(1) Pharmacy personnel. Each pharmacy will employ personnel who: a. Are licensed or registered pursuant to 481—Chapter 551. b. Have documented training or education for the activities within their scope of practice. 552.4(2) Identification. When the pharmacy is open to the p…

care within the individual’s scope of practice that would be provided in a similar setting by a reasonable and prudent licensee or registrant with similar education, training and experience. [ARC 9338C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter]

or direction of a court, except where the best interests of the patient require, pharmacy personnel will not divulge or reveal to any person other than the patient or the patient’s authorized representative, the prescriber or other licensed practitioner then caring for the patien…

practice experience that, at a minimum, includes community, institutional and clinical pharmacy practice settings that are licensed in the state in which they are located. A student who has been awarded a pharmacy degree from an ACPE-accredited college of pharmacy located in the …

552.8(1) Temporary absence of pharmacist. a. Pharmacist is not on site. Pharmacy policies and procedures may designate pharmacy personnel who may be present in the pharmacy department to perform delegated functions in accordance with subrule 552.3(3), with the exception of dispen…

552.9(1) Technicians and pharmacy support persons. A supervising pharmacist may delegate any nonclinical function to a pharmacy technician or pharmacy support person in accordance with the individual’s registration, training, and education. 552.9(2) Pharmacist-interns. A precepto…

reference into these rules. [ARC 9339C, IAB 6/11/25, effective 7/16/25; see Delay note at end of chapter]

553.10(1) Changes prohibited. The following elements may not be added or changed on a Schedule II controlled substance prescription: a. The patient’s name. b. The substance prescribed, except for generic substitution. c. The prescriber’s name or signature. 553.10(2) Changes autho…

21 U.S.C. §830 as amended on October 17, 2000, 21 CFR Part 1314, and Iowa Code section 124.212A, registrants will record the retail sales of scheduled listed chemical products. If the real-time electronic pseudoephedrine tracking system (PTS) is unavailable for use, the purchase …

by a court or released by the governor’s office of drug control policy (office) pursuant to state or federal law. Information may not be released except as provided herein. 553.12(1) PTS administrators. PTS administrator access to PTS database information will be pursuant only to…

553.13(1) For cannabis-derived products, the board will modify the schedule of controlled substances in accordance with Iowa Code section 124.201A. 553.13(2) Amend Iowa Code section 124.204(2) by adding the following new paragraphs: cq. 2-methyl-N-(1-phenethylpiperidin-4-yl)-N-ph…

553.14(1) Excluded nonnarcotic products. The board hereby excludes from all schedules the current list of excluded nonnarcotic products identified in 21 CFR §1308.22. 553.14(2) Exempt substances. With the exception of listed butalbital products, the board hereby excludes from all…

loss of precursor substances will be in accordance with the requirements identified in Iowa Code chapter 124B and this rule. 553.15(1) Receipt from out-of-state source. A report of the receipt of a precursor substance from a source outside the state will be submitted no more than…

553.16(1) Face-to-face transactions. In addition to the elements identified in Iowa Code section 124B.3(2)“c,” a letter of authorization will include: a. The name of the purchaser’s representative authorized to receive the substance. b. The signature of the purchaser’s representa…

553.2(1) Federal regulations. Registrants will comply with applicable federal laws and regulations relating to controlled substances, scheduled listed chemical products, and listed chemicals. 21 CFR Chapter 2 as amended on September 19, 2023, is incorporated herein by reference. …

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…