ARC 8420C

ARC 8420C

Proposing rulemaking related to definitions and licenses, registrations, and permits
and providing an opportunity for public comment

Following the publication of the Regulatory Analysis relating to this proposed rulemaking, modifications made to the rules included the addition of a fee table for quick reference, the clarification that a closing pharmacy will provide notice to patients who have received pharmacy services within the previous 18 months and that communication may be via electronic communication, the inclusion of updated Iowa Administrative Code references, the removal of language that is duplicated in other DIAL rules, and the addition of language relating to the submission of change applications for pharmacies to match the language for other business entities.

A Regulatory Analysis for this rulemaking was published in the Iowa Administrative Bulletin on August 7, 2024. A public hearing was held on the following date(s):

●August 29, 2024

Any persons who intend to attend a public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Board and advise of specific needs.

ITEM 1.Adopt the following new481—Chapter 550:

CHAPTER 550

DEFINITIONS

481—550.1(124,147,155A,272C) Definitions. For the purposes of 481—Chapter 550 through Chapter 557, and in addition to the definitions found in Iowa Code sections 124.101 and 155A.3, the following definitions apply:

“3PL” means third-party logistics.

“ACPE” means the Accreditation Council for Pharmacy Education.

“AMDS” means an automated medication dispensing system.

“Board” means the board of pharmacy.

“Certified pharmacy technician” or “certified technician” means an individual who holds a valid current national certification and who has registered with the board as a certified pharmacy technician.

“CFR” means the United States Code of Federal Regulations.

“CGMP” means current good manufacturing practices.

“Change of ownership” occurs when the owner listed on the pharmacy’s most recent application changes.

“Continuing education” means a structured educational activity that is applicable to the practice of pharmacy, that promotes problem solving and critical thinking, and that is designed or intended to support the continuing development of pharmacists while maintaining and enhancing their competence in the practice of pharmacy.

“CSA” means the Iowa controlled substances Act.

“DEA” means the United States Drug Enforcement Administration.

“DSCSA” means the federal Drug Supply Chain Security Act, Part II of the Drug Quality and Security Act, as codified in 21 U.S.C. §360eee-1 and 360eee-2 as created November 27, 2013.

“EMS program” means an emergency medical services program that is licensed with the bureau of emergency and trauma services.

“FDA” means the United States Food and Drug Administration.

“FPGEC” means the Foreign Pharmacy Graduate Examination Committee.

“NABP” means the National Association of Boards of Pharmacy.

“NAPLEX” means the North American Pharmacist Licensure Examination.

“National pharmacy technician certification” means documentation of the successful completion of a program and examination, including renewal, for the certification of pharmacy technicians that is accredited by the National Commission for Certifying Agencies.

“NCDQS” means the National Coalition for Drug Quality and Security.

“NDC” means National Drug Code.

“Office use” means the utilization of a compounded preparation from an outsourcing facility for direct patient administration by a health care practitioner in the normal course of professional practice or for dispensing by a health care practitioner or a pharmacy pursuant to a patient-specific prescription for patient self-administration.

“PMP” means the Iowa prescription monitoring program.

“Preceptor” means an Iowa-licensed pharmacist in good standing.

“U.S.C.” means the United States Code.

“USP” means the United States Pharmacopoeia.

This rule is intended to implement Iowa Code sections 124.302, 147.76 and 147.80 and chapters 155A and 272C.

ITEM 2.Adopt the following new481—Chapter 551:

CHAPTER 551

LICENSES, REGISTRATIONS, AND PERMITS

481—551.1(124,147,155A,272C) Definitions. The definitions found in 481—Chapter 550 are incorporated by reference into these rules.

481—551.2(124,124B,147,155A,272C) General requirements.

551.2(1) Issuance. The board will issue or renew a license, registration or permit upon receipt of a completed application and determination that the applicant has satisfied the requirements of applicable statutes and any additional criteria specified by these rules. A license or registration is necessary prior to engaging in the authorized activity into, out of, or within this state. A permit is necessary prior to engaging in the authorized activity in this state. Except as provided in these rules, the expiration date for any newly issued license, registration or permit will be extended by one year when the initial license, registration or permit is issued within two months of the standard expiration date.

551.2(2) Board forms. Initial applications, renewal applications, and other forms used for licensure, registration, or other purposes will be on board forms unless specified in these rules.

551.2(3) Fees.

a.Fees are nonrefundable and nontransferable and will be considered a repayment receipt as defined in Iowa Code section 8.2.

b.Fees apply to applications submitted for initial, changed and renewed licenses, registrations or permits or for a criminal history background check, when applicable.

c.A license, registration or permit will be invalidated when the method of payment is returned or rejected.

551.2(4) Fee table.

551.2(5) Criminal history background check. The fee for a criminal history background check is $45 and, in accordance with Iowa Code section 155A.40, is necessary for:

a.Pharmacists.

b.Outsourcing facility supervising pharmacists, except as provided in subparagraph
551.14(2)“a”(1).

c.Wholesale distributor and 3PL facility managers, except as provided in paragraphs
551.13(3)“a” and 551.16(3)“a.”

551.2(6) Separate locations. Each separate business location wherein activities occur that require a license, registration or permit will be separately licensed, registered or permitted.

551.2(7) Complete applications. An application is considered complete when all application information and fees are submitted to the board.

551.2(8) Incomplete applications. Applications that remain incomplete after six months from the date of initial board receipt will expire, except that applications for pharmacist licensure will expire:

a.After one year for an application for license transfer.

b.After two years for an application for license by examination or score transfer.

551.2(9) Inspections.

a.Prior to the issuance of a new license, registration or permit for any business that will maintain prescription drugs or for any individual CSA registrant who will maintain controlled substances, an inspection will be required, except as provided for limited distributors pursuant to subrule 551.15(1).

b.Any CSA registrant that does not maintain stocks of controlled substances will provide notice to the board at least 30 days prior to procuring controlled substances, and an inspection will be required prior to storage of controlled substances at the registered location.

551.2(10) Denial of license, registration or permit.

a.Grounds for denial. The board or authorized delegate may deny the issuance or renewal of a license, registration or permit for:

(1)Any violation of the laws of this state, another state, or the United States by the applicant relating to prescription drugs, controlled substances, or nonprescription drugs or for a violation of any rule of the board.

(2)The receipt of a certificate of noncompliance from child support services of the department of health and human services or the centralized collection unit of the department of revenue.

(3)The furnishing of false or fraudulent information in the application process.

(4)Noncompliance with licensing or practice standards under previously granted licenses, registrations or permits.

(5)Any other factors or qualifications the board considers relevant to and consistent with public health and safety.

b.Appeal of denial. An individual whose application is denied may, within 30 days after issuance of the notice of denial, appeal to the board for reconsideration of the application.

551.2(11) Renewals. Renewal applications will be submitted to the board in accordance with Iowa Code section 147.10.

551.2(12) Untimely renewals or change applications. Any licensee, registrant or permittee that fails to timely apply for renewal or change is provided a 30-day grace period to submit an application. The applicant may continue engaging in the authorized activity while the application is pending. Untimely applications will be subject to a late penalty fee that is equal to the application fee.

551.2(13) Expired licenses, registrations or permits—reactivation. Any licensee, registrant or permittee that fails to apply for renewal or change within the 30-day grace period may not engage in the authorized activity until the license, registration or permit is reactivated. An application will be subject to a fee of four times the application fee, except as provided herein.

a.A reactivation fee will not be assessed when the applicant voluntarily canceled the license, registration or permit when the applicant discontinued the authorized activity.

b.The reactivation fee for a wholesale distributor or 3PL provider license is $2,000.

c.The reactivation fee for a pharmacist license is $630.

d.The reactivation fee for a limited distributor license is $500.

e.The reactivation fee for a precursor substances permit is $360.

551.2(14) Termination of licenses, registrations or permits.

a.A business license, registration or permit will terminate when the business ceases to legally exist or discontinues business.

b.An individual license or registration will automatically terminate upon the death of the individual or upon the issuance of a superseding license or registration (e.g., issuance of a pharmacist license will result in the termination of the individual’s intern registration).

c.When a license or registration was issued by the board based on an underlying license, certificate or other credential and the underlying license, certificate or credential expires or is suspended or revoked, the board may take action to suspend or revoke the license or registration. Board action will not be taken against a pharmacist license issued by license transfer when the pharmacist’s original license upon which license transfer was granted expires.

551.2(15) Voluntary cancellations.

a.Businesses and CSA registrants who stock controlled substances.

(1)A licensee, registrant or permittee may voluntarily request cancellation via written notice to the board at least 30 days prior to the discontinuation of business. The notice will include the following information: the licensee, registrant or permittee name and address; the license, registration or permit number; the anticipated date of business discontinuation; and, if applicable, the identification of the licensee, registrant or permittee to whom drugs and records will be transferred. A canceled license, registration or permit is not subject to expired status or reactivation requirements.

(2)A business that has dispensed or distributed prescription or nonprescription products in the previous 18 months will provide written notice, which may include electronic communication, to its customers at least 30 days prior to the discontinuation of business that will include the anticipated date of business discontinuation and the identification of the licensee, registrant or permittee to whom the customers’ records will be transferred.

b.Individuals. An individual licensee or registrant may voluntarily request cancellation via written notice to the board. Except as provided herein for pharmacists, a licensee or registrant who requests voluntary cancellation is not subject to expired status or reactivation requirements. A pharmacist who voluntarily surrenders a license is subject to the reinstatement requirements pursuant to 481—Chapter 506.

551.2(16) Grounds for discipline. In addition to the grounds for discipline identified in 481—Chapter 504, the board may take disciplinary action against a license or registration for the following:

a.Distribution of drugs for other than lawful purposes, which includes but is not limited to the distribution of counterfeit drugs and the disposition of drugs in violation of Iowa Code chapters 124, 126, and 155A.

b.Obtaining, diverting, possessing, or attempting to obtain or possess prescription drugs without lawful authority, including but not limited to forging or altering a prescription for personal use or for distribution.

c.Practicing pharmacy, or assisting in the practice of pharmacy, while under the influence of alcohol, illicit substances, or prescription drugs or substances for which the licensee does not have a lawful prescription or while impaired by the use of legitimately prescribed prescription drugs.

d.Noncompliance with a child support order or with a written agreement for payment of child support as evidenced by a certificate of noncompliance issued pursuant to Iowa Code chapter 252J.

551.2(17) Agency rules adopted by reference. The board adopts by reference the following agency rules:

a.Military service, veteran reciprocity, and spouses of active-duty service members as found in 481—Chapter 7.

b.Contested cases and informal settlement as found in 481—Chapter 506.

c.Discipline as found in 481—Chapter 504.

d.Licensing and child support noncompliance, student loan repayment noncompliance, and nonpayment of state debt as found in 481—Chapter 8.

e.Use of criminal convictions in eligibility determinations and initial licensing decisions as found in 481—Chapter 502.

481—551.3(124,124B,147,155A,272C) Notifications to the board.

551.3(1) Criminal convictions and pleas. Within 30 days of adjudication, any conviction of or entry of a plea of guilty, nolo contendere, or no contest to a crime, other than a minor traffic offense, including if the judgment of conviction or sentence is deferred, will be reported to the board. Notification will include an unredacted copy of the final order of judgment. The notification requirement applies to:

a.An individual licensee or registrant.

b.A business licensee, registrant or permittee or any owner, supervising pharmacist or facility manager when the conviction is related to the practice of pharmacy or the distribution of drugs.

551.3(2) Disciplinary action. Any disciplinary action in another state or federal jurisdiction of a licensee, registrant or permittee or an owner, supervising pharmacist or facility manager of a license, registration or permit relating to the practice of pharmacy or the distribution of drugs will be reported to the board within 30 days of adjudication. Notification will include an unredacted copy of the action or order. Disciplinary action includes but is not limited to citations; reprimands; fines; restrictions; probation; or surrender, suspension or revocation of the license, registration, or permit.

551.3(3) Individual licensee or registration changes. Within 30 days of a change to the following, the licensee or registrant will provide the updated information to the board via written notice or via the board’s online licensing database:

a.Address.

b.Email address.

c.Telephone number.

d.Pharmacy of employment, if applicable.

e.Name, of which a written notice will include evidence of the legal name change.

481—551.4(147,155A,272C) Pharmacists.

551.4(1) License by examination or score transfer. An applicant for licensure by examination or score transfer will satisfy the requirements of Iowa Code sections 155A.8 and 155A.9 and do the following:

a.Graduate from an ACPE-accredited college of pharmacy within the United States, or, if a graduate of a foreign college of pharmacy, submit FPGEC certification and preceptor affidavit(s) of satisfactory completion of internship in accordance with subrule 551.6(3).

b.Pass the following examinations:

(1)NAPLEX. NAPLEX score transfers are accepted for one year from the date of the examination.

(2)A board-approved jurisprudence examination.

551.4(2) License transfer—general requirements. An applicant is eligible for license transfer when the applicant:

a.Holds a current and unencumbered license in a state or territory of the United States; and

b.Passes a board-approved jurisprudence examination.

551.4(3) License fee and duration. The license fee is $180, and the license will expire on June 30 two years after initial licensure.

551.4(4) Renewal standard.

a.Continuing education. Except for the first renewal following licensure by examination, a pharmacist will complete at least 30 hours of continuing education (CE) since the date of issuance or last renewal of the license, except as provided by Iowa Code section 272C.2(2)“h,” as a condition for license renewal. The type of CE completed shall be sufficient to meet the standard of care for the pharmacist’s specific practice setting and be provided by an accredited CE provider. The following will be deemed compliant with the CE hours:

(1)Active-duty military personnel serving honorably during the renewal period.

(2)Nonresident pharmacists who are actively licensed in the state in which they live and who do not practice in Iowa.

b.Child and dependent adult abuse training. A pharmacist who, in the course of employment or professional practice, examines, attends, counsels, or treats a minor or dependent adult will provide evidence of completion of training relating to the identification and reporting of child abuse or dependent adult abuse in accordance with Iowa Code section 232.69(3)“b” or 235B.16(5)“b,” respectively.

481—551.5(155A) Nonresident pharmacists in charge. Unless currently licensed as a pharmacist in Iowa, the pharmacist in charge of an Iowa-licensed nonresident pharmacy will be registered.

551.5(1) Registration fee and duration. The registration fee is $75, and the registration will expire annually on December 31.

551.5(2) Change. Within 30 days of a change to the home state license or registration information or status, the registrant will provide written notice of the change to the board.

481—551.6(155A) Pharmacist-interns.

551.6(1) Registration required. Unless currently licensed as a pharmacist in Iowa, an individual completing an internship, fellowship, or residency experience will be registered.

551.6(2) Registration fee and duration. The registration fee is $30, and the registration will expire one year following graduation from a college of pharmacy, following completion of a residency or fellowship, upon withdrawal from a college of pharmacy, or upon pharmacist licensure in Iowa, whichever occurs first.

551.6(3) Internship credit. Credit for internship hours completed in Iowa will only be granted for the pharmacy practice experience completed under the supervision of a preceptor during the period the pharmacist-intern was registered. Internship hours will remain valid for application for licensure by examination or score transfer pursuant to rule 481—551.4(147,155A,272C) for three years from the earlier of the date of graduation from an ACPE-accredited college of pharmacy or the expiration of the pharmacist-intern registration.

481—551.7(155A) Pharmacy technicians. Prior to engaging in technical functions in an Iowa pharmacy, an individual will register pursuant to this rule.

551.7(1) Technician trainee. An individual who does not hold current and active national pharmacy technician certification will register as a technician trainee. The registration fee is $20, and the registration will expire one year after initial registration. When necessary due to exceptional circumstances, a technician trainee will be limited to one renewal.

551.7(2) Certified pharmacy technician. An individual who holds current and active national pharmacy technician certification will register as a technician. The registration fee is $20 per annum, and the registration will expire on the date that the technician’s national certification expires.

481—551.8(155A) Pharmacy support persons. The registration fee is $25, and the registration will expire the last day of the birth month the second year after initial registration.

481—551.9(124) CSA—individuals.

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(5), a registered prescriber will not be required to obtain a separate registration for each additional location where the prescriber prescribes or administers controlled substances but does not procure or maintain stocks of controlled substances under the prescriber’s registration.

551.9(3) Registration fee and duration.

a.Researchers. The registration fee is $90, and the registration will expire the last day of the month the second year after initial registration.

b.Practitioners. The registration fee is $45 per annum, and the registration will expire on the date that the practitioner’s Iowa professional license expires.

551.9(4) Exempt from registration. An individual practitioner who meets the conditions of 21 CFR §1301.22(c) amended to March 24, 1997, is exempt from registration.

551.9(5) Changes. Within 30 days of a change to the registered location or substances authorized, the registrant will provide the updated information to the board via written notice or via the board’s online licensing database.

481—551.10(124,155A) Pharmacies.

551.10(1) License types. Licensed pharmacy types include:

a.General pharmacy.

b.Hospital pharmacy.

c.Telepharmacy.

d.Limited-use pharmacy.

e.Nonresident pharmacy.

551.10(2) License fee and duration. The license fee is $135, and the license will expire annually on December 31.

551.10(3) Changes.

a.Written notice. Within 30 days of a change, except as provided herein, the pharmacy will provide the following updated information to the board via a board form.

(1)Pharmacist in charge, except that notification of a change of pharmacist in charge of a nonresident pharmacy will be submitted within ten days of the change.

(2)Ownership.

b.Application. A licensee will seek modification of the pharmacy license for the following changes via submission of a completed application and fee prior to the effective date of the change, except as provided herein. A resident licensee will submit the application at least 30 days prior to the anticipated change, and, except as provided, a nonresident licensee will submit the application within 30 days of the licensee’s receipt of an updated license from the home state regulatory authority, if applicable, reflecting the change.

(1)Name.

(2)Location, except for a temporary relocation of limited duration due to an exceptional circumstance. An application will be submitted at least 30 days prior to the anticipated relocation.

(3)License type. An application will be submitted at least 30 days prior to the anticipated change.

481—551.11(124) CSA—businesses.

551.11(1) Registration for independent activities. A separate registration will be necessary for each separate independent activity as provided in 21 CFR §1301.13 amended to April 11, 2022.

551.11(2) Separate registrations for separate locations.

a.A separate registration will be necessary for each location where controlled substances are manufactured, distributed, imported, exported, dispensed, stored, or collected for the purpose of disposal unless exempt from registration pursuant to Iowa Code section 124.302(2) or as provided in 21 CFR §1301.12 amended to February 28, 2024.

b.A separate registration for a pharmacy will not be required when providing an emergency kit of limited drug quantities to an entity authorized to administer such emergency drugs, such as a care facility or EMS program.

551.11(3) Registration fee, duration, and exemptions.

a.The registration fee is $45 per annum and will expire on the second-last day of the month following initial registration, except that the expiration may be aligned with the entity’s underlying business license, if applicable.

b.The registration fee is waived for federal, state, and local law enforcement agencies and the following federal and state institutions: hospitals; health care or teaching institutions; and analytical laboratories authorized to possess, manufacture, distribute, and dispense controlled substances in the course of official duties.

551.11(4) Changes.

a.Written notification. Within 30 days of a change to the following, the registrant will provide the updated information to the board via a board form or via the board’s online licensing database:

(1)Substances authorized.

(2)Responsible individual, except as required in subparagraph 551.11(4)“b”(2).

(3)Ownership.

b.Application. A CSA—business registrant will seek modification of the registration for the following changes via submission of an application and fee within 30 days of the change, except as provided herein:

(1) Location. For an in-state registrant, an application will be submitted at least 30 days prior to the change of location.

(2)Responsible individual for outsourcing facilities, 3PL providers, and wholesale distributors.

(3)Name.

481—551.12(124B) Precursor substances.

551.12(1) Permit fee and duration. The permit fee is $180, and the permit will expire annually on December 31.

551.12(2) Exemptions. A permit is not required for the distribution of exempt chemical mixtures or for transactions deemed excluded by 21 CFR Part 1310 as amended on October 31, 2023.

481—551.13(155A) Wholesale distributors.

551.13(1) License standards.

a.To be eligible for licensure as a wholesale distributor, each application will include evidence of:

(1)Surety bond or equivalent security pursuant to the DSCSA.

(2)Current drug distributor accreditation by NABP, NCDQS, or another accreditation body approved by the board. New applicants located in Iowa that undergo an opening inspection will not be obligated to provide evidence of accreditation for initial licensure.

b.In the event the requirements in paragraph 551.13(1)“a” directly conflict with any federal law or regulation, the federal law or regulation will supersede the requirements in paragraph 551.13(1)“a.”

551.13(2) License fee and duration. The license fee is $750, and the license will expire annually on December 31.

551.13(3) License changes.

a.Written notice. A licensee will provide written notice to the board within 30 days of:

(1)The designation of a temporary facility manager who will not be subject to a criminal history background check.

(2)A change of business type.

(3)A change of ownership.

b.Application. A licensee will seek modification of the license for the following changes via submission of an application and fee. A resident licensee will submit the application at least 30 days prior to the anticipated change, and, except as provided, a nonresident licensee will submit the application within 30 days of the licensee’s receipt of an updated license from the home state regulatory authority, if applicable, reflecting the change.

(1)Name.

(2)Location.

(3)Permanent facility manager. A licensee will submit an application within 30 days of the identification of a new permanent facility manager and within 90 days of the initial vacancy.

481—551.14(155A) Outsourcing facilities.

551.14(1) License fee and duration. The license fee is $400, and the license will expire annually on December 31.

551.14(2) License changes.

a.Written notice. A licensee will provide written notice to the board via a board form within 30 days of:

(1)The designation of a temporary supervising pharmacist who will not be subject to a criminal history background check.

(2)A change of ownership.

b.Application. A licensee will seek modification of the license for the following changes via submission of an application and fee. Except as provided herein, a resident licensee will submit the application at least 30 days prior to the anticipated change and a nonresident licensee will submit the application within 30 days of the change to the FDA registration or home state license, if applicable, reflecting the change.

(1)Name.

(2)Location.

(3)Permanent supervising pharmacist. A licensee will submit an application identifying the new permanent supervising pharmacist within 30 days of the identification of the permanent supervising pharmacist and within 90 days of the initial vacancy.

481—551.15(155A) Limited distributors.

551.15(1) Self-inspection. Each application for a limited distributor license will include a completed self-inspection.

551.15(2) License fee and duration. The license fee is $175, and the license will expire annually on December 31.

551.15(3) License changes.

a.Written notice. The licensee will provide written notice within 30 days of a change of:

(1)Facility manager.

(2)Business type.

(3)Ownership.

b.Application. Modification of the license for the following changes will be pursuant to the submission of an application and fee at least 30 days prior to the change, except as provided herein, for a resident licensee and within 30 days of the change to the home state license for a nonresident licensee, if applicable, reflecting the change.

(1)Name.

(2)Location.

481—551.16(155A) Third-party logistics providers.

551.16(1) License standards.

a.To be eligible for licensure, each application will include evidence of current drug distributor accreditation by NABP, NCDQS, or another accreditation body approved by the board. New applicants located in Iowa that undergo an opening inspection will not be obligated to provide evidence of accreditation for initial licensure.

b.In the event the requirements in this subrule directly conflict with any federal law or regulation, the federal law or regulation will supersede the requirements herein.

551.16(2) License fee and duration. The license fee is $750, and the license will expire annually on March 31.

551.16(3) License changes.

a.Written notice. A licensee will provide written notice to the board within 30 days of:

(1)The designation of a temporary facility manager who will not be subject to a criminal history background check.

(2)A change of ownership.

b.Application. A licensee will seek modification of the license for the following changes via submission of an application and fee. A resident licensee will submit the application at least 30 days prior to the anticipated change, and, except as provided, a nonresident licensee will submit the application within 30 days of the licensee’s receipt of an updated license from the home state regulatory authority, if applicable, reflecting the change.

(1)Name.

(2)Location.

(3)Permanent facility manager. A licensee will submit an application within 30 days of the identification of a new permanent facility manager and within 90 days of the initial vacancy.

These rules are intended to implement Iowa Code sections 124.302, 147.76 and 147.80 and chapters 155A and 272C.