reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.10 - Ownership of Prescription Drugs

Current through Register Vol. 47, No. 3, July 24, 2024
All prescription drugs obtained for use in a service program
				shall be owned either by a pharmacy or by the medical director of the service
				program.
(1)
Pharmacy-based
			 service programs.
If the drugs are owned by a pharmacy or more than
			 one pharmacy pursuant to these rules, the service program shall be considered a
			 pharmacy-based service program and shall comply with these rules as they
			 pertain to a pharmacy-based service program.
(2)
Medical director-based service
			 programs.
If the drugs are owned by the medical director, the service
			 program shall be considered a medical director-based service program and shall
			 comply with these rules as they pertain to a medical director-based service
			 program.
(3)
Combination
			 pharmacy-based and medical director-based service programs.
If the
			 service program has entered into both pharmacy-based and medical director-based
			 service program agreements, both the pharmacy and the medical director shall
			 retain separate ownership of the prescription drugs supplied and shall comply
			 with these rules as applicable. The primary program site shall maintain a list
			 that identifies which prescription drugs are owned and supplied by each
			 responsible individual.
(4)
Transfer of ownership.
Any transfer of ownership of
			 prescription drugs and devices in a service program shall be in compliance with
			 657-Chapter 10, 657-Chapter 17, and federal laws and regulations.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.11 - Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The
			 service director, the medical director, and the responsible individual shall
			 develop, implement, and adhere to written policies and procedures for the
			 operation and management of the service program with respect to prescription
			 drugs and devices in accordance with these rules. These policies and procedures
			 shall be available for inspection and copying by the board, its representative,
			 or any other authorized individual. The policies and procedures shall be
			 periodically reviewed by the responsible individual, the medical director, and
			 the service director and shall identify the frequency of the review.
			 Documentation of the review shall be maintained.
(2) The policies and procedures shall
			 address, at a minimum, the following:
a.
			 Storage of drugs at the primary program site and any program substations,
			 including appropriate temperature controls , temperature monitoring and
			 response when drugs are exposed to extreme temperatures pursuant to rule
			 657-11.13
			 (124,147A,155A).
b. Storage of
			 drugs at the primary program site and any program substations, including
			 adequate security to prevent diversion and unauthorized access to drugs and
			 records pursuant to rule 657-11.13(124,147A,155A).
c. Protocols for administration of drugs
			 pursuant to rule 657-11.14(124,147A,155A).
d. Administration of drugs outside the parameters of written
			 protocols pursuant to rule
			 657-11.15
			 (124,147A,155A).
e. Service program
			 personnel matters including, but not limited to:
(1) Access to prescription drugs and records, identifying level of
			 access based upon employee certification level and scope of practice.
(2) Authority to administer drugs based upon
			 employee certification level and scope of practice.
(3) Authority to order, receive, and
			 distribute prescription drugs and devices.
(4) Initial training and periodic review of the medication
			 policies and procedures.
(5)
			 Identification of registered nurses not employed by the service program who are
			 authorized by the medical director pursuant to Iowa Code section
			 147A.12
			 and pursuant to rules of the board of nursing to provide emergency care under
			 the service program's protocol.
f. Process for the return of drugs pursuant to rule
			 657-11.22
			 (124,147A,155A).
g. Out-of-date
			 and adulterated drugs pursuant to rule
			 657-11.23
			 (124,147A,155A).
h. Drug and device
			 recalls pursuant to rule 657-11.24(124,147A,155A).
i. Monthly inspections pursuant to rule
			 657-11.20
			 (124,147A,155A).
j. Record
			 retention as described in rule 657-11.34(124,147A,155A) and other applicable
			 rules of the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.13 - Storage

Current through Register Vol. 47, No. 3, July 24, 2024
Prescription drugs at primary program sites and program
				substations shall be stored in designated secure areas that are clean and free
				of debris, where temperature is appropriately controlled, and in a manner to
				protect identity and integrity.
(1)
Temperature.
Each drug shall be stored within the temperature
			 range required in the manufacturer labeling. The service program shall utilize
			 a method to provide continuous temperature control or monitoring, such as a
			 temperature indicator, which at a minimum identifies when the drugs have been
			 exposed to extreme temperatures. The service program shall regularly, but at
			 least weekly, verify and document verification that the drugs have not been
			 exposed to extreme temperatures. Drugs that are subjected to extreme
			 temperatures shall not be administered to patients and shall be quarantined and
			 returned to the responsible individual for disposition. Extreme temperatures
			 shall be defined as excessive heat greater than 40 degrees Celsius (104 degrees
			 Fahrenheit) and, if the product requires protection from freezing temperatures,
			 excessive cold less than -10 degrees Celsius (13 degrees Fahrenheit).
			 Disposition of unusable drugs shall be in compliance with rule
			 657-11.32(124,147A,155A).
(2)
Security.
The security of prescription drugs, records for such
			 drugs, and patient records is the responsibility of the responsible individual
			 and shall provide for the effective control against theft of, diversion of, or
			 unauthorized access to drugs and records. Policies shall identify procedures
			 that will utilize or require the signature of two service employees for each
			 disbursement to ensure accountability for controlled substances.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.14 - Protocols

Current through Register Vol. 47, No. 3, July 24, 2024
Every service program shall utilize department protocols as the
				standard of care. The service program medical director may authorize an
				alternative protocol provided the directives are within the EMS provider's
				scope of practice , are within acceptable medical practice, and have been filed
				with the department. Prescription drugs shall be administered pursuant only to
				a written protocol or oral order by an authorized prescriber. A copy of the
				current protocol shall be provided to and maintained by the responsible
				individual, the service director, the primary program site and each program
				substation and shall be available for inspection and copying by the board, its
				representative, or any other authorized individual.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.15 - Administration of Drugs Beyond the Limits of a Written Protocol

Current through Register Vol. 47, No. 3, July 24, 2024
Drugs may be administered beyond the limits of a written
				protocol provided that medical direction from an authorized prescriber has been
				obtained prior to administration. The authorization shall be recorded in the
				patient care report documenting the identity of the authorizing prescriber. If
				an agent of the authorized prescriber relayed the order, the identity of the
				prescriber's agent, including the agent's first and last names and title, shall
				also be recorded. The administration of a Schedule II controlled substance in a
				pharmacy-based service program shall be documented pursuant to rule
				657-11.16(124,147A,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.16 - Administration of Schedule Ii Controlled Substances-pharmacy-based Service Program

Current through Register Vol. 47, No. 3, July 24, 2024
In a pharmacy-based service program, Schedule II controlled
				substances may be administered to patients under the care of a service program,
				including administration beyond the limits of a protocol when authorized
				pursuant to rule
				657-11.15
				(124,147A,155A), provided that a signed order is delivered by the authorized
				prescriber to the pharmacy within seven days of the date administration was
				authorized. The signed order shall contain all of the prescription information
				required pursuant to Iowa Code section
				155A.27.
				The patient care report may be accepted as the required signed order if the
				patient care report includes the required prescription information, including
				an original signature of the authorizing prescriber.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.19 - Patient Care Reports

Current through Register Vol. 47, No. 3, July 24, 2024
Patient care reports shall be maintained at the primary program
				site or the program substation as required by the bureau and rule
				657-11.34
				(124,147A,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.22 - Return of Drugs

Current through Register Vol. 47, No. 3, July 24, 2024
Drugs that have been removed from service program stock shall
				be returned to the responsible individual. In a pharmacy-based service program,
				drugs returned from the service program to the pharmacy may be used by the
				pharmacy for subsequent dispensing or administration provided the drugs are not
				outdated or adulterated. Records of the return of prescription drugs shall be
				maintained by the responsible individual for two years from the date of the
				return.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.23 - Out-of-date Drugs or Devices

Current through Register Vol. 47, No. 3, July 24, 2024
Any drug or device bearing an expiration date shall not be
				administered beyond the expiration date of the drug or device. Outdated drugs
				or devices shall be removed from service program stock and quarantined until
				such drugs or devices are returned to the responsible individual for
				disposition.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.24 - Product Recall

Current through Register Vol. 47, No. 3, July 24, 2024
Each service program shall have a procedure for removal from
				service program stock all drugs or devices subject to a product recall. The
				procedure shall include action appropriate to the direction or requirements of
				the recall.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.26 - Controlled Substances Records

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Records maintained.
Every inventory or other record required to be maintained under this chapter,
			 657-Chapter 10, or Iowa Code chapter 124 shall be maintained at the primary
			 program site or the program substation and by the pharmacy if the service
			 program is pharmacy-based. All required records shall be available for
			 inspection and copying by the board, its representative, or any other
			 authorized individual for at least two years from the date of such record.
			 Controlled substances records shall be maintained in a readily retrievable
			 manner. Schedule II controlled substances records shall be maintained
			 separately from all other records of the registrant.
(2)
Receipt and disbursement records
			 in medical director-based service programs.
Any pharmacy or other
			 authorized registrant that provides controlled substances for a medical
			 director-based service program shall provide to the service program a record of
			 the disbursement and maintain a record of the disbursement pursuant to rule
			 657-10.16
			 (124). The service program shall retain the record on which an authorized
			 individual shall sign and record the actual date of receipt. The record shall
			 include the following:
a. The name of the
			 substance;
b. The strength and
			 dosage form of the substance;
c.
			 The number of units or commercial containers acquired from other registrants,
			 including the date of receipt and the name, address, and DEA registration
			 number of the registrant from whom the substances were acquired;
d. The number of units or commercial
			 containers distributed to other registrants, including the date of distribution
			 and the name, address, and DEA registration number of the registrant to whom
			 the substances were distributed; and
e. The number of units or commercial
			 containers disposed of in any other manner, including the date and manner of
			 disposal and the name, address, and DEA registration number of the registrant
			 to whom the substances were distributed for disposal, if appropriate.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.27 - Ordering Schedule Ii Controlled Substances-medical Director-based Service Programs

Current through Register Vol. 47, No. 3, July 24, 2024
Except as otherwise provided by 657-subrule 10.17(2) and under
				federal law, a DEA Form 222, preprinted with the address of the primary program
				site, is required to be maintained at the primary program site for the
				acquisition of each supply of a Schedule II controlled substance. The order
				form shall be executed only by the medical director named on the order form or
				by an authorized signer designated pursuant to a properly executed power of
				attorney. A DEA Form 222 shall be dated and signed as of the date the order is
				submitted for filling. A medical director or authorized signer shall not
				pre-sign a DEA Form 222 for subsequent completion. All Schedule II order forms
				shall be maintained at the primary program site and shall be available for
				inspection and copying by the board, its representative, or any other
				authorized individual for a period of two years from the date of the
				record.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.29 - Schedule Ii Controlled Substances Perpetual Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
Each service program located in Iowa that administers Schedule
				II controlled substances shall maintain a perpetual inventory for all Schedule
				II controlled substances pursuant to the requirements of this rule. All records
				relating to the perpetual inventory shall be maintained at the primary program
				site and shall be available for inspection and copying by the board, its
				representative, or any other authorized individual for a period of two years
				from the date of the record.
(1)
Record.
The perpetual inventory record may be maintained in a
			 hard-copy or electronic record format. Any electronic record shall provide for
			 hard-copy printout of all transactions recorded in the perpetual inventory
			 record for any specified period of time and shall state the current inventory
			 quantities of each drug at the time the record is printed. A record entry, once
			 recorded, shall not be changed; any adjustments or corrections shall require
			 entry of a separate record as provided in subrule 11.29(3).
(2)
Information included.
The perpetual inventory record shall identify all receipts and disbursements of
			 Schedule II controlled substances by drug name or by National Drug Code (NDC),
			 including each patient administration, wastage, and return of a drug to the
			 responsible individual. The record of receipt shall also identify the source of
			 the drug, the strength and dosage form, the quantity, the date of receipt, and
			 the name or unique identification of the individual verifying receipt of the
			 drug. The disbursement record shall identify where or to whom the drug is
			 disbursed or administered, the strength and dosage form, the quantity, the date
			 of disbursement or administration, and the name or unique identification of the
			 individual responsible for the disbursement. Receipts and disbursements shall
			 be recorded in the perpetual inventory as soon as practicable but no later than
			 24 hours after the receipt, disbursement, or administration.
(3)
Adjustments or corrections to the
			 record.
Any adjustments or corrections made to the perpetual inventory
			 shall include the identity of the person making the adjustment or correction
			 and the reason for the adjustment or correction.
(4)
Reconciliation.
The
			 pharmacist in charge or designee in a pharmacy-based service program, or the
			 medical director or designee in a medical director-based service program, shall
			 be responsible for reconciling the perpetual inventory record of all Schedule
			 II controlled substances with the physical inventory at least monthly. Any
			 discrepancy shall be reported within 24 hours of the discovery to the
			 responsible individual for investigation.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.30 - Controlled Substances Annual Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
An accurate inventory shall be taken annually of all controlled
				substances maintained at the primary program site and program substations.
				Controlled substances in a pharmacy-based service program shall be included in
				the pharmacy's annual controlled substances inventory. The inventory record
				shall identify the drug name or National Drug Code (NDC) and the exact quantity
				under the control of the service program including drugs in replenishment stock
				and quarantined stock. The inventory record shall contain the date and time the
				inventory was taken and the printed name and signature of the individual or
				individuals responsible for the inventory record. Records of the inventory
				shall be maintained pursuant to rule
				657-11.34(124,147A,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.32 - Disposition of Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
Disposition of controlled substances shall be pursuant to the
				requirements of this rule, rule
				657-11.29
				(124,147A,155A), 657-Chapter 10, and federal regulations. Records shall be
				maintained at the primary program site and, if the service program is
				pharmacy-based, records shall be maintained at the pharmacy.
(1)
Outdated, adulterated, or
			 unwanted supply.
Controlled substances shall not be destroyed except
			 as provided in subrule 11.32(2). Any drug that requires disposition shall be
			 quarantined until the drug can be returned to the responsible individual. The
			 responsible individual shall ensure the proper disposition of controlled
			 substances according to the following procedures:
a. The responsible individual shall utilize
			 the services of a DEA-registered and Iowa-licensed disposal firm (reverse
			 distributor), or
b. The responsible
			 individual shall utilize such other means determined and approved by the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.33 - Report of Loss or Theft of Controlled Substance

Current through Register Vol. 47, No. 3, July 24, 2024
Upon suspicion of any loss or theft of a controlled substance,
				the service director shall immediately notify the responsible individual. The
				responsible individual shall provide notice and reporting as required in rule
				657-10.21(124).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.34 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
If a service program includes a primary program site and one
				or more program substations, each record shall identify the specific location
				to which it applies. Records regarding service program substation activities,
				including drug supply and administration records, may be maintained at the
				primary program site but shall clearly identify the program substation to which
				the records apply. All records regarding prescription drugs and devices in a
				service program shall be maintained for two years from the date of the activity
				or record and be available for inspection and copying by the board, its
				representative, or any other authorized individual
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.1 - Precursor Substance Identified

Current through Register Vol. 47, No. 3, July 24, 2024
For the purpose of this chapter, precursor substance includes
				all substances identified in Iowa Code section
				124B.2. Additional precursor
				substances may be identified by listing in this rule.
(1) Amend Iowa Code section
			 124B.2(1)  by
			 adding the following new paragraphs:
ah.
			 Methyl alpha-phenylacetoacetate (other names: MAPA; methyl
			 3-oxo-2-phenylbutanoate) and its optical isomers.
ai. 1-boc-4-AP (tert-butyl
			 4-(phenylamino)piperidine-1-carboxylate) and its salts.
aj. 4-piperidone (piperidin-4-one), its
			 acetals, its amides, its carbamates, its salts, and salts of its acetals, its
			 amides, and its carbamates, and any combination thereof, whenever the existence
			 of such is possible.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.2 - Reports Required

Current through Register Vol. 47, No. 3, July 24, 2024
Except as provided in rule 12.4(124B) or 12.5(124B), the
				following reports shall be filed with the board on forms provided or approved
				by the board. Copies of reports submitted pursuant to this rule shall be
				maintained for two years following the date of the report.
(1)
Delivery in Iowa.
Any
			 manufacturer, retailer, or other person who sells, transfers, or otherwise
			 furnishes a precursor substance to anyone within this state shall report the
			 transaction to the board no less than 21 days prior to delivery of the
			 substance.
(2)
Receipt from
			 out-of-state source.
Any vendor, recipient, or other person who
			 receives a precursor substance from a source outside the state shall submit to
			 the board a report of the transaction no more than 14 days following receipt of
			 the substance.
(3)
Missing
			 quantity.
Any vendor, recipient, or other person who is authorized to
			 possess precursor substances in this state shall report to the board within
			 seven days of discovering either of the following occurrences:
a. Loss or theft of a precursor
			 substance.
b. A difference between
			 the amount of a precursor substance shipped and the amount of a precursor
			 substance received.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.3 - Form of Reports

Current through Register Vol. 47, No. 3, July 24, 2024
All reports shall be on forms provided by the board except as
				provided in rule 12.4(124B). The following minimum information shall be
				completed for each required report.
(1)
Delivery.
Each form that
			 reports the sale, transfer, or other furnishing of a precursor substance shall
			 contain the following information:
a. Name of
			 substance;
b. Quantity of
			 substance;
c. Date sold,
			 transferred, or furnished;
d. Name
			 and address of business or person selling, transferring, or furnishing the
			 substance;
e. The signature of the
			 person or the signature of an officer, authorized agent, or authorized employee
			 of the business selling, transferring, or furnishing the substance;
f. Name, address, and identification
			 information of the person or business purchasing or receiving the
			 substance.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.4 - Monthly Reporting Option

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Regular repeated deliveries.
Vendors who regularly transfer
			 the same precursor substance to the same recipient may apply to the board for
			 authorization to submit the report of those transactions on a monthly basis.
			 Requests for monthly reporting authorization must be received at the board
			 office at least 21 days prior to the board meeting at which the request will be
			 considered. The board will review each request to determine if the requirements
			 of Iowa Code chapter 124B are met and will notify the vendor of its decision
			 and the reporting format that will be authorized.
(2)
Computer-generated
			 reports.
Vendors may also petition the board to accept reports on a
			 computer-generated basis. If approved, reports may be furnished in hard copy or
			 in board-approved data storage format. The vendor will be responsible for the
			 accuracy of all reports and the prompt correction of any data entry or
			 transmission errors.
(3)
Authorization rescinded at board's discretion.
Authorization
			 to report monthly or to use computer-generated reporting may be rescinded at
			 the board's discretion and with 30 days' advance notice.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.5 - Exemptions

Current through Register Vol. 47, No. 3, July 24, 2024
The following are exempt from the reporting requirements of
				subrules 12.2(1), 12.2(2), 12.3(1), and 12.3(2) and the identification
				requirements of rule 12.6(124B):
1. A
			 licensed pharmacist or other person authorized under Iowa Code chapter 155A to
			 sell or furnish a precursor substance upon the prescription of a
			 practitioner.
2. A practitioner who
			 administers or furnishes a precursor substance to a patient.
3. A manufacturer, wholesaler, retailer, or
			 person who holds a permit issued by the board and who sells, transfers, or
			 otherwise furnishes a precursor substance to a practitioner or pharmacy as
			 defined in Iowa Code section
			 155A.3.
4. Any retailer or person who sells,
			 transfers, furnishes, or receives a drug containing ephedrine,
			 phenylpropanolamine, or pseudoephedrine or a cosmetic containing a precursor
			 substance if the drug or cosmetic is lawfully sold, transferred, or furnished
			 over the counter without a prescription in accordance with Iowa Code chapter
			 126.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.6 - Identification of Purchaser or Other Recipient

Current through Register Vol. 47, No. 3, July 24, 2024
Prior to selling, transferring, or otherwise furnishing in this
				state any precursor substance as defined in rule 12.1(124B), a vendor shall
				require appropriate identification of any purchaser or other recipient. Letters
				and other documentation required by this rule shall be maintained for two years
				following delivery.
(1)
Face-to-face transactions.
Prior to furnishing any precursor
			 substance in any face-to-face transaction, a vendor shall require and document
			 all of the following:
a. A valid driver's
			 license or other state-issued identification issued to the purchaser's
			 representative. The identification shall contain the photograph and residential
			 or mailing address, other than a post office box number, of the purchaser's
			 representative.
b. The motor
			 vehicle license number of the vehicle owned or operated by the purchaser or the
			 purchaser's representative.
c. A
			 letter of authorization from the purchaser. The letter shall include the
			 purchaser's business license number and business address, a description that
			 identifies how the substance will be used, the name of the purchaser's
			 representative authorized to receive the substance, and the purchaser's
			 signature. The purchaser's representative shall also sign the letter in the
			 presence of the vendor and the vendor shall sign as a witness to the
			 identification and signature of the purchaser's representative.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.7 - Permits

Current through Register Vol. 47, No. 3, July 24, 2024
Persons or entities in this state that purchase, transfer, or
				otherwise receive a precursor substance as defined in rule
				657-12.1
				(124B) from a source outside the state shall obtain a permit from the board. No
				person or entity required to obtain a permit shall receive a precursor
				substance from a source outside the state until an application for permit is
				approved and the board has issued a permit certificate. Permits shall expire on
				the last day of the calendar year in which the permit is issued.
(1)
Applications.
An
			 applicant shall submit a completed application and nonrefundable fee pursuant
			 to subrule 12.7(2).
a. Each application shall
			 include all requested information, unless the item is not applicable, in which
			 case that fact shall be indicated.
b. Each application, attachment, or other
			 document filed as part of an application shall be signed by the applicant as
			 follows:
(1) If the applicant is an
			 individual, signature shall be by that individual.
(2) If the applicant is a partnership,
			 signature shall be by a partner.
(3) If the applicant is a corporation,
			 corporate division, association, trust, or other entity, signature shall be by
			 the chief executive officer.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 12 - Precursor Substances › Rule 657-12.8 - Denial, Modification, Suspension, or Revocation of Permit

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to 657-Chapters 35 and 36, the board may deny,
				suspend, revoke, or modify any permit for any period of time it determines to
				be justified upon the facts of the case for any violation of this chapter or
				Iowa Code chapter 124B.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to provide standards for the
				provision of telepharmacy services to patients. These rules provide for
				pharmaceutical care services at a telepharmacy site utilizing audiovisual
				technologies that link the telepharmacy site with a managing pharmacy and one
				or more verifying pharmacists, but do not include remote pharmacist
				verification occurring in or on behalf of a hospital pharmacy. The telepharmacy
				site and the managing pharmacy shall be located within Iowa and shall maintain
				appropriate licensure by the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For purposes of this chapter, the following definitions shall
				apply:
"ACPE"
means the Accreditation Council for
				Pharmacy Education.
"Board"
means the board of pharmacy.
"CSA"
or
"CSA registration"
means a registration issued pursuant to Iowa Code section
				124.303 and
				657-Chapter 10.
"DEA"
means the Drug Enforcement
				Administration of the U.S. Department of Justice.
"Managing pharmacy"
means a licensed pharmacy
				located in Iowa that oversees the activities of one or more telepharmacy
				sites.
"Telepharmacy"
means the practice of pharmacy
				where pharmaceutical care services are provided using audiovisual technologies
				linking a telepharmacy site with the managing pharmacy.
"Telepharmacy personnel"
means one or more
				registered certified pharmacy technicians or registered pharmacy support
				persons who have met the general requirements for telepharmacy site practice
				and who work at a telepharmacy site under the remote supervision of a verifying
				pharmacist.
"Telepharmacy site"
means a licensed pharmacy
				that is operated by a managing pharmacy and staffed by telepharmacy personnel
				where pharmaceutical care services, including the storage and dispensing of
				prescription drugs, drug utilization review, and patient counseling, are
				provided by a licensed pharmacist through the use of technology.
"Verifying pharmacist"
means a remote
				Iowa-licensed pharmacist or pharmacists who perform any step in the
				prescription verification and dispensing process including but not limited to:
				verification of data entry; product selection, packaging, and labeling; drug
				utilization review; and patient counseling.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.3 - Written Agreement

Current through Register Vol. 47, No. 3, July 24, 2024
The managing pharmacy and the telepharmacy site shall execute
				and maintain a current written agreement between the pharmacies. If there is no
				current written agreement between the pharmacies, the telepharmacy site shall
				immediately notify the board and shall discontinue operations as a telepharmacy
				site until a current written agreement between the managing pharmacy and the
				telepharmacy site is executed.
(1)
Contents of agreement.
The written agreement between the
			 managing pharmacy and a telepharmacy site shall include, but may not be limited
			 to, the following:
a. Staffing, to include
			 telepharmacy personnel staffing, verifying pharmacist staffing and
			 availability, and on-site pharmacist staffing as needed.
b. Hours of operation of the telepharmacy
			 site and hours of availability of pharmacists at the managing
			 pharmacy.
c. Emergency contact
			 information for the managing pharmacy and the telepharmacy site.
d. A complete description of the audiovisual
			 technology to be utilized to link the managing pharmacy and the telepharmacy
			 site.
e. A provision that, in the
			 event that the telepharmacy personnel is not available at the telepharmacy
			 site, that a verifying pharmacist is not available, or that the audiovisual
			 communication connection between the telepharmacy site and the managing
			 pharmacy is not available, the telepharmacy site shall close pending the
			 availability of telepharmacy personnel, the verifying pharmacist, and the
			 communication link or pending the arrival at the telepharmacy site of a
			 pharmacist to provide on-site pharmacy services.
f. Activities and services to be provided by
			 the managing pharmacy at the telepharmacy site.
g. Identification of contact persons to
			 receive, on behalf of the managing pharmacy and the telepharmacy site,
			 notifications and official communications regarding the written agreement.
			 Identification of contact persons shall include delivery addresses and
			 preferred methods of delivery of the written communications required by this
			 rule and any other communications affecting the written agreement between the
			 managing pharmacy and the telepharmacy.
h. Pharmacy locations, other than the
			 managing pharmacy, where verifying pharmacists may be based or
			 located.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.8 - General Requirements for Telepharmacy Site

Current through Register Vol. 47, No. 3, July 24, 2024
In addition to applicable requirements for pharmacies located
				in Iowa, a telepharmacy site shall also ensure compliance with the requirements
				identified herein.
(1)
Security.
A telepharmacy site shall employ methods to prevent
			 unauthorized access to prescription drugs, devices, and pharmacy and patient
			 records. Such methods may include an alarm system and shall include other
			 security systems and methods as provided by these rules. Alarm systems and
			 entry system locks should be disarmed when the telepharmacy site is staffed and
			 open for business. Minimum security methods shall include:
a. Electronic keypad or other electronic
			 entry system into the telepharmacy site or the pharmacy department that
			 requires and records the unique identification of the individual accessing the
			 pharmacy, including the date and time of access. Complete access records shall
			 be maintained for a minimum of two years beyond the date of access.
b. Secure storage such as a safe.
c. Controlled access to computer
			 records.
d. A continuous system of
			 video surveillance and recording of the pharmacy department that includes
			 maintenance of recordings for a minimum of 60 days following the date of the
			 recording.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.10 - General Requirements for Verifying Pharmacist

Current through Register Vol. 47, No. 3, July 24, 2024
A verifying pharmacist shall maintain a current and active
				license to practice pharmacy in Iowa.
(1)
Location of verifying
			 pharmacist.
The verifying pharmacist who is performing patient
			 counseling shall be physically located within the managing pharmacy or another
			 pharmacy licensed to operate a pharmacy in Iowa.
(2)
Adequate audiovisual
			 connection.
The verifying pharmacist shall ensure adequate audiovisual
			 connection with the telepharmacy site during all periods when the pharmacist is
			 responsible for verifying telepharmacy site activities and practices, including
			 ensuring confidentiality of communications in compliance with state and federal
			 confidentiality laws.
(3)
Verifying pharmacist training.
A verifying pharmacist shall be
			 adequately trained on the use of the technology to ensure accurate verification
			 and patient counseling and shall review and understand the policies and
			 procedures of the managing pharmacy and the telepharmacy site.
(4)
Patient refusal of
			 counseling.
If a patient or patient's caregiver refuses patient
			 counseling, the refusal shall be directly communicated by the patient or
			 patient's caregiver to the pharmacist through audiovisual communication.
			 Telepharmacy personnel may not accept and communicate a refusal of patient
			 counseling from the patient or patient's caregiver to the pharmacist.
(5)
Reference library.
A
			 verifying pharmacist shall have access to all required references applicable to
			 the telepharmacy services provided at the telepharmacy site.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.11 - General Requirements for Telepharmacy Technician

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Registration and
			 certification.
A telepharmacy technician shall maintain current
			 national certification and registration in good standing with the board as a
			 certified pharmacy technician.
(2)
Practice experience.
Before practicing in a telepharmacy site,
			 a telepharmacy technician shall have completed a minimum of 2,000 hours of
			 practice experience as a certified pharmacy technician, at least 1,000 hours of
			 which shall be practicing in an Iowa-licensed pharmacy and 160 hours of which
			 shall be practicing in a managing pharmacy, at another pharmacy which uses the
			 same audiovisual technology system, or at the telepharmacy site under the
			 direct supervision of an on-site pharmacist. The board may establish a
			 committee to consider, on a case-by-case basis, requests for exceptions to the
			 practice experience requirements in exceptional circumstances that may
			 otherwise result in the closure of the telepharmacy site.
(3)
Training.
In addition to
			 training required of all pharmacy technicians, a telepharmacy technician shall
			 complete the following minimum training requirements before practicing in a
			 telepharmacy site. Records of telepharmacy technician training shall be
			 documented and maintained by the telepharmacy site.
a. Review and understanding of the policies
			 and procedures of the managing pharmacy.
b. Review and understanding of the policies
			 and procedures of the telepharmacy site.
c. Review and understanding of these rules
			 for telepharmacy practice.
d.
			 Review and understanding of pharmacy technician rules, 657-Chapter 3.
e. Understanding of the operation of the
			 audiovisual technologies to be utilized at both pharmacies.
f. Training at the telepharmacy site under
			 the direct supervision of an on-site verifying pharmacist. Training shall
			 include operation and use of the audiovisual technology and other means of
			 communication between the telepharmacy site and the managing pharmacy and all
			 daily operations from unlocking and opening the telepharmacy site to closing
			 and locking the telepharmacy site at the end of the business day. If the
			 telepharmacy site is protected by one or more alarm systems, training shall
			 include how to disarm and engage the alarm system or systems.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.12 - General Requirements for Telepharmacy Support Person

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Registration.
A
			 telepharmacy support person shall maintain registration in good standing with
			 the board as a pharmacy support person.
(2)
Training.
In addition to
			 training required of all pharmacy support persons, a telepharmacy support
			 person shall complete the following minimum training requirements before
			 practicing in a telepharmacy site. Records of telepharmacy support person
			 training shall be documented and maintained by the telepharmacy site.
a. Review and understanding of the policies
			 and procedures of the managing pharmacy.
b. Review and understanding of the policies
			 and procedures of the telepharmacy site.
c. Review and understanding of these rules
			 for telepharmacy practice.
d.
			 Review and understanding of pharmacy support person rules, 657-Chapter
			 5.
e. Understanding of the
			 operation of the audiovisual technologies to be utilized at both
			 pharmacies.
f. Training at the
			 telepharmacy site under the direct supervision of an on-site verifying
			 pharmacist. Training shall include operation and use of the audiovisual
			 technology and other means of communication between the telepharmacy site and
			 the managing pharmacy and the security of the telepharmacy site as identified
			 in policies and procedures.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.16 - Telepharmacy Site-initial Application

Current through Register Vol. 47, No. 3, July 24, 2024
A telepharmacy site shall complete and submit to the board a
				limited use/telepharmacy license application and nonrefundable fee as provided
				in rule 657-8.35 (155A) and, if
				controlled substances will be dispensed from the telepharmacy site, a CSA
				registration application and nonrefundable fee as provided in rule
				657-10.5 (124). As part of the
				limited use/telepharmacy license application, the telepharmacy site shall
				include the additional information identified in this rule.
(1)
Identification of managing
			 pharmacy.
The telepharmacy site application shall include
			 identification of the managing pharmacy, including pharmacy name, license
			 number, address, telephone number, and pharmacist in charge; a statement from
			 the managing pharmacy or pharmacist in charge indicating that the managing
			 pharmacy has executed a written agreement to provide the required services and
			 oversight to the telepharmacy site; and a statement from the pharmacist in
			 charge of the managing pharmacy designating the pharmacist in charge of the
			 telepharmacy site pursuant to subrule 13.9(3).
(2)
Distance to nearest pharmacy that
			 dispenses prescription drugs to outpatients.
The telepharmacy site
			 application shall identify the nearest currently licensed pharmacy that
			 dispenses prescription drugs to outpatients and shall provide evidence
			 identifying the total driving distance between the proposed telepharmacy site
			 and the nearest currently licensed pharmacy that dispenses prescription drugs
			 to outpatients.
a. If the distance between the
			 proposed telepharmacy site and the nearest currently licensed pharmacy that
			 dispenses prescription drugs to outpatients is less than ten miles, the
			 telepharmacy site shall submit a request for waiver of the distance
			 requirement. The process and requirements for a request for waiver are
			 identified in subrule 13.16(6).
b.
			 The distance requirement shall not apply under any of the following
			 circumstances:
(1) The telepharmacy site was
			 approved by the board and operating as a telepharmacy site prior to July 1,
			 2016.
(2) The proposed telepharmacy
			 site is located within a hospital campus, and services will be limited to
			 inpatient dispensing.
(3) The
			 proposed telepharmacy site is located on property owned, operated, or leased by
			 the state.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.18 - Opening of Traditional Pharmacy

Current through Register Vol. 47, No. 3, July 24, 2024
If a pharmacy licensed as a general, hospital, or limited use
				pharmacy opens for business within ten miles of an existing and operating
				telepharmacy site, the telepharmacy site may continue to operate as a
				telepharmacy site and shall not be required to close due to the proximity of
				the new pharmacy.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 13 - Telepharmacy Practice › Rule 657-13.23 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
Every inventory or other record required to be kept under Iowa
				Code chapters 124 and 155A or rules of the board shall be kept by the
				telepharmacy site and be available for inspection and copying by the board or
				its representative for at least two years from the date of the inventory or
				record except as specifically identified by law or rule. Controlled substances
				records shall be maintained in a readily retrievable manner in accordance with
				federal requirements and 657-Chapter 10.
(1)
Dispensing record.
A
			 written or electronic record identifying the pharmacist who verified the
			 prescription, the pharmacist who performed drug utilization review, the
			 pharmacist who provided counseling to the patient or the patient's caregiver,
			 and the pharmacy technician who filled the prescription shall be maintained for
			 every prescription fill dispensed by the telepharmacy site.
(2)
On-site pharmacist
			 staffing.
A written or electronic record of the number of
			 prescriptions filled, the number of on-site pharmacist hours, and the number of
			 hours the telepharmacy site was open for business each month shall be
			 maintained by the telepharmacy site.
(3)
Pharmacy access.
Records
			 identifying, by unique identification of the individual accessing the pharmacy
			 department, including the date and time of access, shall be maintained for two
			 years beyond the date of access.
(4)
Monthly inspection.
Reports of the monthly inspection of the telepharmacy site shall be maintained
			 at the telepharmacy site for two years following the date of the inspection. A
			 copy of the inspection report shall be provided to and maintained at the
			 managing pharmacy for two years following the date of the inspection.
(5)
Policy and procedure
			 review.
A written or electronic record of the review of the policy and
			 procedures by the pharmacist in charge shall be retained for two years
			 following the date of the review.