reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.13 - Security Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
All registrants shall provide effective controls and procedures
				to guard against theft and diversion of controlled substances. In order to
				determine whether a registrant has provided effective controls against
				diversion, the board shall use the security requirements set forth in these
				rules as standards for the physical security controls and operating procedures
				necessary to prevent diversion.
(1)
Physical security.
Physical security controls shall be
			 commensurate with the schedules and quantity of controlled substances in the
			 possession of the registrant in normal business operation. A registrant shall
			 periodically review and adjust security measures based on rescheduling of
			 substances or changes in the quantity of substances in the possession of the
			 registrant.
a. Controlled substances listed in
			 Schedule I shall be stored in a securely locked, substantially constructed
			 cabinet or safe.
b. Controlled
			 substances listed in Schedules II through V may be stored in a securely locked,
			 substantially constructed cabinet or safe. However, pharmacies and hospitals
			 may disperse these substances throughout the stock of noncontrolled substances
			 in a manner so as to obstruct the theft or diversion of the controlled
			 substances.
c. Controlled
			 substances collected via an authorized collection program for the purpose of
			 disposal shall be stored pursuant to federal regulations, which can be found at
			 http ://deadiversion.usdoj .gov/drug disposal/.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.14 - Accountability of Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
The registrant shall maintain ultimate accountability of
				controlled substances and records maintained at the registered location.
(1)
Records
. Pursuant
			 to rule 657-10.36 (124,155A), records
			 shall be available for inspection and copying by the board or its authorized
			 agents for two years from the date of the record.
(2)
Policies and procedures
.
			 The registrant shall have policies and procedures that identify, at a minimum:
a. Adequate storage for all controlled
			 substances to ensure security and proper conditions with respect to temperature
			 and humidity.
b. Access to
			 controlled substances and records of controlled substances by employees of the
			 registrant.
c. Proper disposition
			 of controlled substances.
d. To the
			 extent possible, a separation of duties related to the purchasing, receiving,
			 stocking, dispensing, and reconciling of controlled substance
			 inventory.
e. The reconciliation of
			 controlled substances in Schedule II pursuant to subrule 10.18(4).
f. The accountability measures for
			 controlled substances in Schedules III through V pursuant to rule
			 657-10.20(124).
g. A controlled
			 substance accountability program to document review of controlled substance
			 inventory adjustments, review patterns of controlled substance loss, and create
			 an action plan following a report of theft or loss pursuant to subrule
			 10.21(5).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.16 - Receipt and Disbursement of Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
Each transfer of a controlled substance between two
				registrants, to include a transfer between two separately registered locations
				regardless of any common ownership, except as provided in subrule 10.16(2),
				shall require a record of the transaction. Each registrant shall maintain a
				copy of the record for at least two years from the date of the transfer.
				Records of the transfer of Schedule II controlled substances shall be created
				and maintained separately from records of the transfer of Schedules III through
				V controlled substances pursuant to rule
				657-10.36 (124,155A).
				Upon receipt of a controlled substance, the individual responsible for
				receiving the controlled substance shall date and sign the receipt
				record.
(1)
Record.
The record, unless otherwise provided in these rules or pursuant to federal
			 law, 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 which 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 which the substances were distributed.
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 which the substances were distributed for disposal, if
			 appropriate.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.17 - Ordering or Distributing Schedule I or Ii Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
DEA
			 Form 222.
Except as otherwise provided by subrule 10.17(2) and under
			 federal law, a DEA Form 222 is required for each distribution of a Schedule I
			 or II controlled substance. An order form may be executed only on behalf of the
			 registrant named on the order form and only if the registrant's DEA and Iowa
			 registrations for the substances being purchased have not expired or been
			 revoked or suspended by the issuing agency.
a.
			 Order forms shall be obtained, executed, and filled pursuant to DEA
			 requirements. Each form shall be complete, legible, and properly prepared,
			 executed, and endorsed and shall contain no alteration, erasure, or change of
			 any kind.
b. The purchaser shall
			 submit Copy 1 and Copy 2 of the order form to the supplier.
c. The purchaser shall maintain Copy 3 of the
			 order form in the files of the registrant. Upon receipt of the substances from
			 the supplier, the purchaser shall record on Copy 3 of the order form the
			 quantity of each substance received and the date of receipt.
d. The supplier shall record on Copy 1 and
			 Copy 2 of the order form the quantity of each substance distributed to the
			 purchaser and the date on which the shipment is made. The supplier shall
			 maintain Copy 1 of the order form in the files of the supplier and shall
			 forward Copy 2 of the order form to the DEA district office.
e. Order forms shall be maintained separately
			 from all other records of the registrant.
f. Each unaccepted, defective, or otherwise
			 void order form and any attached statement or other documents relating to any
			 order form shall be maintained in the files of the registrant.
g. If the registration of any purchaser of
			 Schedule I or II controlled substances is terminated for any reason, or if the
			 name or address of the registrant as shown on the registration is changed, the
			 registrant shall return all unused order forms to the DEA district
			 office.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.19 - Physical Count and Record of Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
Each registrant shall be responsible for taking a complete and
				accurate inventory of all stocks of controlled substances under the control of
				the registrant pursuant to this rule. The responsible individual may delegate
				the actual taking of any inventory.
(1)
Record and procedure.
Each inventory record, except the
			 periodic count and reconciliation required pursuant to subrule 10.18(4), shall
			 comply with the requirements of this subrule and shall be maintained for a
			 minimum of two years from the date of the inventory.
a. Each inventory shall contain a complete
			 and accurate record of all controlled substances on hand on the date and at the
			 time the inventory is taken.
b.
			 Each inventory shall be maintained in a handwritten, typewritten, or
			 electronically printed form at the registered location. An inventory of
			 Schedule II controlled substances shall be maintained separately from an
			 inventory of all other controlled substances.
c. Controlled substances shall be deemed to
			 be on hand if they are in the possession of or under the control of the
			 registrant. Controlled substances on hand shall include prescriptions prepared
			 for dispensing to a patient but not yet delivered to the patient, substances
			 maintained in emergency medical service programs, care facility or hospice
			 emergency supplies, outdated or adulterated substances pending destruction, and
			 substances stored in a warehouse on behalf of the registrant. Controlled
			 substances obtained through an authorized collection program for the purpose of
			 disposal shall not be examined, inspected, counted, sorted, inventoried, or
			 otherwise handled.
d. A separate
			 inventory shall be made for each registered location and for each independent
			 activity registered except as otherwise provided under federal law.
e. The inventory shall be taken either prior
			 to opening or following the close of business on the inventory date, and the
			 inventory record shall identify either opening or close of business.
f. The inventory record, unless otherwise
			 provided under federal law, shall include the following information:
(1) The name of the substance.
(2) The strength and dosage form of the
			 substance.
(3) The quantity of the
			 substance, which shall be an exact count or measure of the substance and may
			 not be an estimated count or measure, except for liquid products packaged in
			 nonincremented containers, which may be estimated to the nearest one-fourth
			 container.
(4) Information required
			 of authorized collection programs pursuant to federal regulations for such
			 collection programs.
(5) The
			 signature of the person or persons responsible for taking the
			 inventory.
(6) The date and time
			 (opening or closing) of the inventory.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.20 - Schedule Iii Through v Accountability

Current through Register Vol. 47, No. 3, July 24, 2024
A registrant shall ensure accountability of Schedule III
				through V controlled substances through one or more of the measures identified
				herein.
1. Perpetual inventory log,
			 which may be maintained by electronic means, so long as the system complies
			 with the perpetual inventory requirements in rule
			 657-10.18 (124).
2. Documented audit and reconciliation of all
			 controlled substances every six months.
3. Routine documented cycle counts of
			 substances, so long as all controlled substances are counted every 90 days and
			 identified discrepancies are investigated and documented.
4. Other measure preapproved by the
			 board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.21 - Report of Theft or Loss

Current through Register Vol. 47, No. 3, July 24, 2024
A registrant shall report to the board and the DEA any theft or
				significant loss of controlled substances when the loss is attributable to
				other than inadvertent error. Thefts or other losses of controlled substances
				shall be reported whether or not the controlled substances are subsequently
				recovered or the responsible parties are identified and action taken against
				them.
(1)
Immediate notice to
			 board.
If the theft was committed by a registrant or licensee of the
			 board, or if there is reason to believe that the theft was committed by a
			 registrant or licensee of the board, the registrant from which the controlled
			 substances were stolen shall notify the board immediately upon discovery of the
			 theft and shall identify to the board the registrant or licensee suspected of
			 the theft.
(2)
Immediate
			 notice to DEA.
A registrant shall deliver notice, immediately upon
			 discovery of a reportable theft or loss of controlled substances, to the Des
			 Moines DEA field office via telephone, facsimile, or a brief written message
			 explaining the circumstances of the theft or loss.
(3)
Timely report
			 submission.
Within 14 calendar days of discovery of the theft or loss,
			 a registrant shall submit directly to the DEA a Form 106 or alternate required
			 form via the DEA website at
www.deadiversion.usdoj.gov/
. A copy
			 of the report that was completed and submitted to the DEA shall be immediately
			 submitted to the board via facsimile, email attachment, or personal or
			 commercial delivery.
(4)
Record maintained.
A copy of the report shall be maintained in
			 the registrant's files for a minimum of two years following the date the report
			 was completed.
(5)
Action
			 plan following loss.
Within seven days following the report of theft
			 or loss, a registrant shall develop and initiate implementation of an action
			 plan to address the conditions which contributed to the theft or loss. The
			 action plan shall include any directives, including, but not limited to,
			 inventory counts, audits, and perpetual inventory counts provided by a board
			 compliance officer.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.22 - Disposal of Registrant Stock

Current through Register Vol. 47, No. 3, July 24, 2024
A registrant shall dispose of controlled substances pursuant to
				the requirements of this rule. Disposal records shall be maintained by the
				registrant for at least two years from the date of the record.
(1)
Registrant stock supply.
Controlled substances shall be removed from current inventory and disposed of
			 by one of the following procedures.
a. The
			 registrant shall utilize the services of a DEA-registered and Iowa-licensed
			 reverse distributor.
b. The board
			 may authorize and instruct the registrant to dispose of the controlled
			 substances in one of the following manners:
(1) By delivery to an agent of the board or
			 to the board office.
(2) By
			 destruction of the drugs in the presence of a board officer, agent, inspector,
			 or other authorized individual.
(3)
			 By such other means as the board may determine to ensure that drugs do not
			 become available to unauthorized persons.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.23 - Disposal of Previously Dispensed Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Registrant disposal.
Except as provided in 657-Chapter 23 for care facilities, a registrant may not
			 dispose of previously dispensed controlled substances unless the registrant has
			 modified its registration with DEA to administer an authorized collection
			 program. A registrant shall not take possession of a previously dispensed
			 controlled substance except for reuse for the same patient or except as
			 provided in paragraph 10.23(2)
"b. "
(2)
Hospice disposal.
a. An employee of a hospice program, acting
			 within the scope of employment, may dispose of a controlled substance of a
			 hospice program patient following the death of the patient or the expiration of
			 the controlled substance pursuant to and in compliance with federal
			 law.
b. A physician of a hospice
			 program patient may dispose of a patient's controlled substance which is no
			 longer required due to a change in the patient's care plan.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.25 - Dispensing Records

Current through Register Vol. 47, No. 3, July 24, 2024
Each registrant shall create a record of controlled substances
				dispensed to a patient or research subject.
(1)
Record maintained and
			 available.
The record shall be maintained for two years from the date
			 of dispensing and be available for inspection and copying by the board or its
			 authorized agents.
(2)
Record contents.
The record shall include the following
			 information:
a. The name and address of the
			 person to whom dispensed.
b. The
			 date of dispensing.
c. The name or
			 NDC number, strength, dosage form, and quantity of the substance
			 dispensed.
d. The name of the
			 prescriber, unless dispensed by the prescriber.
e. The unique identification of each
			 technician, pharmacist, pharmacist-intern, prescriber, or prescriber's agent
			 involved in dispensing.
f. The
			 serial number or unique identification number of the
			 prescription.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.26 - Schedule Ii Emergency Prescriptions

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Emergency situation
			 defined.
For the purposes of authorizing an oral or facsimile
			 transmission of a prescription for a Schedule II controlled substance listed in
			 Iowa Code section
			 124.206,
			 the term "emergency situation" means those situations in which the prescribing
			 practitioner determines that all of the following apply:
a. Immediate administration of the controlled
			 substance is necessary for proper treatment of the intended ultimate
			 user.
b. No appropriate alternative
			 treatment is available, including administration of a drug that is not a
			 Schedule II controlled substance.
c. It is not reasonably possible for the
			 prescribing practitioner to provide a manually signed written prescription to
			 be presented to the pharmacy before the pharmacy dispenses the controlled
			 substance, or the prescribing practitioner is unable to provide a DEA-compliant
			 electronic prescription to the pharmacy before the pharmacy dispenses the
			 controlled substance.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.27 - Schedule Ii Prescriptions-partial Filling

Current through Register Vol. 47, No. 3, July 24, 2024
The partial filling of a prescription for a controlled
				substance listed in Schedule II is permitted as provided in this rule and
				federal regulations.
(1)
Insufficient supply on hand.
If the pharmacist is unable to
			 supply the full quantity authorized in a prescription and makes a notation of
			 the quantity supplied on the prescription record, a partial fill of the
			 prescription is permitted. The remaining portion of the prescription must be
			 filled within 72 hours of the first partial filling. If the remaining portion
			 is not or cannot be filled within the 72-hour period, the pharmacist shall so
			 notify the prescriber. No further quantity may be supplied beyond 72 hours
			 without a new prescription.
(2)
Long-term care or terminally ill patient.
A prescription for a
			 Schedule II controlled substance written for a patient in a long-term care
			 facility (LTCF) or for a patient with a medical diagnosis documenting a
			 terminal illness may be filled in partial quantities to include individual
			 dosage units as provided by this subrule.
a.
			 If there is any question whether a patient may be classified as having a
			 terminal illness, the pharmacist shall contact the practitioner prior to
			 partially filling the prescription. Both the pharmacist and the practitioner
			 have a corresponding responsibility to ensure that the controlled substance is
			 for a terminally ill patient.
b.
			 The pharmacist shall record on the prescription whether the patient is
			 "terminally ill" or an "LTCF patient." For each partial filling, the dispensing
			 pharmacist shall record on the back of the prescription or on another
			 appropriate uniformly maintained and readily retrievable record, the date of
			 the partial filling, the quantity dispensed, the remaining quantity authorized
			 to be dispensed, and the identification of the dispensing pharmacist.
c. The total quantity of Schedule II
			 controlled substances dispensed in all partial fillings shall not exceed the
			 total quantity prescribed. Schedule II prescriptions for patients in an LTCF or
			 for patients with a medical diagnosis documenting a terminal illness shall be
			 valid for a period not to exceed 60 days from the issue date unless sooner
			 terminated by the discontinuance of the drug.
d. Information pertaining to current Schedule
			 II prescriptions for patients in an LTCF or for patients with a medical
			 diagnosis documenting a terminal illness may be maintained in a computerized
			 system pursuant to rule
			 657-21.5
			 (124,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.28 - Schedule Ii Medication Order

Current through Register Vol. 47, No. 3, July 24, 2024
Schedule II controlled substances may be administered or
				dispensed to institutionalized patients pursuant to a medication order as
				provided in 657-subrule 7.13(1) or rule
				657-23.9
				(124,155A), as applicable.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.29 - Schedule Ii-issuing Multiple Prescriptions

Current through Register Vol. 47, No. 3, July 24, 2024
An individual prescriber may issue multiple prescriptions
				authorizing the patient to receive a total of up to a 90-day supply of a
				Schedule II controlled substance pursuant to the provisions and limitations of
				this rule.
(1)
Refills
			 prohibited.
The issuance of refills for a Schedule II controlled
			 substance is prohibited. The use of multiple prescriptions for the dispensing
			 of Schedule II controlled substances, pursuant to this rule, ensures that the
			 prescriptions are treated as separate dispensing authorizations and not as
			 refills of an original prescription.
(2)
Legitimate medical
			 purpose.
Each separate prescription issued pursuant to this rule shall
			 be issued for a legitimate medical purpose by an individual prescriber acting
			 in the usual course of the prescriber's professional practice.
(3)
Dates and instructions.
Each prescription issued pursuant to this rule shall be dated as of and
			 manually or electronically signed by the prescriber on the day the prescription
			 is issued. Each separate prescription, other than the first prescription if
			 that prescription is intended to be filled immediately, shall contain written
			 instructions indicating the earliest date on which a pharmacist may fill each
			 prescription.
(4)
Authorized fill date unalterable.
Regardless of the provisions
			 of rule 657-10.30 (124), when a
			 prescription contains instructions from the prescriber indicating that the
			 prescription shall not be filled before a certain date, a pharmacist shall not
			 fill the prescription before that date. The pharmacist shall not contact the
			 prescriber for verbal authorization to fill the prescription before the fill
			 date originally indicated by the prescriber pursuant to this rule.
(5)
Number of prescriptions and
			 authorized quantity.
An individual prescriber may issue for a patient
			 as many separate prescriptions, to be filled sequentially pursuant to this
			 rule, as the prescriber deems necessary to provide the patient with adequate
			 medical care. The cumulative effect of the filling of each of these separate
			 prescriptions shall result in the receipt by the patient of a quantity of the
			 Schedule II controlled substance not exceeding a 90-day supply.
(6)
Prescriber's discretion.
Nothing in this rule shall be construed as requiring or encouraging an
			 individual prescriber to issue multiple prescriptions pursuant to this rule or
			 to see the prescriber's patients once every 90 days when prescribing Schedule
			 II controlled substances. An individual prescriber shall determine, based on
			 sound medical judgment and in accordance with established medical standards,
			 how often to see patients and whether it is appropriate to issue multiple
			 prescriptions pursuant to this rule.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.30 - Schedule Ii-changes to a Prescription

Current through Register Vol. 47, No. 3, July 24, 2024
With appropriate verification, a pharmacist may add information
				provided by the patient or patient's agent, such as the patient's address, to a
				Schedule II controlled substance prescription.
(1)
Changes prohibited.
A
			 pharmacist shall never change the patient's name, the controlled substance
			 prescribed except for generic substitution, or the name or signature of the
			 prescriber.
(2)
Changes
			 authorized.
After consultation with the prescriber or the prescriber's
			 agent and documentation of such consultation, a pharmacist may change or add
			 the following information on a Schedule II controlled substance prescription:
a. The drug strength.
b. The dosage form.
c. The drug quantity.
d. The directions for use.
e. The date the prescription was
			 issued.
f. The prescriber's address
			 or DEA registration number.
g. The
			 name of the supervising prescriber if the prescription was issued by a
			 physician assistant.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.32 - Schedule Iii, Iv, or v Prescription

Current through Register Vol. 47, No. 3, July 24, 2024
No prescription for a controlled substance listed in Schedule
				III, IV, or V shall be filled or refilled more than six months after the date
				on which it was issued nor be refilled more than five times. Beginning January
				1, 2020, all prescriptions for controlled substances shall be transmitted
				electronically to a pharmacy pursuant to rule
				657-21.6 (124,155A), except as
				provided in rule 657-21.8 (124,155A).
(1)
Record.
Each filling and
			 refilling of a prescription shall be entered in a uniformly maintained and
			 readily retrievable record in accordance with rule
			 657-10.25 (124). If the
			 pharmacist merely initials or affixes the pharmacist's unique identifier and
			 dates the back of the prescription, it shall be deemed that the full face
			 amount of the prescription has been dispensed.
(2)
Oral refill
			 authorization.
The prescribing practitioner may authorize additional
			 refills of Schedule III, IV, or V controlled substances on the original
			 prescription through an oral refill authorization transmitted to an authorized
			 individual at the pharmacy provided the following conditions are met:
a. The total quantity authorized, including
			 the amount of the original prescription, does not exceed five refills nor
			 extend beyond six months from the date of issuance of the original
			 prescription.
b. The pharmacist,
			 pharmacist-intern, or technician who obtains the oral authorization from the
			 prescriber who issued the original prescription documents, on or with the
			 original prescription, the date authorized, the quantity of each refill, the
			 number of additional refills authorized, and the unique identification of the
			 authorized individual.
c. The
			 quantity of each additional refill is equal to or less than the quantity
			 authorized for the initial filling of the original prescription.
d. The prescribing practitioner must execute
			 a new and separate prescription for any additional quantities beyond the
			 five-refill, six-month limitation.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.33 - Dispensing Schedule v Controlled Substances Without a Prescription

Current through Register Vol. 47, No. 3, July 24, 2024
A controlled substance listed in Schedule V, which substance is
				not a prescription drug as determined under the federal Food, Drug, and
				Cosmetic Act, and excepting products containing ephedrine, pseudoephedrine, or
				phenylpropanolamine, may be dispensed or administered without a prescription by
				a pharmacist to a purchaser at retail pursuant to the conditions of this
				rule.
(1)
Who may
			 dispense.
Dispensing shall be by a licensed Iowa pharmacist or by a
			 registered pharmacist-intern under the direct supervision of a pharmacist
			 preceptor. This subrule does not prohibit, after the pharmacist has fulfilled
			 the professional and legal responsibilities set forth in this rule and has
			 authorized the dispensing of the substance, the completion of the actual cash
			 or credit transaction or the delivery of the substance by a
			 nonpharmacist.
(2)
Frequency and quantity.
Dispensing at retail to the same
			 purchaser in any 48-hour period shall be limited to no more than one of the
			 following quantities of a Schedule V controlled substance:
a. 240 cc (8 ounces) of any controlled
			 substance containing opium.
b. 120
			 cc (4 ounces) of any other controlled substance.
c. 48 dosage units of any controlled
			 substance containing opium.
d. 24
			 dosage units of any other controlled substance.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.34 - Dispensing Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine Without a Prescription

Current through Register Vol. 47, No. 3, July 24, 2024
A product containing ephedrine, pseudoephedrine, or
				phenylpropanolamine, which substance is a Schedule V controlled substance and
				is not listed in another controlled substance schedule, may be dispensed or
				administered without a prescription by an authorized dispenser pursuant to
				657-Chapter 100 to a purchaser at retail pursuant to the conditions of this
				rule.
(1)
Who may
			 dispense.
Dispensing shall be by an authorized dispenser pursuant to
			 657-Chapter 100. This subrule does not prohibit, after the dispenser has
			 fulfilled the professional and legal responsibilities set forth in this rule
			 and has authorized the dispensing of the substance, the completion of the
			 actual cash or credit transaction or the delivery of the substance by another
			 pharmacy employee.
(2)
Packaging of nonliquid forms. A
nonliquid form of a product
			 containing ephedrine, pseudoephedrine, or phenylpropanolamine includes gel
			 caps. Nonliquid forms of these products to be sold pursuant to this rule shall
			 be packaged either in blister packaging with each blister containing no more
			 than two dosage units or, if blister packs are technically infeasible, in unit
			 dose packets or pouches.
(3)
Frequency and quantity.
Dispensing without a prescription to
			 the same purchaser within any 30-day period shall be limited to products
			 collectively containing no more than 7,500 mg of ephedrine, pseudoephedrine, or
			 phenylpropanolamine; dispensing without a prescription to the same purchaser
			 within a single calendar day shall not exceed 3,600 mg.
(4)
Age of purchaser.
The
			 purchaser shall be at least 18 years of age.
(5)
Identification.
The
			 dispenser shall require every purchaser under this rule to present a current
			 government-issued photo identification, including proof of age when
			 appropriate. The dispenser shall be responsible for verifying that the name on
			 the identification matches the name provided by the purchaser and that the
			 photo image depicts the purchaser.
(6)
Record.
Purchase records
			 shall be recorded in the real-time electronic pseudoephedrine tracking system
			 (PTS) established and administered by the governor's office of drug control
			 policy pursuant to 657-Chapter 100. If the PTS is unavailable for use, the
			 purchase record shall be recorded in an alternate format and submitted to the
			 PTS as provided in 657-subrule 100.3(4).
a.
Alternate record contents.
The alternate record shall contain
			 the following:
(1) The name, address, and
			 signature of the purchaser.
(2) The
			 name and quantity of the product purchased, including the total milligrams of
			 ephedrine, pseudoephedrine, or phenylpropanolamine contained in the
			 product.
(3) The date and time of
			 the purchase.
(4) The name or
			 unique identification of the dispenser who approved the dispensing of the
			 product.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.36 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
Every record required to be kept under this chapter or under
				Iowa Code chapter 124 shall be kept by the registrant and be available for
				inspection and copying by the board or its representative for at least two
				years from the date of such record except as otherwise required in these rules.
				Controlled substances records shall be maintained in a readily retrievable
				manner that establishes the receipt and distribution of all controlled
				substances. Original records more than 12 months old may be maintained in a
				secure remote storage area unless such remote storage is prohibited under
				federal law . If the secure storage area is not located within the same
				physical structure as the registrant, the records must be retrievable within 48
				hours of a request by the board or its authorized agent.
(1) Schedule I and II r ecor ds. Records of
			 controlled substances listed in Schedules I and II shall be maintained
			 separately from all other records of the registrant.
(2)  Schedule III, IV , and V r ecor ds.
			 Records of controlled substances listed in Schedules III, IV , and V shall be
			 maintained either separately from all other records of the registrant or in
			 such form that the required information is readily retrievable from the
			 ordinary business records of the registrant.
(3) Date of r ecor d. The date on which a
			 controlled substance is actually received, imported, distributed, exported,
			 disposed of, or otherwise transferred shall be used as the date of receipt,
			 importation, distribution, exportation, disposal, or transfer.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.38 - Revision of Controlled Substances Schedules

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Designation of new controlled
			 substance.
The board may designate any new substance as a controlled
			 substance to be included in any of the schedules in Iowa Code chapter 124 no
			 sooner than 30 days following publication in the Federal Register of a final
			 order so designating the substance under federal law. Designation of a new
			 controlled substance under this subrule shall be temporary as provided in Iowa
			 Code section
			 124.201(4).
(2)
Objection to designation of a new
			 controlled substance.
The board may object to the designation of any
			 new substance as a controlled substance within 30 days following publication in
			 the Federal Register of a final order so designating the substance under
			 federal law. The board shall file objection to the designation of a substance
			 as controlled, shall afford all interested parties an opportunity to be heard,
			 and shall issue the board's decision on the new designation as provided in Iowa
			 Code section
			 124.201(4).
(3)
Cannabidiol
			 investigational product.
If a cannabidiol investigational product
			 approved as a prescription drug medication by the United States Food and Drug
			 Administration is eliminated from or revised in the federal schedule of
			 controlled substances by the DEA and notice of the elimination or revision is
			 given to the board, the board shall similarly eliminate or revise the
			 prescription drug medication in the schedule of controlled substances. Such
			 action by the board shall be immediately effective upon the date of publication
			 of the final regulation containing the elimination or revision in the Federal
			 Register.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.39 - Temporary Designation of Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
(1) Amend
			 Iowa Code section 124.204(2)  by adding the following new paragraphs:
cq.
			 2-methyl-N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide. Other name:
			 alpha'-Methyl butyryl fentanyl.
cr.
			 N-(1-(2,5-dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide. Other name:
			 2',5'-Dimethoxyfentanyl.
cs.
			 N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-3-carboxamide. Other name:
			 3-Furanyl fentanyl.
ct.
			 3-methyl-N-(1-phenethylpiperidin-4-yl)-N-phenylbutanamide. Other name:
			 Isovaleryl fentanyl.
cu.
			 N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide. Other name:
			 meta-Fluorofentanyl.
cv.
			 N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide. Other name:
			 meta-Fluoroisobutyryl fentanyl.
cw.
			 N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide. Other
			 name: ortho-Fluorofuranyl fentanyl.
cx.
			 N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide. Other
			 name: para-Methoxyfuranyl fentanyl.
cy.
			 N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide. Other
			 name: para-Methylcyclopropyl fentanyl.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.40 - Excluded and Exempt Substances

Current through Register Vol. 47, No. 3, July 24, 2024
The Iowa board of pharmacy hereby excludes from all schedules
				the current list of "Excluded Nonnarcotic Products" identified in Title 21, CFR
				Part 1308, Section 22. With the exception of listed butalbital products, the
				board hereby excludes from all schedules the current list of "Exempted
				Prescription Products" described in Title 21, CFR Part 1308, Section 32. Copies
				of such lists may be obtained by written request to the board office at 400
				S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.41 - Anabolic Steroid Defined

Current through Register Vol. 47, No. 3, July 24, 2024
Anabolic steroid, as defined in Iowa Code section
				126.2(2),
				includes any substance identified as such in Iowa Code section
				124.208(6)
				 or 126.2(2).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.42 - Additional Precursor Substances

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to Iowa Code section
				124B.2(2),
				the list of precursor substances identified in Iowa Code section
				124B.2(1)
				 is amended by adding the following new
				paragraph:
ab.
			 Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of
			 optical isomers. Other name: APAAN.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.43 - Reporting Discipline and Criminal Convictions

Current through Register Vol. 47, No. 3, July 24, 2024
A registrant shall provide written notice to the board of any
				disciplinary or enforcement action imposed by any licensing or regulatory
				authority on any license or registration held by the registrant no later than
				30 days after the final action. Discipline may include, but is not limited to,
				fine or civil penalty, citation or reprimand, probationary period, suspension,
				revocation, and voluntary surrender. A registrant shall provide written notice
				to the board of any criminal conviction of the registrant or of any owner that
				is related to the operation of the registered location no later than 30 days
				after the conviction. The term criminal conviction includes instances when the
				judgment of conviction or sentence is deferred.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.44 - Discipline

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to 657-Chapter 36, the board may fine, suspend,
				revoke, or impose other disciplinary sanctions on a registration for any of the
				following:
1. Any violation of the
			 federal Food, Drug, and Cosmetic Act or federal regulations promulgated under
			 the Act.
2. Any conviction of a
			 crime related to controlled substances committed by the registrant, or if the
			 registrant is an association, joint stock company, partnership, or corporation,
			 by any managing officer.
3.
			 Refusing access to the registered location or registrant records to an agent of
			 the board for the purpose of conducting an inspection or
			 investigation.
4. Failure to
			 maintain registration pursuant to 657-Chapter 10.
5. Any violation of Iowa Code chapter 124,
			 124B, 126, 155A, or 205, or any rule of the board, including the disciplinary
			 grounds set forth in 657-Chapter 36.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.2 - Responsibility

Current through Register Vol. 47, No. 3, July 24, 2024
Each service program shall appoint a service director at the
				primary program site and shall have a responsible individual who is responsible
				for ensuring that the management of all prescription drugs complies with
				federal and state laws and regulations. In service programs that maintain both
				a pharmacy-based service program agreement and a medical director-based service
				program agreement, the responsible individual for each service program
				agreement shall be responsible for ensuring the management of drugs under that
				individual's ownership. If more than one pharmacy enters into an agreement with
				a pharmacy-based service program, the pharmacist in charge at each pharmacy is
				responsible for the rules and laws pertaining to the specific prescription
				drugs, including controlled substances, that each pharmacy provides to the
				service program.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.4 - Written Agreement

Current through Register Vol. 47, No. 3, July 24, 2024
A signed, written agreement for the service program shall be
				maintained at the primary program site and be available for inspection and
				copying by the board, its representative, or any other authorized
				individual.
(1)
Pharmacy-based
			 service programs.
An Iowa-licensed pharmacy may enter into an
			 agreement with a service program located in the state. The agreement with the
			 service program shall establish that the service program is operating as an
			 extension of the pharmacy with respect to the prescription drugs the pharmacy
			 provides to the service program. The agreement shall be signed by the
			 pharmacist in charge and the service director at the primary program site. A
			 copy of this agreement shall be maintained at both the pharmacy and the primary
			 program site while the agreement is in effect. Nothing in this rule prohibits
			 more than one pharmacy from entering into an agreement with a service program
			 provided that each pharmacy complies with all rules and regulations for a
			 pharmacy-based service program, including maintenance of all required records
			 specific to each pharmacy's drugs.
(2)
Medical director-based service
			 programs.
An Iowa-licensed physician may enter into an agreement with
			 a service program located in the state. The agreement shall be signed by the
			 medical director and the service director and be maintained at the primary
			 program site while the agreement is in effect. The agreement shall include an
			 attestation that the medical director agrees to abide by these rules.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.5 - Termination of Agreement

Current through Register Vol. 47, No. 3, July 24, 2024
A written agreement may be terminated at the discretion of
				either the service program or the party or parties responsible for providing
				drugs to the service program. Written notification of such termination shall be
				provided to the other party at least 30 days prior to termination of the
				agreement.
(1)
Pharmacy-based
			 service programs.
Immediately upon discontinuation of a written
			 agreement, all controlled substances shall be jointly inventoried by the
			 pharmacist in charge of the pharmacy that owns the drugs and the service
			 director or their respective designees. A record of this inventory shall be
			 maintained at the pharmacy for two years from the date of the inventory and
			 shall be available for inspection and copying by the board, its representative,
			 or any other authorized individual. All drugs and devices that are the property
			 of the pharmacy shall be immediately returned to the pharmacy.
(2)
Medical director-based service
			 programs.
Immediately upon discontinuation of a written agreement, all
			 controlled substances shall be jointly inventoried by the medical director and
			 the service director or their respective designees. A record of this inventory
			 shall be maintained by the medical director for two years from the date of the
			 inventory and shall be available for inspection and copying by the board, its
			 representative, or any other authorized individual. All drugs and devices that
			 are the property of the medical director shall be immediately returned to the
			 medical director.
(3)
Transfer of ownership.
If drugs in a service program are to be
			 maintained under the ownership of a new pharmacy or medical director, such
			 transfer of ownership shall be in compliance with 657-Chapter 10, 657-Chapter
			 17, and federal laws and regulations. Pursuant to rule
			 657-10.34
			 (124,155A), the transfer of Schedule II controlled substances shall require an
			 executed DEA Form 222.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 11 - Drugs in Emergency Medical Service Programs › Rule 657-11.8 - Identification

Current through Register Vol. 47, No. 3, July 24, 2024
A log of employees who have access to prescription drugs and to
				records regarding procurement, storage, and administration of prescription
				drugs at the service program shall be maintained for two years and be available
				for inspection and copying by the board, its representative, or any other
				authorized individual. This log shall include each employee's printed name and
				signature, printed and signed initials or other unique identification used in
				service program records, and the employee's level of certification. A service
				program may maintain an electronic record of employee identification, including
				the employee's name, signature, unique identification used in the service
				program records, and level of certification. Such log shall be maintained at
				the primary program site for at least two years from the date of the employee's
				last date of employment with the service program and shall be available for
				inspection and copying by the board, its representative, or any other
				authorized individual.