FOLLOWING IS THE AMENDED TEXT OF THE PENDING RULE FOR DOCKET NO. 27-0101-1207

029. PHARMACIST LICENSE OR REGISTRATION.

01. Practice in Idaho. All pharmacists practicing pharmacy in the state of Idaho must be licensed according to the Board's laws. (7-1-13)

02. Practice Into Idaho. Unless statutorily exempted, all pharmacists practicing pharmacy into the state of Idaho must be licensed or registered as follows: (7-1-13)

a. The following pharmacists must be licensed to provide centralized pharmacy services into Idaho: (7-1-13)

i. Pharmacists engaged in the independent practice of pharmacy across state lines as defined by the Pharmacist Independent Practice Rule. (7-1-13)

ii. Pharmacists practicing from a central drug outlet that is not a pharmacy. (7-1-13)

iii. Pharmacists practicing from a remote office location. ( )

b. The following pharmacists not licensed in Idaho must be registered to practice pharmacy into Idaho. (7-1-13)

i. The PIC or director of a nonresident central drug outlet or mail service pharmacy. (7-1-13)

ii. Pharmacists practicing from a pharmacy or its COE. (7-1-13)

(BREAK IN CONTINUITY OF SECTIONS)

035. PHARMACIST REGISTRATION TO PRACTICE PHARMACY INTO IDAHO. To be registered to practice pharmacy into Idaho an applicant must submit an application in the manner and form prescribed by the Board including, but not limited to: (7-1-13)

01. Individual License Information. Current pharmacist licensure information in all other states, including each state of licensure and each license number; (7-1-13)

02. Facility License Information. The license or registration number of the facility from for which the applicant will be practicing. (7-1-13)( )

(BREAK IN CONTINUITY OF SECTIONS)

050. CPE: PROGRAM CRITERIA.

01. Board Approval of CPE Programs. The Board recognizes CPE program accreditation by ACPE and CME. CPE programs not accredited by either ACPE or CME must be approved by the Board. Application for approval will require provision of the following information A sponsoring organization, presenter or continuing education coordinator may apply to the Board for accreditation of a CPE program. An application must be submitted twenty-one (21) days in advance of the program and must include: (3-21-12)( )

a. The name of provider or sponsor the sponsoring organization, if applicable; (3-21-12)( )

b. The type title of the program offered; (3-21-12)( )

c. The learning objectives and Aa description of the subject matter; (3-21-12)( )

d. The number of clock hours offered method and materials for assessing the learning objectives; (3-21-12)( )

e. The method of evaluating satisfactory completion of the program; (3-21-12)( )

f. The dates, time schedule, number of clock hours and location of the program; and (3-21-12)( )

g. The names and qualifications curriculum vitae or resume of instructors or other persons responsible for the delivery and content of the program.; and (3-21-12)( )

h. A copy of the materials to be offered to the participants and the program to be presented (electronic or hard copy), if applicable. ( )

02. Postgraduate Education. A CPE program must consist of postgraduate education in one or more of the following general areas: (3-21-12)

a. The socioeconomic and legal aspects of health care; (3-21-12)

b. The properties and actions of drugs and dosage forms; or (3-21-12)

c. The etiology, characteristics, and therapeutics of a disease state. (3-21-12)

03. Evidence of Satisfactory Completion. A CPE program must provide evidence of satisfactory completion by participants. (3-21-12)

04. Qualified Instruction. The program presenter must be qualified in the subject matter by education or experience. (3-21-12)

(BREAK IN CONTINUITY OF SECTIONS)

052. CPE: REQUIREMENTS.

Each pharmacist applicant for license renewal must annually complete fifteen (15) CPE hours. (4-4-13)

01. ACPE or CME. At a minimum, eight twelve (812) of the CPE hours obtained must be all or a combination of ACPE or CME accredited programs. ACPE accredited activities must have a participant designation of "P" (for pharmacist) as the suffix of the ACPE universal program number. (4-4-13)( )

02. Pharmacy Law. One (1) of the CPE hours obtained must be ACPE accredited or Board approved jurisprudence (pharmacy law) programs address federal, state or local law effecting the practice of pharmacy. (4-4-13)( )

03. Board Approved. A maximum of six three (63) of the CPE hours obtained may be Board-approved programs not accredited through ACPE or CME. (4-4-13)( )

04. Live Attendance. Three (3) of the CPE hours obtained must be by attendance at live or synchronous online CPE programs. (4-4-13)

05. Immunizer Qualification. To maintain qualification to administer immunizations, a minimum of one (1) of the ACPE-approved CPE hours must be related to vaccines, immunizations, or their administration. (4-4-13)

06. Sterile Compounding Requirement. To engage in the practice of sterile compounding a minimum of one (1) of the CPE hours must be ACPE accredited and related to the practice of sterile compounding. ( )

067. Carryover of Certain Unused Units. CPE hours accrued during June of a licensing period may be carried over into the next licensing period to the extent that a pharmacist's total CPE hours for the current licensing period exceed the total CPEs hours required by these rules. (4-4-13)

078. New Pharmacist Exemption. Recent pharmacist graduates applying for the first license renewal are not required to complete or certify the annual CPE requirements. (3-21-12)

0539. CPE: Requirements for Dual Licenses. ( )

01a. Idaho Licensee. An Idaho-licensed pharmacist residing in another state must meet Idaho CPE requirements to be granted an Idaho license renewal. (3-21-12)( )

02b. Approval. CPE programs attended by an Idaho-licensed pharmacist for purposes of satisfying licensing requirements of another state must be accredited by either ACPE or CME or must be approved by the Board to also be recognized for purposes of renewal of the pharmacist's Idaho license. (3-21-12)( )

0543. -- 059. (RESERVED)

(BREAK IN CONTINUITY OF SECTIONS)

111. PRESCRIPTION DRUG ORDER: MINIMUM REQUIREMENTS.

A prescription drug order must comply with applicable requirements of federal law and, except as differentiation is permitted for a drug order, must include at least the following: (3-21-12)

01. Patient's Name. The patient's name and: (3-21-12)

a. If for a controlled substance, the patient's full name and address; and (3-21-12)

b. If for an animal, the species. (3-21-12)

02. Date. The date issued. (3-21-12)

03. Drug Information. The drug name, strength, quantity, and if for a controlled substance, the dosage form. (3-21-12)

04. Directions. The directions for use. (3-21-12)

05. Prescriber Information. The name and, if for a controlled substance, the address and DEA registration number of the prescriber. (3-21-12)

06. Signature. If paper, the pre-printed, stamped, or hand-printed name and written signature of the prescriber, or if statutorily allowed, the prescriber's agent's signature, and if electronic, the prescriber's electronic signature. (3-21-12)( )

112. DRUG ORDER: MINIMUM REQUIREMENTS.

A drug order must comply with applicable requirements of federal law and must include at least the following: (3-21-12)

01. Patient's Name. The patient's name. (3-21-12)

02. Date. The date issued. (3-21-12)

03. Drug Information. The drug name, strength, and route of administration. (3-21-12)

04. Directions. The directions for use. (3-21-12)

05. Prescriber Information. The name of the prescriber. (3-21-12)

06. Signature. If written, the signature of the prescriber or if statutorily allowed, the prescriber's agent. (3-21-12)( )

(BREAK IN CONTINUITY OF SECTIONS)

202. CONTROLLED SUBSTANCES: NON-PRESCRIPTION DISPENSING.

A Schedule V non-prescription controlled substance may be dispensed to a retail purchaser as permitted or restricted by these rules. (3-21-12)

01. Dispensing by a Technician Prohibited. Technicians are prohibited from dispensing a nonprescription controlled substance even if under the direct supervision of a pharmacist, but may transact the sale and deliver the product after the pharmacist has fulfilled his professional and legal responsibilities. (3-21-12)

02. Restricted Quantity. No more than four (4) ounces of liquid containing a maximum of two hundred (200) milligrams of codeine per one hundred (100) milliliters or per one hundred (100) grams may be distributed at retail to the same purchaser in any forty-eight (48) hour period. (3-21-12)( )

03. Purchaser's Age. A purchaser of a non-prescription controlled substance must be at least eighteen (18) years of age. (3-21-12)

04. Identification Required for Purchase. The pharmacist must obtain positive identification as required by these rules that, if appropriate, includes proof of age of the purchaser of a non-prescription Schedule V controlled substance. (3-21-12)

05. Bound Record Book and Patient Signature Required. A bound record book must be used to document sales of non-prescription Schedule V controlled substances and must record the following: (3-21-12)

a. The name and address of the purchaser; (3-21-12)

b. The name and quantity of the controlled substance purchased; (3-21-12)

c. The date of the purchase; (3-21-12)

d. The name or initials of the pharmacist who dispensed the substance to the purchaser; and (3-21-12)

e. The signature of the purchaser. (3-21-12)

(BREAK IN CONTINUITY OF SECTIONS)

604. PHARMACY PRODUCT STORAGE AND REMOVAL.

Prescription drugs, devices, and other products restricted to sale or dispensing by, or under the supervision of, a pharmacist must be stored in the pharmacy and must not be sold, delivered, or otherwise removed from a pharmacy unless a pharmacist is present, except: ( )

01. Emergency Drug Access and Pharmacist Absence. aAs allowed by these rules for emergency access to an institutional pharmacy.; ( )

02. Institutional Facility Alternative Storage. In an institutional facility these restricted products may also be stored in an alternative designated area that is appropriately equipped to ensure compliance with drug product storage requirements, to provide adequate security and protection from diversion, and that otherwise complies with applicable requirements of these rules.; (3-21-12)( )

03. Storage for Delivery. Filled prescriptions may be picked up for delivery from a pharmacy when the pharmacy is closed for business if: ( )

a. The prescriptions are placed in a secured delivery area equipped with adequate security, including an alarm or comparable monitoring system, to prevent unauthorized entry, theft and diversion; ( )

b. The secured delivery area has walls that extend to the roof and solid core or metal doors, and all doors and other access points must be equipped with locking devices and be constructed in a manner so that the hinge hardware is accessible only from inside the secured delivery area; ( )

c. The secured delivery area appropriately safeguards product integrity in accordance with USP-NF requirements; ( )

d. The secured delivery area is attached or located adjacent to the pharmacy that filled the prescriptions; ( )

e. The PIC, or a pharmacist designated by the PIC, and the approved transport agent solely have access to the secure delivery area. Two (2) factor credentialing is required for entry, which must include two (2) of the following: ( )

i. Something you know (a knowledge factor); ( )

ii. Something you have (a hard token stored separately from the computer being accessed); and( )

iii. Something you are (biometric information); ( )

f. The pharmacy has a means of recording the time of entry and the identity of all persons who access the secured delivery area; ( )

g. The pharmacy maintains immediately retrievable records of all persons who have accessed the secured delivery area and each prescription stored and removed for delivery; ( )

h. The pharmacy maintains written policies and procedures for secured delivery area storage and removal of prescriptions; and ( )

i. The PIC of a pharmacy that ships drugs by common carrier must require the common carrier to conduct criminal background checks on its employees who have access to the secured delivery area. ( )

04. Qualified Returns to the Secured Delivery Area. A pharmacist or a pharmacy, by means of its agent, may accept the return of the following drugs or devices to the secured delivery area: ( )

a. Emergency kits; ( )

b. Prescriptions that were unsuccessfully delivered by the pharmacy, a pharmacist, or its agent; and ( )

c. Those deemed qualified for return pursuant to the Restricted Return of Drugs or Devices rule. ( )

605. PHARMACY SECURITY.

01. Basic Security Standards. A pharmacy must be constructed and equipped with adequate security, and at least while closed, utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use. Pharmacies without an alarm or other monitoring system as of the effective date of this rule must comply with this rule upon completion of a structural remodel. (3-21-12)

02. Non-Institutional Pharmacy Security During Pharmacist Absence. A non-institutional pharmacy must be closed for business and secured during all times a pharmacist is not present except: (4-4-13)

a. If a technician or student pharmacist is on to duty, to allow brief pharmacist absences within the business establishment; or (4-4-13)

b. To perform professional services in the peripheral areas immediately outside of the pharmacy. (4-4-13)

03. Structural Security Requirements. If a pharmacy is located within an establishment that is open to the public for business at times when a pharmacist is not present, the pharmacy must be totally enclosed in a manner sufficient to provide adequate security for the pharmacy, as required by this rule and approved by the Board. All pharmacies must meet the following security requirements: (3-21-12)( )

a. Pharmacy walls must extend to the roof or the pharmacy must be similarly secured from unauthorized entry. (3-21-12)

b. Solid core or metal doors are required for new or remodeled pharmacies after the effective date of this rule. (4-4-13)

c. Doors and other access points must be constructed in a manner that the hinge hardware is accessible only from inside of the pharmacy and must be equipped with locking devices. (3-21-12)

d. If used, a "drop box" or "mail slot" allowing delivery of prescription drug orders to the pharmacy during hours closed must be appropriately secured against theft, and the pharmacy hours must be prominently visible to the person depositing the prescription drug order. Prescriptions must not be accepted for delivery to the pharmacy or for depositing in the drop box by non-pharmacy employees of a retail establishment. (3-21-12)

04. Restricted Access to the Pharmacy. No one must be allowed entrance to the closed and secured pharmacy unless under the direct supervision of a pharmacist or except as permitted by these rules for an institutional pharmacy. (3-21-12)