RX 526: Exam 3

What is the Indiana Board of Pharmacy made up of?

- 7 total members

- 1 pharmacy technician

- 5 pharmacists (1 MUST be hospital pharmacist)

- 1 consumer member

- Officers: President and Vice President

- Must meet at least 8 times per year

Powers and Duties of Board

- Board may do certain tasks (refuse to discipline licensees, adopt certain rules, regulate sale of drugs, etc.)

- Board SHALL adopt rules and procedures for electronic transmission of prescriptions

License Sanctions by the Board

- Censure

- Reprimand

- Probation

- Suspension

- Summary Suspension

- Revocation

- Fine

Censure

Expression of official disapproval (usually verbal); does not affect status of licensee or licensee's ability to practice

Reprimand

Official record (written) that licensee has been disciplined. Does not affect status of licensee or licensee's ability to practice

Probation

Licensee may continue to practice, but are subject to certain terms and conditions

Suspension

Cannot practice. Typically imposed for indefinite period; Board sets minimum time that must pass before applying for reinstatement. Sometimes followed by probation

Summary suspension

90-day suspension based on finding that licensee represents "clear and immediate danger to public health and safety"

Revocation

Cannot practice. License CANNOT be reinstated. Licensee must wait minimum of 7 years before applying for new license

Fine

Up to $1000 per violation

License Types

- Active

- Inactive

- Surrendered

- Expired

License Types: Active

fees & CE current

License Types: Inactive

Keep license by paying renewal fee, but exempt from CE. CANNOT practice

License Types: Surrendered

License given up. CANNOT practice

License Types: Expired

license that is not renewed. CANNOT practice

Third party logistics provider

provides/coordinates storage, distribution, other services on behalf of manufacturer, but does not have responsibility to direct legend drug's sale

Wholesale distributor

distributes legend drugs to entities other than the consumer (manufacturers, repackagers, brokers, wholesale drug traders, reverse distributors, pharmacies that conduct wholesale distribution, etc. )

Do Wholesale distributors need a state license?

Need state license

Do third-party logistics providers need a state license?

- Need National Association of Board of Pharmacy's Verified Accredited Wholesale Distributor certificate

- State license (and pay fee)

Wholesale Distribution Exemptions (YOU do not need a wholesaler license if you do these things...)

- Sale/transfer between entities under common ownership and control

- Purchase by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the entity's own use from the GPO or other members of the GPO

- Sale among hospitals/health care entities under common control

- Sale/transfer drug by a charitable organization to nonprofit affiliate or nonprofit entity (501C3)

- Sale for emerqencv medical reasons (such as druq shortaqes in retail pharmacies)*

--- gross dollar value of transfers cannot exceed 5% of total legend drug sales at transferor or transferee pharmacy during any 12 consecutive month period (this is NOT just limited to retail pharmacies)

- Sale of drug by retail pharmacy to a practitioner for office use*

--- gross dollar value of transfers cannot exceed 5% of total legend drug sales at pharmacy during any 12 consecutive month period

- Sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use

- Sale/dispensing of drug due to a prescription

- Distribution of drug samples by manufacturers/distributors

- Sale of blood and blood components for transfusion

- Sale of a drug by retail pharmacy that is ending its business and liquidating inventory to another retail pharmacy*

- Drug returns by hospital, health care entity, or charitable institution under 21 CFR 203.23

- Distribution of prescription drugs by manufacturer to a partner of manufacturer

- Drug returns*

Indiana Legend Drug Act: Unlawful Acts

- Obtain or attempt to maintain a drug by:

--- Fraud, deceit, misrepresentation, or subterfuge

--- Forgery or alteration of a prescription or order

--- Concealment of material fact

--- Use of false name or address

- Communicate information to a physician to unlawfully obtain a drug

- Make a false statement

- Commit fraud by:

--- Falsely claim to be a manufacturer, wholesaler, pharmacist, physician, dentist, veterinarian, etc.

--- Make or forge prescription

--- Add false/forged label to a package containing legend drugs

--- Dispense legend drug illegally

Indiana Legend Drug Act: Law enforcement

- Law enforcement officers are exempt from prosecution for and may not be convicted of violations of this chapter

--- When acting in their official duties

- Those who do illegal things to help are not immune

Indiana State Law: Controlled Substances - Low THC hemp extract

- Derived from or contains any part of plant Cannabis sativa L

- Contains not more than three-tenths percent (0.3%) of THC and

- Contains no other controlled substances

Indiana State Law: Controlled Substances - Dextropropoxyphene

C-IV

Indiana State Law: Controlled Substances - Sibutramine

C-IV

Indiana State Law: Controlled Substances - ALL butalbital products (INCLUDING Fioricet!)

C-III

Indiana State Law: Controlled Substances - Codeine

- C-II

- C-III: if 1.8 grams or less per 100 mL or 90m or less per dosage unit

- C-V: 200 mg or less per 100 mL or 100 grams

Pharmacist License Requirements

- At least 18 years of age

- No convictions (for a crime that has a direct bearing on ability to practice competently)

- Graduated with school of pharmacy accredited by the Accreditation Council for Pharmacy Education or the "Canadian Council for Accreditation of Pharmacy Programs" (CCAPP)

--- If Canadian graduate, must obtain Foreign Pharmacy Graduate Examination Committee Certificate (FPGECC) OR Graduated outside of the US and Canada

--- Provide board with verification of academic record and graduation AND

--- Obtain FPGECC

- And Pass the NAPLEX

Intern License Requirements

- Actively enrolled in a school of pharmacy accredited by ACPE OR

- Obtained FPGECC OR

- Qualified applicant awaiting the examination for licensure as a pharmacist

Passing score (for NAPLEX)

- 75

- This is NOT a percentage; it is a scaled score

- You won't see your score

Reexamination (for NAPLEX)

- Must file new complete application to test if exam is failed

--- May include affidavits or data concerning experience in pharmacy and attendance at college of pharmacy by referring to original application

- If fail exam after 2 sittings, must appear before the Board and receive written permission to retest

- Pro tip: Ensure your intern license doesn't expire before you pass the NAPLEX!

Practical Experience Requirement

- Must have active intern license to obtain practical experience in Indiana

- Site must have pharmacy permit if required by law to have one

- Practical experience requirements may be satisfied by:

--- Completion of education from college/school accredited by ACPE or Canadian Council on Pharmacy Accreditation or board-approved program

- If graduated from nonaccredited program or program with no practical experience, must complete 1500 hours of experience

- If licensed as pharmacist in another state and engaged in practice for a year or more, practical experience requirement waived

Affidavits and Out of State Experience

- Practical experience must be verified by signed affidavits at the end of each period of experience

- Must hours per week and show time served each week

- Experience outside of Indiana counts

--- If experience meets requirements of Indiana and experience is acceptable to the Board

--- Applicant has valid intern license from state where experience conducted or if state does not require intern license, must submit certification/affidavit from secretary of Board of Pharmacy in that state

Pharmacist License Reciprocity

- Getting licensed in one state and transferring to another state (license transfer)

- Can be licensed in Indiana if qualifications for licensure, possessed at time of the original registration in the originating state, were equal to requirements of Indiana at the time

- Must submit photograph and application

- May need to appear before Board for interview happen usually)

- May need to pass practical exam if not actively practicing pharmacy for previous 12 months

--- This means pass the NAPLEX again

Display of Certificate in Pharmacy

- Certificates of licensure shall be conspicuously displayed

- Failure to comply with this rule shall be deemed sufficient cause for suspension or revocation of the license

- Need to display pharmacist, intern, technician licenses

Illegal Display of Certificate

Illegal to display a license of someone who does not work at the drug store, pharmacy, hospital, dispensary, or other place were drugs are sold and dispensed

Address Change and Mail from the Board

- Pharmacists licensed in Indiana must notify the Board of address changes

- If the Board mails a notice to the person concerned, they have done their duty

--- They do not have to verify the recipient received the notice

Prohibitions: Pharmacists and interns must not violate

- Indiana Controlled Substances Act

- Indiana Legend Drug Act

- Indiana Uniform Food, Drug, and Cosmetic Act

- Indiana Pharmacy Practice Act

- Federal Food, Drug, and Cosmetic Act

- Federal Controlled Substances act and regulations

- Executive proclamations of the President that pertain to drugs or devices

Prohibitions for Pharmacists and interns

- Cannot sell a drug that is "not in good faith"

- Cannot aid or abet anyone who is practicing pharmacy without a license

- Cannot practice pharmacy incompetently or negligently

Technician License Requirements

- At least 18 years of age

- Graduated from high school OR received high school equivalency certificate OR state general development (GED) diploma

- Has not been convicted of:

--- Crime that has a direct bearing upon the individual's ability to practice competently OR

--- Felony involving controlled substances

- Graduated from technician education and training program approved by the board QR

- Successfully passed certification examination offered by Pharmacy Technician Certification Board or another nationally recognized certification body approved by the board

Qualifications of Pharmacy Technicians

- Cannot be convicted of a crime that has direct bearing on ability to work with drugs

- High school graduate or GED completion

- Completed or enrolled in and successfully completed within 12 months:

--- Comprehensive curricular-based education and training program,

--- Technician training program by employer,

--- OR board-approved certification examination

- Must keep record of pharmacy technician training and education in pharmacy

Qualifications for Pharmacy Technician in Training permit

- At least 18 years of age

--- Board may waive age restriction

- Has not been convicted of a crime that has a direct bearing upon the individual's ability to practice competently

- Has applied for pharmacy technician licensure

- Applicant may work as a tech-in-training for up to 30 days after filing an application (while waiting on it to be processed)

--- Applicant must show employer date application was filed and that fee was paid

--- Additional 30-day grace period may be requested

Pharmacy Technician in Training Permit expires

- 60 days after date permit holder completes board-approved program OR

- 12 months after issuance

- whichever is earlier

Purpose and Scope: of technicians, pharmacists, and interns

- Pharmacy technicians assist pharmacists with nondiscretionary functions associated with practice of pharmacy

--- Enables pharmacist to provide pharmaceutical care to patient

- Only pharmacists, interns, technicians shall be permitted to participate in activities associated with drug order or prescription preparation

- Technicians must meet certain qualifications

- Pharmacist responsible for work performed by technician

Duties that a Pharmacy Technician May Not Perform

- Any duty required by law, regulation, or rule to be performed by a pharmacist

- Dispensing prescription drug information to the patient (What do you think this means?)

- Provision of advice or consultation with the prescriber or other licensed health care provider regarding the patient or interpretation and application contained in prescription/drug order

- Receipt of a verbal prescription, other than refill approval or denial from a prescriber

- Receive a new prescription drug order over the telephone or electronically unless the original information is recorded so a pharmacist may review the prescription drug order as transmitted

- Provision of advice or consultation with the patient

- Final check on all aspects of completed prescription and assumption of responsibility for the filed prescription (This says PRESCRIPTION, not drug order)

Pharmacy Technician Identificatio

- wear identification clearly stating that the person is a pharmacy technician, and

- identify himself or herself verbally in an telephonic or electronic communication

Pharmacist Duties: Final check on prescriptions (Y/N?)

Y

Pharmacist Duties: Counseling (Y/N?)

Y

Pharmacist Duties: Sell syringes (Y/N?)

Y

Pharmacist Duties: Administer immunizations (Y/N?)

Y

Pharmacist Duties: Transfer prescriptions (Y/N?)

Y

Pharmacist Duties: Receive telephone prescriptions (Y/N?)

Y

Intern Duties: Final check on prescriptions (Y/N?)

N

Intern Duties: Counseling (Y/N?)

Y (still need to offer pharmacist counselling)

Intern Duties: Sell syringes (Y/N?)

Y

Intern Duties: Administer immunizations (Y/N?)

Y

Intern Duties: Transfer prescriptions (Y/N?)

Y

Intern Duties: Receive telephone prescriptions (Y/N?)

Y

Technician Duties: Final check on prescriptions (Y/N?)

N

Technician Duties: Counseling (Y/N?)

N

Technician Duties: Sell syringes (Y/N?)

N

Technician Duties: Administer immunizations (Y/N?)

Y

Technician Duties: Transfer prescriptions (Y/N?)

Y

Technician Duties: Receive telephone prescriptions (Y/N?)

Y (only if on voicemail or refill or denial of a prescription)

Is Tech verification of drug orders is permitted?

Yes, they can do the "final check" of the product

Definitions: "In personal attendance"

Physically present in the area specified as the pharmacy by the permit application

Definitions: "Reasonable visual and vocal distance"

- Pharmacist being physically present within the licensed permitted area or

- By a means that provides for adequate supervision of technicians (approved by Board)

Definitions: Supervision

- Physical or real-time act of oversight and management by a pharmacist of another individual's work

- Direct line of sight and hearing or via technology

Supervision of Pharmacy Interns, Technicians, Technicians in Training

Pharmacy technicians and technicians in training must be under a licensed pharmacist's immediate and personal supervision at all times

"Immediate and personal supervision"

reasonable visual and vocal distance of the pharmacist

Pharmacist may not supervise more than ___ interns, techs, techs in training at any time

- 8 (NO more than 3 of the 8 may be techs in training)

- If remote dispensing facility also being supervised, ratio changes to 1:6

Licensed pharmacy technician at a remote dispensing facility may be under supervision through use of what?

a computer link, video link, and an audio link

Continuing Education

- Post-licensure professional education

- Obtain through lectures, conferences, seminars, home study

Continuing Education: Contact hour

50-60 minutes = 1 hour continuing education (CE)

Continuing education unit (CEU)

10 contact hours

Continuing education: "Approved by ACPE"

- Pharmacy continuing education providers meet ACPE requirements

- ACPE does not provide or approve CE; it sets requirements for providers to follow

Continuing Education Requirements

- Biennium = January 1 of EVEN numbered years to December 31 of ODD numbered years

- 30 hours (3 CEUs) each biennium

--- At LEAST 4/5 (24) pharmacy practice related

--- MAX of 1/5 of hours (6) business, management computer courses

- At least % of hours from sponsor approved by ACPE

- Cannot carry hours forward, but if fail to meet hours in one biennium, can do extra in next biennium (but only count for past biennium)

CE: Retain certificates for ___ years from end of biennium

4

Additional CE Info

- Report program name, ID number, approved hours to Board at the time of license renewal

- NABP CPE Monitor tracks and stores credits for ACPE-approved activities

- Hours may be transferred from another state if state recognizes Indiana CE hours

CE: Only licensed for part of the biennium

- Earn 1.25 hours for each month (or PART of month)

- If licensed in last 6 months of CE biennium, requirement waived

Indiana CE biennium

January 1 of EVEN years through December 31 of ODD years

Indiana Licensing biennium

July 1 of EVEN years to June 30 of EVEN years

Indiana Unofficial CE "grace period"

January 1- June 30 even years

CE Calculation Practice for 2026-2027 Biennium: First time licensure date: May 31, 2025

30 hours

CE Calculation Practice for 2026-2027 Biennium: First time licensure date: January 20, 2026

30 hours

CE Calculation Practice for 2026-2027 Biennium: First time licensure date: May 20, 2026

25 hours

CE Calculation Practice for 2026-2027 Biennium: First time licensure date: August 21 , 2026

21.25 hours

CE Calculation Practice for 2026-2027 Biennium: First time licensure date: June 30, 2027

8.75 hours

CE Calculation Practice for 2026-2027 Biennium: First time licensure date: July 1, 2027

0 hours

"Impaired pharmacist"

"licensed pharmacist affected by the use or abuse of alcohol or other drugs"

Rehabilitation of Impaired Pharmacists, Confidentiality of Information

- Board may enter into agreements with nonprofits, provide grants to assist pharmacists

- Information is confidential in a program, BUT

--- "Noncompliance" may be used by the board in disciplinary or criminal proceedings

Impaired Pharmacists Account

- Established within state general fund

- Provides money for rehabilitation of impaired pharmacists

- Administered by Indiana Professional Licensing Agency

Places That Require a Pharmacy Permit

A person may not own or operate a location where prescriptions drugs or device are ordered, offered for sale, or paid for unless Indiana pharmacy permit exists (IC 25-26-13-33)

A pharmacy located outside Indiana and dispensing drugs or devices through United States Postal Service or other delivery service to patients in Indiana MUST be registered as what?

a non-resident pharmacy

Pharmacy Permits: Class I

- Retail permit

- Pharmacy provides pharmaceutical care to the general public by the dispensing of drug or device

Pharmacy Permits: Class II

- Institutional permit: hospitals, clinics, health care facilities, sanitariums, nursing homes or dispensaries

- Offer pharmaceutical care by dispensing drug product to an inpatient or outpatient of the institution

Pharmacy Permits: Class III

- Closed door, central fill, mail order, or other operations NOT open to the general public

- Include traditional pharmacy functions

- Or nontraditional functions (infusion, nuclear pharmacy, sterile compounding

Class II hospital or health system may offer drugs or devices to...

- an employee, student, or volunteer of the hospital or hospital system;

- a retiree who is participating in a retirement, pension, or benefit program administered by the hospital or hospital system;

- an independent contractor who has an exclusive relationship with the hospital or hospital system;

- a member of the hospital's or hospital system's governing board; or

- a member of the hospital's or hospital system's medical staff; and

- to dependents of the individuals listed in subdivision (1 ); for their own use.

A pharmacy holding a Category I permit may offer drugs or devices to the following:

- A long-term care facility licensed under or subject to IC 16-28-2.

- A health facility licensed under IC 16-28.

- A housing with services establishment (as defined in IC 12-10- 15-3) registered with the office of the secretary of family and social services.

Pharmacy permits expire when:

every 2 years (biennial)