070.00.99 Ark. Code R. 007

Current through Register Vol. 49, No. 9, September, 2024

Rule 070.00.99-007 - 04-04: Out of State Pharmacies

04-04: OUT OF STATE PHARMACIES

04-04-0001 -OUT OF STATE PHARMACY REGULATION

Out-of-State Pharmacies shall comply with the following qualifications to be and remain licensed in Arkansas by the Board.

1.

A. The pharmacy holds a current license in good standing in the state(s) in which it is located.

B. Each pharmacist dispensing drugs into Arkansas shall be licensed as a pharmacist in Arkansas or in the state where he practices if that state has standards of licensure at least equivalent to those of Arkansas.

2. A pharmacist licensed in Arkansas shall be named in the application as the pharmacy's pharmacist in charge for the Arkansas permit and as the contact person for communications by the Board. Said Arkansas Pharmacist shall be an employee of the out of state pharmacy who is present at the pharmacy's physical location as stated on the out of state pharmacy permit. The pharmacist in charge for the Arkansas Permit need not be the same person as the pharmacist in charge of the pharmacy pursuant to the law in the state in which the pharmacy is locate.

A. That pharmacist will be responsible for receiving and maintaining publications distributed by the Board.

B. If at anytime the pharmacist so designated as the pharmacist in charge for the Arkansas Permit shall leave the employment of the pharmacy, the pharmacy shall notify the Board within 10 calendar days and designate another Arkansas Licensed Pharmacist to perform this function within 30 calendar days.

3. The Out-of-State Pharmacy shall apply for licensure and renewal on forms approved by the Board. The Board may require such information as reasonably necessary to carry out the provisions of A.C.A. § 17-92-401, including, without limitation, the name, address and position of each officer and director of a corporation or of the owners if the pharmacy is not a corporation.

Provided, however, the Board may grant an exemption from licensing under A.C.A. § 17-92-401 upon application by any nonresident pharmacy which confines its dispensing activity to isolated transactions. In determining whether to grant an exemption, the Board shall consider:

(a) The number of prescriptions dispensed or reasonably expected to be dispensed into Arkansas.

(b) The number of patients served or reasonably expected to be served in Arkansas.

(c) Whether the pharmacy has promoted its services in Arkansas.

(d) Whether the pharmacy has a contract(s) with any employer(s) or organizations) to provide pharmacy services to employees or other beneficiaries in Arkansas.

(e) Medical necessity.

(f) The effect on the health and welfare of persons in Arkansas.

(g) Any other relevant matters.

4. The pharmacy shall pay an annual license fee as defined in Regulation 01-00-0007. When there is a change of Arkansas Licensed Pharmacist in charge, the fee for said change shall be paid as defined in regulation 01-00-0007(13). Final notification, to the Arkansas State Board of Pharmacy, of the new Arkansas Licensed pharmacist in charge shall be on a form furnished by the Arkansas State Board of Pharmacy and accompanied by the fee for said change.

5. The pharmacy shall maintain records of drugs dispensed to Arkansas addresses in such a manner so as to be readily retrievable upon request. Said records shall be made available for inspection by the Board or by Arkansas law enforcement authorities.

6. The pharmacy shall timely respond to any request for information from the Board or law enforcement authorities.

7. The pharmacy shall maintain an incoming toll free telephone number for use by Arkansas customers to be answered by a pharmacist with access to patient records. This service shall be available a minimum of 40 hours a week, six days per week during normal business hours. This telephone number plus others available for use shall be printed on each container of drugs dispensed into Arkansas. The toll free number shall have sufficient extensions to provide reasonable access to incoming callers.

8. Generic drugs shall be dispensed into Arkansas pursuant to the Arkansas Generic Substitution Act; provided, however, nothing herein shall be construed to mandate that an Out-of-State Pharmacy comply with the Arkansas Generic Substitution Act if such compliance would cause the Out-of-State Pharmacy to violate the Generic Substitution Act of the state wherein the facility of the dispensing Out-of-State Pharmacy is located.

9. The facilities and records of the pharmacy shall be subject to inspection by the Board: provided, however, the Board may accept in lieu thereof satisfactory inspection reports by the licensing entity using similar standards of the state where the pharmacy is located.

10. Each Out-of-State Pharmacy doing business in Arkansas by dispensing and delivering or causing to be delivered prescription drugs to Arkansas consumers shall designate a resident agent in Arkansas for service of process.

11. Each Out-of-State Pharmacy doing business in Arkansas shall comply with Board of Pharmacy Regulation # 09-00-0001 (Patient Information, Drug Use Evaluation, and Patient Counseling).

Nothing herein shall be construed to mandate that an Out-of-State Pharmacy comply with Board Regulation # 09-00-0001 if such compliance would cause the Out-of-State Pharmacy to violate law or regulation of the state wherein the facility of the dispensing Out-of-State Pharmacy is located. 10/09/90 (Revised 04/10/92, and 6/23/96, and 8/23/96).

04-04: OUT OF STATE PHARMACIES

04-04-0001 -OUT OF STATE PHARMACY REGULATION

Out-of-State Pharmacies shall comply with the following qualifications to be and remain licensed in Arkansas by the Board.

1.

A. The pharmacy holds a current license in good standing in the state(s) in which it is located.

B. Each pharmacist dispensing drugs into Arkansas shall be licensed as a pharmacist in Arkansas or in the state where he practices if that state has standards of licensure at least equivalent to those of Arkansas.

2. A pharmacist licensed in Arkansas shall be named in the application as the pharmacy's pharmacist in charge for the Arkansas permit and as the contact person for communications by the Board. Said Arkansas Pharmacist shall be an employee of the out of state pharmacy who is present at the pharmacy's physical location as stated on the out of state pharmacy permit. The pharmacist in charge for the Arkansas Permit need not be the same person as the pharmacist in charge of the pharmacy pursuant to the law in the state in which the pharmacy is located.

A. That pharmacist will be responsible for receiving and maintaining publications distributed by the Board.

B. If at anytime the pharmacist so designated as the pharmacist in charge for the Arkansas Permit shall leave the employment of the pharmacy, the pharmacy shall notify the Board within 10 calendar days and designate another Arkansas Licensed pPharmacist to perform this function within 30 calendar days.

3. The Out-of-State Pharmacy shall apply for licensure and renewal on forms approved by the Board. The Board may require such information as reasonably necessary to carry out the provisions of A.C.A. § 17-92-401, including, without limitation, the name, address and position of each officer and director of a corporation or of the owners if the pharmacy is not a corporation.

Provided, however, the Board may grant an exemption from licensing under A.C.A. § 17-92-401 upon application by any nonresident pharmacy which confines its dispensing activity to isolated transactions. In determining whether to grant an exemption, the Board shall consider:

(a) The number of prescriptions dispensed or reasonably expected to be dispensed into Arkansas.

(b) The number of patients served or reasonably expected to be served in Arkansas.

(c) Whether the pharmacy has promoted its services in Arkansas.

(d) Whether the pharmacy has a contract(s) with any employer(s) or organization(s) to provide pharmacy services to employees or other beneficiaries in Arkansas.

(e) Medical necessity.

(f) The effect on the health and welfare of persons in Arkansas.

(g) Any other relevant matters.

4. The pharmacy shall pay an annual license fee as defined in Regulation 01-00-Q007-. When there is a change of Arkansas Licensed Pharmacist in charge, the fee for said change shall be paid as defined in regulation 01-00-0007(13). Final notification, to the Arkansas State Board of Pharmacy, of the new Arkansas Licensed pharmacist in charge shall be on a form furnished by the Arkansas State Board of Pharmacy and accompanied by the fee for said change.

5. The pharmacy shall maintain records of drugs dispensed to Arkansas addresses in such a manner so as to be readily retrievable upon request. Said records shall be made available for inspection by the Board or by Arkansas law enforcement authorities.

6. The pharmacy shall timely respond to any request for information from the Board or law enforcement authorities.

7. The pharmacy shall maintain an incoming toll free telephone number for use by Arkansas customers to be answered by a pharmacist with access to patient records. This service shall be available a minimum of 40 hours a week, six days per week during normal business hours. This telephone number plus others available for use shall be printed on each container of drugs dispensed into Arkansas. The toll free number shall have sufficient extensions to provide reasonable access to incoming callers.

8. Generic drugs shall be dispensed into Arkansas pursuant to the Arkansas Generic Substitution Act; provided, however, nothing herein shall be construed to mandate that an Out-of-State Pharmacy comply with the Arkansas Generic Substitution Act if such compliance would cause the Out-of-State Pharmacy to violate the Generic Substitution Act of the state wherein the facility of the dispensing Out-of-State Pharmacy is located.

9. The facilities and records of the pharmacy shall be subject to inspection by the Board: provided, however, the Board may accept in lieu thereof satisfactory inspection reports by the licensing entity using similar standards of the state where the pharmacy is located.

10. Each Out-of-State Pharmacy doing business in Arkansas by dispensing and delivering or causing to be delivered prescription drugs to Arkansas consumers shall designate a resident agent in Arkansas for service of process.

11. Each Out-of-State Pharmacy doing business in Arkansas shall comply with Board of Pharmacy Regulation # 09-00-0001 (Patient Information, Drug Use Evaluation, and Patient Counseling).

Nothing herein shall be construed to mandate that an Out-of-State Pharmacy comply with Board Regulation # 09-00-0001 if such compliance would cause the Out-of-State Pharmacy to violate law or regulation of the state wherein the facility of the dispensing Out-of-State Pharmacy is located. 10/09/90 (Revised 04/10/92, and 6/23/96, and 8/23/96).

070.00.99 Ark. Code R. 007

11/10/1999