Central Filling Regulation Law PDF

**Chapter 480-10A CENTRAL FILLING REGULATIONS** For purposes of these Rules and Regulations, the following definitions apply: **Rule 480-10A-.01 Definitions** ----- ----------------------------------------------------- (1) \"Board\" shall mean the Georgia Board of Pharmacy. ----- --------...

**Chapter 480-10A CENTRAL FILLING REGULATIONS** For purposes of these Rules and Regulations, the following definitions apply: **Rule 480-10A-.01 Definitions** ----- ----------------------------------------------------- (1) \"Board\" shall mean the Georgia Board of Pharmacy. ----- ----------------------------------------------------- ----- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- (2) \"Originating Pharmacy\" shall mean the licensed retail pharmacy from which a prescription is physically received and dispensed to the patient or patient\'s caregiver which is outsourcing prescription filling services. This pharmacy shall be the dispensing pharmacy. ----- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (3) \"Central Fill Pharmacy\" shall mean a pharmacy which is permitted by the state in which it is located to prepare prescription orders for dispensing pursuant to a valid prescription transmitted to it by an originating pharmacy and to return the labeled and filled prescriptions to the originating pharmacy for delivery to the ultimate user. ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ **Rule 480-10A-.02 Licensing and Contracting** ----- ------------------------------------------------------------------------------------------------------------------------------ (1) All pharmacies providing central filling services to retail pharmacies in Georgia must be appropriately licensed in Georgia. ----- ------------------------------------------------------------------------------------------------------------------------------ +-----------------------------------+-----------------------------------+ | (2) | A central fill pharmacy shall be | | | deemed \"authorized\" to fill | | | prescriptions on behalf of an | | | originating pharmacy only if the | | | parties have a contractual | | | relationship permitting such | | | activity or share a common owner. | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------ | | | (a) The contract or agreement | | | shall outline the services to be | | | provided and the responsibilitie | | | s and accountabilities of each ph | | | armacy, in relation to such servi | | | ces, in compliance with federal a | | | nd state laws, rules and regulati | | | ons. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------ | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------- | | | (b) Central prescription fill | | | ing of controlled substances requ | | | ires compliance with all Drug Enf | | | orcement Administration (\"DEA\") | | | regulations permitting a central | | | fill pharmacy to fill prescripti | | | ons for controlled substances on | | | behalf of an originating pharmacy | | | as well as state laws, rules and | | | regulations. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------- | +-----------------------------------+-----------------------------------+ ----- -------------------------------------------------------------------------------------------------------------------------------------- (3) The originating and central fill pharmacy shall be jointly responsible for all prescriptions filled utilizing central fill services. ----- -------------------------------------------------------------------------------------------------------------------------------------- **Rule 480-10A-.04 Policies and Procedures** +-----------------------------------+-----------------------------------+ | (1) | A licensed retail pharmacy that | | | desires to provide and/or use | | | central prescription filling | | | services must maintain policies | | | and procedures, which are readily | | | retrievable for submission to the | | | Board or Georgia Drugs and | | | Narcotics Agency (\"GDNA\") upon | | | request. | | | | | | +--------------+--------------+ | | | | (a) | [The | | | | | | policies and | | | | | | procedures | | | | | | must | | | | | | include:]{.u | | | | | | nderline} | | | | | | | | | | | | ---- ----- | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | -------- | | | | | | 1. A cle | | | | | | ar descripti | | | | | | on of the ac | | | | | | tivities in | | | | | | the prescrip | | | | | | tion filling | | | | | | process to | | | | | | be performed | | | | | | by each pha | | | | | | rmacy; | | | | | | ---- ----- | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | -------- | | | | | | | | | | | | ---- ----- | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | - | | | | | | 2. 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An ou | | | | | | tline of the | | | | | | accountabil | | | | | | ities of eac | | | | | | h pharmacy; | | | | | | ---- ----- | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | - | | | | | | | | | | | | ---- ----- | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ---------- | | | | | | 4. A lis | | | | | | t of the nam | | | | | | es, addresse | | | | | | s, telephone | | | | | | numbers, an | | | | | | d all licens | | | | | | e/registrati | | | | | | on numbers f | | | | | | or the pharm | | | | | | acies partic | | | | | | ipating in t | | | | | | he central p | | | | | | rescription | | | | | | filling; | | | | | | ---- ----- | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ------------ | | | | | | ---------- | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 5. | | | | | | Guide | | | | | | lines for: | | | | | | | | | | | | | | | | | | | | | | | | (i) | | | | | | Protecti | | | | | | on of the co | | | | | | nfidentialit | | | | | | y and integr | | | | | | ity of patie | | | | | | nt informati | | | | | | on; | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (ii) | | | | | | Maintena | | | | | | nce of appro | | | | | | priate recor | | | | | | ds to identi | | | | | | fy the names | | | | | | , initials, | | | | | | or identific | | | | | | ation codes | | | | | | and specific | | | | | | activities | | | | | | of each phar | | | | | | macist who p | | | | | | erformed any | | | | | | processing; | | | | | | and | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (iii) | | | | | | Complian | | | | | | ce with all | | | | | | federal and | | | | | | state laws, | | | | | | rules, and r | | | | | | egulations p | | | | | | ertaining to | | | | | | the central | | | | | | filling of | | | | | | prescription | | | | | | s. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | +--------------+--------------+ | +-----------------------------------+-----------------------------------+ **Rule 480-10A-.05 Transmission and Labeling** ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (1) The transmission and labeling of controlled substance prescriptions processed utilizing central fill services must comply with all federal and state laws, rules, and regulations. ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- (2) The originating pharmacy must comply with the minimum required information for the patient record system and all requirements of a prescription drug order as outlined in the Georgia law and Board rules prior to sending a prescription to the central fill pharmacy. ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ----- -------------------------------------------------------------------------------------------------------------------------------------- (3) All prescriptions may be transmitted electronically from an originating pharmacy to a central fill pharmacy including via facsimile. ----- -------------------------------------------------------------------------------------------------------------------------------------- +-----------------------------------+-----------------------------------+ | (4) | [All transmission records must | | | include the | | | following:] | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | (a) \"CENTRAL FILL\" written | | | on the face of a prescription if | | | it is a hard copy prescription, | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | -------------------------- | | | (b) The name, address, teleph | | | one number, Georgia license numbe | | | r, and DEA registration number (i | | | f the prescription is a controlle | | | d substance), of the central fill | | | pharmacy to which the prescripti | | | on has been transmitted, | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | -------------------------- | | | | | | ----- ------------------------- | | | --------------------------------- | | | ---------------------------- | | | (c) Number of refills already | | | dispensed and number of refills | | | remaining (if applicable), | | | ----- ------------------------- | | | --------------------------------- | | | ---------------------------- | | | | | | ----- ------------------------- | | | --------------------------------- | | | -------------------------- | | | (d) The name of the originati | | | ng pharmacy pharmacist transmitti | | | ng the prescription, and | | | ----- ------------------------- | | | --------------------------------- | | | -------------------------- | | | | | | ----- ------------------------- | | | - | | | (e) The date of transmittal. | | | ----- ------------------------- | | | - | +-----------------------------------+-----------------------------------+ ----- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- (5) All receipt of transmission records must include all information included in subsection 4 and the name, address, telephone number, Georgia license number, and DEA registration number (if the prescription is a controlled substance), of the originating pharmacy transmitting the prescription. ----- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- +-----------------------------------+-----------------------------------+ | (6) | [The label affixed to the | | | container of a dangerous drug or | | | other non-controlled substance | | | filled by a central fill pharmacy | | | must contain the | | | following:] | | | | | | ----- ------------------------- | | | (a) Date of fill or refill, | | | ----- ------------------------- | | | | | | ----- ------------------------- | | | --------------------------------- | | | ----- | | | (b) The originating pharmacy | | | name, address, and telephone numb | | | er, | | | ----- ------------------------- | | | --------------------------------- | | | ----- | | | | | | ----- ------------------------- | | | ------------------------ | | | (c) The central fill pharmacy | | | \'s unique identifier, | | | ----- ------------------------- | | | ------------------------ | | | | | | ----- ------------------------- | | | --------------- | | | (d) The serial number of the | | | prescription, | | | ----- ------------------------- | | | --------------- | | | | | | ----- ------------------------- | | | - | | | (e) The name of the patient, | | | ----- ------------------------- | | | - | | | | | | ----- ------------------------- | | | ------------------ | | | (f) The name of the prescribi | | | ng practitioner, | | | ----- ------------------------- | | | ------------------ | | | | | | ----- ------------------------- | | | --------------------- | | | (g) Name of supervising physi | | | cian if applicable, | | | ----- ------------------------- | | | --------------------- | | | | | | ----- ------------------------- | | | ------------------- | | | (h) Expiration date of the di | | | spensed drug, and | | | ----- ------------------------- | | | ------------------- | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------------- | | | (i) The directions for use an | | | d cautionary statements, if any, | | | contained in such prescription or | | | required by law. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------------- | +-----------------------------------+-----------------------------------+ **Rule 480-10A-.06 Information Systems, Record Keeping, and PDMP Compliance** ----- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- (1) The originating and central fill pharmacies must share common electronic files or have appropriate technology to allow secure access to sufficient information necessary or required to process and dispense the prescription. ----- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- (2) The originating pharmacy shall be responsible for maintaining compliance with the Prescription Drug Monitoring Program for all qualifying prescriptions pursuant to O.C.G.A. § [16-13-59](https://public.fastcase.com/9SKwsfNqTc6OieYDhNMyM0Kgf%2bASpltyWMD4UkWv6itp%2bUmo11RdHGo1hSQYZ7zptgLsGs%2fv4AN%2bmp63rGZLZg%3d%3d) including those filled utilizing central fill services. ----- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ----- ---------------------------------------------------------------------------------------------------------------------------------------------------- (3) The record keeping of prescriptions processed utilizing central fill services must comply with all federal and state laws, rules, and regulations. ----- ---------------------------------------------------------------------------------------------------------------------------------------------------- +-----------------------------------+-----------------------------------+ | (4) | The originating pharmacy must | | | have a pharmacist, pharmacy | | | intern, pharmacy extern, or | | | pharmacy technician sign for the | | | receipt of all prescriptions | | | received from the central fill | | | pharmacy. | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------------------- | | | (a) Such receipts must be mai | | | ntained as a part of the prescrip | | | tion record. Receipts shall inclu | | | de the date of receipt, the metho | | | d of delivery (private, common, o | | | r contract carrier) and the name | | | of the originating pharmacy emplo | | | yee accepting delivery. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------------------- | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------- | | | (b) The pharmacist on duty at | | | the originating pharmacy must ve | | | rify the receipt of all controlle | | | d substances. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------- | +-----------------------------------+-----------------------------------+ +-----------------------------------+-----------------------------------+ | (5) | The originating pharmacy is | | | responsible for maintaining | | | records of the processing of all | | | prescriptions entered into their | | | information system including | | | prescriptions filled at a central | | | fill pharmacy. | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------ | | | (a) The information system mu | | | st have the ability to audit the | | | activities of the individuals at | | | the central fill pharmacy filling | | | the originating pharmacy\'s pres | | | criptions. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------ | +-----------------------------------+-----------------------------------+ **Rule 480-10A-.07 Patient Counseling** ----- ------------------------------------------------------------------------------------------------------------------------------------------ (1) It shall be the responsibility of the pharmacist on duty at the originating pharmacy to perform patient counseling of all prescriptions. ----- ------------------------------------------------------------------------------------------------------------------------------------------ ----- ------------------------------------------------------------------------------------------------------- (2) The central fill pharmacy shall not perform patient counseling on behalf of the originating pharmacy. ----- ------------------------------------------------------------------------------------------------------- **Rule 480-10A-.08 Notification to Patients** +-----------------------------------+-----------------------------------+ | (1) | An originating pharmacy that | | | utilizes central filling services | | | must, prior to outsourcing the | | | prescription, notify patients | | | that prescription filing may be | | | outsourced to another pharmacy. | | | | | | ----- ------------------------- | | | --------------------------------- | | | ------------------ | | | (a) The patient shall have th | | | e choice to not have the prescrip | | | tion outsourced. | | | ----- ------------------------- | | | --------------------------------- | | | ------------------ | | | | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------------------ | | | (b) Notification may be provi | | | ded through the use of a sign loc | | | ated in the originating pharmacy | | | which is clearly visible to and r | | | eadable by the public. | | | ----- ------------------------- | | | --------------------------------- | | | --------------------------------- | | | --------------------------------- | | | ------------------------ | +-----------------------------------+-----------------------------------+