This chapter establishes operational standards for Mental Health pharmacies operating within Alabama's community mental health centers under the Department of Mental Health. It covers staffing requirements (licensed pharmacist), physical facility standards, drug ordering and receiving procedures, storage and security, accounting for the Indigent Drug Program, dispensing requirements, and recordkeeping obligations for controlled substances. Pharmacy operators must comply with both Alabama State Board of Pharmacy requirements and federal DEA regulations, and must notify the Department of any key personnel changes or pharmacy relocations.
View official source580-2-17-.01 Staff (1) Mental Health pharmacies are licensed by the Alabama State Board of Pharmacy and are staffed, either part-time or full-time, by a pharmacist registered in Alabama. (2) The registered pharmacist, as the legally responsible person, shall compound (fill) and/or dispense all prescriptions (Act 205, Sections 8 and 10). Physicians may personally compound and dispense or supply their consumers drugs and medicines for their use (Act 205, Section 32). Such drugs and medicines should be for bona fide emergencies and not exceed a three-day supply. (3) The State office must be advised of any changes in key personnel involved with the Indigent Drug Program, and appropriate in-service training by the Coordinator of Community Pharmacy Services will be available, if needed. (4) Adequate clerical support must be provided to insure that the necessary reports, records, etc., are executed. Authority: Code of Ala. 1975, §46-12. History: Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.02 Facilities (1) Physical requirements: The pharmacy shall: (a) Have adequate floor space (Act 205, Section 16) for dispensing, labeling, and packaging functions, as approved by the State Board of Pharmacy and evidenced by a current Alabama Pharmacy Permit. (b) Have the equipment required by the State Board of Pharmacy for dispensing, issuing, and storing of drugs for administrative functions. (c) Have a sink in any new or renovated facility. (d) Contain reference material as required by the State Board of Pharmacy, and at least one up-to-date text book or reference on clinical psychopharmacology. (e) Provide for a private area for the pharmacist for counseling consumers and/or relatives of consumers on the correct use of medications. (f) Be well lighted and properly secured. (2) Change of location. The Coordinator of Community Pharmacy Services, must be notified of any planned change in the location of a pharmacy. In case of change of address of the center, the following are to be notified when the date of change is final: (a) Alabama State Board of Pharmacy #1 Perimeter Park, South Birmingham, Alabama 35243 (b) Drug Enforcement Administration 900 Western America Circle Mobile, Alabama 36609 (c) Return old Drug Enforcement Order Forms to: Drug Enforcement Administration Registration Branch Central Station Washington, D. C. 20537 (d) Request new Order Form book for new address. This must be done before placing orders for any Schedule II items to be shipped to the new address. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.03 Operating Procedures (1) Ordering Drugs. (a) Drugs will be ordered on a monthly basis. (b) Drug order forms (Form 186 Revised 02-14-91) will be supplied and should be used to order drugs or a center may use a computer generated form that contains the same information. As an alternative to written orders mailed to the Department, orders may be FAXED to the Department. The Department’s FAX number is (334)242-0796. (c) Orders for Schedule II drugs will be ordered on the DEA (Drug Enforcement Administration) 222 order form. (d) Inventory should be maintained in such supply as to cover the anticipated usage between normal drug order intervals. (e) The mental health center director shall sign an assurance that any drugs paid for through the IDP will be used only for persons who meet the clinical and financial eligibility criteria for the IDP. No drugs will be ordered for a mental health center until there is a current assurance statement on file with the Department of Mental Health/Mental Retardation. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.04 Receiving (1) Upon receipt of drugs, each shipment will have two packing slips or invoices. One of the packing slips or invoices must be stamped with a stamp furnished by the Department of Mental Health/Mental Retardation reading "I hereby certify that I have received and checked the items listed above, that they are authorized acquisitions and they are of the kind and quantity noted". The packing slip or invoice must be signed and dated by the pharmacist or other designated staff checking the order. The signed packing slip or invoice must be forwarded to the Coordinator of Community Pharmacy Services within five (5) working days. (2) If an error is found in any drug shipment, the Coordinator of Community Pharmacy Services must be notified immediately. (3) Upon receipt of Schedule II drugs, the copy of the DEA order form will be completed as required by federal law. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.05 Storage (1) All drugs must be stored in a locked room in the absence of the pharmacist. (2) Drugs for the Indigent Drug Program must be kept separate from any other drug stock(s) or any other center supplies. (3) Access to the pharmacy must be limited to the pharmacist and only the Pharmacist shall have keys to the Pharmacy. Pharmacy assistants may be in the pharmacy at the same time as the pharmacist. (4) Drugs can be received only by an authorized representative in the absence of the Pharmacist and must be stored in a place that can be securely locked outside the pharmacy. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.06 Accounting The Examiners of Public Accounts have determined that there should be entries in the general ledger for drugs received and dispensed by each center. The value of the drugs must be included as part of the center's revenues and, when dispensed, as part of the center's expenditures. To accomplish this, the following procedure must be followed: (1) Monthly: (a) The center must determine the monthly value of drugs received from a prime vendor and enter the value of drugs shipped for the month in the general ledger as revenue. (b) As drugs are dispensed, a running total should be kept of the amount dispensed and the value of the drugs, using the price list which is provided. (c) The value of the drugs dispensed to consumers must be entered in the general ledger as an expense at the close of each month. (2) Quarterly: (a) The value of drugs received should be reported as listed in the general ledger through the Quarterly Receipts and Expenditures Statement. The value should be recorded under "Receipts, Alabama Department of Mental Health/Mental Retardation, Indigent Drugs". (b) The value of drugs dispensed to consumers in the general ledger should be reported as an expense. (3) Annually: (a) A physical inventory of drugs on hand should be taken at the close of business September 30 of each year. Determine the value of the drugs on hand, using the prices reflected on the invoices of the prime vendor or those available from the state office. This inventory must be verified by spot checks of selected items by someone designated by the Center Director other than Indigent Drug Program personnel. (b) The value of the drugs on hand must be entered in the general ledger as an asset of the center. (3) Handling of Out-of-Date Drugs. (a) With prior approval by the Coordinator of Community Pharmacy Services, out-of-date drugs are to be surrendered to a company that is approved by the Alabama Department of Mental Health/Mental Retardation, engaged in the practice of obtaining credit for out-of-date drugs that are credit-worthy, and is competent in the destruction of non-credit-worthy drugs. Adjustments to the inventory records must be made and the value of the drugs surrendered must be provided to the center's business office. Documentation of the drugs surrendered should be kept in the pharmacy. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.07 Drug Returns (1) Regarding drugs returned by consumers: "No licensed pharmacist or pharmacy operating within this state shall accept for refund purpose or otherwise any unused portion of any dispensed prescription". (Act 205, Section 16) (2) Contact the Coordinator of Community Pharmacy Services for the procedure before returning drugs to any pharmaceutical company or prime vendor. Authority: Act 205, Section 16. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.08 Drug Theft (1) Any pharmacy involved in the loss of controlled substances must notify the DEA regional office upon discovery of theft or significant loss. The DEA office will furnish a form to be filled out, along with instructions for completing the form. This report will be forwarded to the DEA regional office. Address: Drug Enforcement Administration 234 Goodwin Crest Drive Birmingham, Alabama 35209 Phone: (205) 290-7150 (2) The Alabama State Board of Pharmacy must be notified. Address: Alabama State Board of Pharmacy #1 Perimeter Park, South Birmingham, AL 35243 Phone: (205) 967-0130 (3) Notify the Coordinator of Community Pharmacy Services, State Department of Mental Health and Mental Retardation. Authority: Code of Ala. 1975, §22-50-11. History: Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.09 Dispensing (1) Prescriptions: No drug will be furnished to a consumer unless a legal prescription is available. Prescriptions must be filed in accordance with the requirements under 580-2-17-.09(2), Records. (2) Records: (a) All prescriptions on file, invoices, and records for controlled substances must be maintained for two years in order to comply with state and federal laws. (b) Prescriptions for Schedule II items must be kept in a separate prescription file. (c) All prescriptions for controlled items other than Schedule II items may be kept in a separate file or in the regular file with a red "C" stamped on the bottom right face of each prescription. (d) Medications dispensed should be recorded. (e) A consumer profile must be maintained on all consumers participating in the Indigent Drug Program. The consumer profile must contain all information required by the Alabama State Board of Pharmacy. (3) Other Requirements: (a) Reasonable proof of eligibility for the drug program must be established before filling prescriptions. Exception: One-time only for prescriptions from a state institution, crisis stabilization program or for a documented emergency. (b) A prescription will be limited to five refills, or six months, whichever occurs first, unless the prescribing physician indicates more stringent directions. The quantity issued at any one time will not exceed a thirty-three day supply. (c) Safety closure vials will be used for all prescription drugs in oral dosage form. (d) Appropriate "warning labels" will be used with all medications as determined by the pharmacist. (e) Refills are not permitted unless indicated by the prescribing physician. (f) Prescriptions for controlled drugs must show the prescriber's DEA number and full address of the consumer. These prescriptions must be initialed by the person filling the prescription. Each refilling of a prescription must be entered on the back of the prescription or on another appropriate document and be initialed by the person filling the prescription. Pharmacies using a computerized pharmacy program must generate daily printouts of each day’s controlled drugs activity. This printout must be verified, dated, and signed by each pharmacist who filled these prescriptions. In addition, the pharmacist must initial each prescription on the printout that he/she filled. These printouts must be maintained in a separate file for a period of two (2) years from the dispensing date. A printout must be generated at least weekly of all new and refill prescription activity of the pharmacy for this period. This information must be kept in a separate binder and retained for two (2) years. (g) Schedule II items are not to be refilled under any circumstances. (h) Prescriptions filled in advance for consumers and/or prescriptions filled and not called for must be kept in a secure (locked) place. Access to these prescriptions will be limited to the pharmacist, the Community Mental Health Center Director, and any other person authorized by the Director and agreed upon by the Pharmacist. (i) If a prescription is unclaimed by a consumer and has not been removed from the facility, the drug should be returned to stock. (4) Medication Delivery to Satellites: A Medication Delivery Record shall be filled out in duplicate for all filled prescriptions delivered to locations outside the central center. The record must be signed by the person responsible for delivery and one signed copy kept by the pharmacist. The duplicate copy must accompany the filled prescriptions, be filled out by the person responsible for the care of the prescriptions, and returned to the pharmacist within 60 days of issue with any unissued medication. (5) Mailing Filled Prescriptions: (a) Filled prescriptions may be sent by regular mail, if necessary, but this should be minimized. (b) The following information shall be recorded and maintained in the pharmacy for filled prescriptions which are mailed: 1. Name and address of patient. 2. Prescription number(s). 3. Date mailed. 4. Initials of person mailing medication. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.10 Records (1) Clinical Records. A record of drug therapy will be maintained on all consumers qualified for the Indigent Drug Program. This record must be signed by the prescribing physician. If the prescribing physician is not employed by the center, a statement of diagnosis signed by the physician responsible for treatment must be maintained in the record. In addition, the Medication Chart will be part of the client records. (2) The Controlled Substances Act of 1970: (a) Every pharmacy engaged in handling any controlled substances must keep complete and accurate records of all receiving and dispensing transactions. All such records shall be maintained for a period of two years. (b) All inventories and records of controlled substances in Schedule II must be maintained separately from all other records of the pharmacy. All inventories and records of controlled substances in Schedules III, IV, and V must be maintained separately or must be in such form that they are readily retrievable from the ordinary business records of the pharmacy. (c) All records pertaining to drugs subject to the Controlled Substance Act must be made available for inspection and copying by duly authorized officials of the Drug Enforcement Administration. (d) The pharmacist must take a complete separate inventory of all stocks of drugs subject to the Controlled Substance Act on January 15 of each year. This inventory record must be kept for a period of two years. Pharmacies are not required to submit a copy of the inventory to the Drug Enforcement Administration; however, a copy of this inventory signed by the pharmacist must be kept in the pharmacy. The inventory must show the date taken and whether taken at the opening or closing of business. Authority: Code of Ala. 1975, §22-50-11. History: Amended: Filed March 30, 1993; Effective May 5, 1993. Repealed and Replaced: Filed October 28, 1998; effective December 3, 1998. 580-2-17-.11 Reserved