Alabama pharmacy practice act

state drug inspector
must train under chief inspector for 6 months.
give ALBOP $2000 bond
same restriction as law enforcement for search and seizure
may inspect ANYTHING in pharmacy
bankruptcy sale
must notify board at least 1 week before sale
10 days after sale, must give state board name and addresses of people who who bought drugs
Illegal possession of Rx drugs
misdeamanor, fined up to $1000 and 1 year in jail, not applicable to medical/pharmacists, or couriers
generic drugs
pharmacist may sustitue unless doc says no, pharamicist must record on RX the manufactuere or distributor of products. all writeen rx should have two lines, one or prodcut selection permitted and one is dispense as written.
What is charge for adulteration?
misdameanor
notify board on change of employement?
within 10 days for pharmacists
RN employed by state health dept
may dispense legend drugs under supervision of doctor for tx of TB, STD
penalty for practiicng without license
1000, or 1 year in jail, misdeamonr
pharmacy permits
register biennially, must apply 30 days before opening, msut notify within 10 days change of ownership. IF pharmacist ownder dies, next of kin has 30 days to comply with rules, not prescription may be dispensed during that time
manufactuere, distributor etc.
get permit biennaly 500-2000 initial, 250-1000 for renewal, msut have pharamcist unless wholesale distribuotr. must ensure that they distribute to docs, vets, dentist or pharmacies
when can board suspend license?
felony, violation of drug laws, any crime that reflects inability to job, inability due to illness, inebration, drug abuse, narcotics, alcohol, mental or physical condition. board may designate doctor to evaluate pharamcist, the pahramcist can also get own doctor at his or her own expense. Board must give in writing notic of hearing within 30 days, burden of proof is with the board
pharmacist assistant
practice 15 yaers of pharamcy need afidavit from two licensed pharamcist, then can practice pharmacy under pharmacist. Pharmacist must be on site or available for consulatation at all times
pharmacist application
applicaqtion must be recieved at least 10 days before examination. Can take Naplex 3 times in 3 years, if fail 3rd time must take training approved by board
LIcense by reciprocity
msut take MPJE and interview iwth board
LIcense renewal
Renew on even nubmer years in due OCtober 31st ending Dec 31st. 25-150 dollars. 15 hours of CE per year and 3 must be live
Supervising pharmacies
Pharmacist may only supervise one pharmacy at a time, temp abcenses should be more than 3 hours per day or more than 1.5hours at a time, not more than 1 week for temp illness. the rx dept shall be closed during those times.
LIcesnes
Licensed must be displayed and readable by ghe public
Can you accept returns on meds?
NO
Sale of poisons
Can’t be disp,layed in area allocsted for customer use. can be sold to anyone under 12 or anyone under inluence of alcohol
Pharmacy as a pick up station
Can’t do that unless exempt from the board. these places can deliver meds to their clinics for patient pick up
Prescritpion blank
Can’t have pharmacy name or name and address of any person licensed
Copy
intern or pharmacist only, note on RX that a copy was given with date and whom given to
Prescritpion file
all should be kept for 2 years, must be filed in order of filling with number and date of dispnesing on it.
Prescritopion compouding area
not less than 240 square feet, surface of counter sahl be no less than 24inchesin width and not less than 16 square feet of unobstructed working space for one pharmacist and not less than 24 square feet of total working space where 2 or more pharmacists are to be on duty at one time.The floor occupied by dispensing pharamcist shall estend the full length o the compounding counter and be clear for a minimum of 36 inches
Skilled nursing homes, hospitals etc
If not have a pharmacy that the medicine room must be under the direct supervision of a consultatn pharmaicst of doctor. If not skilled no legend drugs on premisis drugs must be delievered by a licensed pharmacy
Emergency refill
can give 72 hours, cant be C2,med must be essetial to life or chroni condition, pharmaist mus make a written order and tell doctor within 72 hours of dispensing
Board of pharmacy
5 members licensed in this state for at least 5 years. 3 member appointed by governor one in hospitalo, one chaqin and one independent. Every 5 years APA of ASHP sall submit 3 nominees to governor. Ever 5 years the board names a nominating ocmmitte of five pharmacist. Ballots mailed on sept 1, votes due to oct 1. Term begins JAN 1st, ends Dec 31st o fifth year. Can’t be there for 2 consecutive terms. Members have 30 days to take oath. Board names a secretary and they set her pay
Duties o bard members
at leat 3 meetings per year, will get same travel expenses and epr diem as state employess, the baord by also give allowance
New rules
will be electronically sent to each pharmacist 10 days before it goes into effect
board assisting officers
board will assist in prosecuting anyone who violates rules, attorney general will be counsel
Contract with third party
msut say method and amount of reimburseemtn, and frequesncy and a method for compaints or settlements.
Denial of payemnt
thrid party can’t deny payment i illegal use of ID card happened unless pharmacy was notified
Reimbursement rates
Not less than usual and customary rates for cash customers
pharm tech
must be registered, under supervision of pharmacist, pharmacist responsible for action, registere bienally in odd number years, 3 hours CE annually,1 hour live
Compounding
pharmacist shall verify wt and volume of active ingredients
compoudning area
cleanable wall, ceilings, floors, adequate lighting and ventilation. potable water supplied under continuous positive pressure
if componenet trasnferred to another contianer
label must include component name and supplier, lot number and expiration date, strength and concentration
COmpounded prescription made in anticipation of rx
list of ingredients, prep date, bud, storage condition, batch or lot number. must be prepared in reasonable amounts
OTC compounded products
not contain strength that exceeds OTC strenghts. labeled with products name, directions for use, list of active ingredeints, warnings. amhy be sold after consultation with pharmacist. shall be stored in prescription department.
Compound for prescirber
Must have an order, only adminstered in office not dipensed to consumber. Must remain on file for 1 years which includes, name and address of prescriber, date of sale, description and amount of product sold.
Label must have
name and strenght
quantity
date
bud
lot no
name and address of pharmacy
may not include for office use
Equipment in pharmacy
Fact and Comparisons or any other book or electronic media to meet level of pracitice, hto and cold running water, prescritpion balance. Satelelit pharamcies must have all of the above excpet balance. Comminuty pharmacies must have an exempt narcotic register
Prescirption files
all rx must include initials o the person who dispensed as well as prescription number and date it was dispensed
absense of pharmacist over assistant
Must leave sign giving pharmacist name and address, telephone number and hours he will be away. must be able to return to store within 30 minutes
agent of record
mail order pharmacy not in state must appoint agent of record who is resident of alabama, if no the n the secretary o state o alabama
condition of registration for mail order
registerd, keep records, maintain hours tha tpermit timely dispensing of drugs to alabama patients and provide reasonable access to alabama patient ot consult wiht licesnsed pharmacist, provide toll free number for patints to call and must put on drug container
policy and procedure for mail order
normal delivery times, procedure if patients med is not available, procedure for rx for acute illness, procedure for interim doses
complaints for mial order
will go to that stae which the pharmacy is in, if that board does not resolve claim in 45 days, albop will do it
pharmacist consultant
register initially and annually with board. Need 6 hours at least 2 should be consultatn recertification. After 1996, must take a 10 hour course with a score of 75 on exam
training for preceptors
at least 2 years, training seminar at least once every 3 years
Interns
Must reprot place o emplyment within 10 days
pharmacy keys
owner of pharmacy may designate one unregistered person to have a key, must send copy to bop, may also give eky to emergency fire personnel must send copy to albop
Supervising pharmacist
Must be onsite at least 50% of time or 30 hours per week whichever is less.Must notify board within 10 days of change of suervising pharmacist position. Must take controlled inventory within 15 days. Pharmacy must notify board if not have a supervising pharmacist and must get one within 90 days
Prescription labels
name and address of pharmacy, directions for use, name,strength per dosage unit. Prescirber’s mixture may be used if no name and lal ingredients can’t fit on label. The drug name and strength may be omitted on request of docotr.
Technicians role
3 per pharmacist, one lcertified. must be 17, can’t document receipt of controlled substance inventory. $10.00 penalty for each lapsed year up to 5 years then must reinstate
C3-C5 refills
printout of refills msut be signed within 72 hours or maintain a bound log book. If ocmputer has downtime must hve procedures to document history.
training
1500 hours, 400 traditional, minumum 4 hours per week and nor more than 40 hours.week. Perceptor can only supervise 3 interns at one time.
absence of pharmacist in institutional setting
arrangements should be made for access by locked cabinet or enclosure. A pharmacist shall be available after hours
Locked cabinet requirements
inventory listing, only prepackage drugs, ammounts sufficient for immediate therapeutic requirements, inventory every 30 days, audit on activity no less than once per month. in case of emergency one supervisory nurse or physician can obtain drugs from pharmacy
If institution has no pharmacy
can have emegency kit supplied by pharmacist, label must contain drugs, drug strenth, quantity, exp daqte of contents, name, address, phone number of pharmacist. When used the pharmacist must restock wihtin 72 hours.
stat cabinrt
noncontrolled drugs needed to effectively manage pt condition which are not availabe from another source in sufficinet time. faciity may only have one, if want more than one must be approved by board
number of drugs provided by pharmacy to long term care
no more than 50, not to exceed 48 hour supply
parenteral pharmacy
msut be registerd
parenteral pharmacist
msut take class at least 5 hours didactic and hands on , must also have witten exam
compounding of parenteral area
certified laminar air flow hood with intact HEPA filter, cleanable surfaces walls and floors, hood certified annually. Mut have a fridge and freezer
Labelin for parenteral products
phone number o pharamcy if administered outside of pharamcy. name and strength including primary solution, instruction for storage and handling, proper disposal for cytotoxic agents
recordkeeping for parenterals
records of furnishing meds, pt name,sex,age,address,phone number, primary dx, summary of most recent hospitalization, med histroy, allergies
nuclear pharmacy
pharmacy must register annually, pharmacist must be certified 1 hour of CE annually related to nuclar pharmacy
labelin for nuclear materials
radiation symbol, “caution:radioactive material”, name of procedure, rx #,lot#, radionuclide and chemical form, amount of radioactivity and calibration date and time, expirtion date nad time, volume dispened, molybdenum-99 to USP limits, name of pt or word “physician use only”
inner container of nuclear
radiation symbol, caution:radioacctive material, radionuclide, chemical form, name of procedure, rx#
equipemnt
fume hood, radiotion containemnt drawing section, dose calibratory, well scintillation counter, area rate meters, geiger-mueller survery meters, fridge, microscope, hemocytometer, leaded glass syringe and vial shileds, personnel radiation detection devices, radiactive storage container
supplies
syringes, vials required to perform, disposable gloves, lab coaats supplies for aseptic technique, supplies for TLC, leaqd transport shileds, DOT type 7A transport containers
nuclear pharmacist training
200 hours ofclassroom, 500 hours internship
patient counseling
offered on new rx
all new rx and refill reviewed for
dup, DDI, drug-disease, incorrect dosage/duration, durg allergy, clinical abuse/msiuse
wholesaler conditions
free of vermin, stored according to manufactureer, if not specified must be under controlled conditions in the compendium, separate area for expired meds
wholesaler secuirty
alarm system after hours, adequate lighting outisde, msut have procedures to prevent internal theft
exam of drugs
all drugs must be inspectd upon arrival and departure
wholesaler recordkeeping
source of drugs including name and address of seller or trasnferror and address to where shipment went, identity and quantity of drugs recieved and distributed or disposed of and dates of receipt and distirubtion or disposition of drugs. KEPT for 2 years
records at central location
records may be kept a central location, but must be made accessible within 2 working days
charge back transactions
must be kept separately
Written Policies and Procedures
A procedure to ensure that wholesale drug distributors prepares for, protect against, and
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handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster or any other situation of local, state, or national emergency.
(ii) A procedure to ensure that any outdated drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of the outdated drugs and shall be maintained for two (2) years after the disposition of the same.
(iii) A procedure whereby the oldest approved stock of a drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.
(iv) A procedure to be followed for handling recalls and withdrawals of drugs which shall be adequate to deal with recalls and withdrawals due to:
(I) Any action initiated at the request of the Food and Drug Administration or other Federal, State or Municipal law enforcement or other governmental agency, including the Alabama State Board of Pharmacy.
(II) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or
(III) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.
(h) Returned, Damaged and Outdated Drugs
Returned, Damaged and Outdated Drugs:
Any drug that is outdated, damaged, deteriorated, misbranded or adulterated shall be quarantined and physically separated from other drugs until destroyed or returned to the supplier.
2. Any drug whose immediate or sealed outer or secondary container has been opened or used shall be identified as such, and shall be quarantined and physically separated from other drugs until destroyed or returned to the supplier.
3. If the conditions under which a drug has been returned casts doubt on the drug’s safety, identity, strength, quality, or purity, then the drug shall be destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity.
(I) In determining whether the conditions under which a drug has been returned casts doubt on the drug’s safety, identity, strength, quality, or purity, then the wholesale distributor shall consider, among other things, the conditions under which the drug has been held, stored or shipped before or during its return and the condition of the drug and its container, carton or labeling as a result of storage or shipping
Responsibility for Operation:
A wholesale drug distribution operation should maintain a list of principals and persons in charge (including officers, directors, or primary stockholders) including a list of their duties and their qualifications.
2. All applicants for a permit as a controlled substance wholesale drug distributor must be registered with the Board of Pharmacy and with the U.S. Drug Enforcement Administration and comply with all DEA regulations.
3. The Board of Pharmacy shall consider, at a minimum, the following factors in reviewing the qualifications of those persons who engage in the wholesale distribution of drugs within Alabama:
(i) Any convictions of the applicant under any Federal, State, or Municipal laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;
(ii) Any felony convictions of the applicant under Federal, State, or Municipal laws;
(iii) The applicant’s past experience in the manufacturing or distribution of drugs, including controlled substances;
(iv) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;
(v) Suspension or revocation by Federal, State or Municipal government of any license currently or previously held by the applicant for the manufacturing or
distribution of any drugs, including controlled substances;
(vi) Compliance with licensing requirements under previously granted licenses, if any;
(vii) Compliance with the requirements to maintain and/or make available to the State licensing authority or to Federal, State, or Municipal law enforcement officials those records required to be maintained by wholesale drug distributors; and
(viii) Any other factors or qualifications the Board of Pharmacy considers relevant to and consistent
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with public health and safety.
4. The Board of Pharmacy reserves the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest.
(
personnel
The Alabama State Board of Pharmacy shall require that personnel employed in wholesale distribution have appropriate education and/or experience to assume responsibility for positions related to compliance with State licensing requirements
Violations:
It shall be a violation of these rules for a wholesale drug distributor to distribute legend drugs directly to an employee, consumer, or a patient, or to operate in such a manner as to endanger the public health.
2. Conviction of any Federal, State or Municipal drug laws or regulations or violation of any provisions of this Rule may be grounds for the revocation, suspension, probation or refusal to issue the permit granted to wholesale drug distributors by the Board of Pharmacy and/or the imposition of a fine not to exceed the sum of $1,000.00 for each such conviction or violation.
3. Wholesale drug distributors shall operate in compliance with applicable Federal, State and Municipal laws and regulations.
Author: Vance L.
LISTED PRECURSOR CHEMICALS:
All substances listed as precursor chemicals in any regulation set forth in the Code of Federal Regulations shall be considered and designated as a precursor chemical with the exception of those precursor chemicals designated or deleted as such under federal law to which the Board objects, after notice, in the manner provided in Code of Alabama (1975), § 20-2-181(c), all precursor chemicals listed in any federal regulation shall be considered and designated as precursor chemicals pursuant to the provisions of Code of Alabama (1975), § 20-2-180, et seq
LICENSE.
Beginning in 2011 and every two years thereafter, any individual, corporation, partnership, association or other entity who is a manufacturer, wholesaler, retailer or other person who sells, transfers, manufactures, purchases for resale or otherwise furnishes any listed precursor chemicals as defined or designated by any federal or state law or rule must obtain a license. The license shall be issued only after the filing of an application with the Alabama State Board of Pharmacy and Board approval. The application shall contain information as required by and in conformity with any applicable federal or state law or rule.
(b) A biennial license fee in the aA permit must be obtained from the Alabama State Board of Pharmacy each time any individual, corporation, partnership, association or other entity having a legitimate need for using any listed precursor chemical as defined or designated by law or rule of the Alabama State Board of Pharmacy obtains such chemical(s). The permit shall be issued only after the filing of an application with the Alabama State
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Board of Pharmacy and the Board’s approval of that application. The application shall contain information as required by and conform with the requirements of all applicable laws or rules of the Alabama State Board of Pharmacy.
(b) A permit fee in the amount of $35.00 shall be paid to the Alabama State Board of Pharmacy each time any individual, corporation, partnership, association or other entity obtains any listed precursor chemical.
Author:mount of $500.00 shall be paid by all licensees to the Alabama State Board of Pharmacy by December 31 of any even numbered year. If not received by December 31, but is received in the Board’s office no later than January 31 of the following year, a non-disciplinary administrative penalty of fifty percent (50%) of the prevailing renewal fee must be paid by January 31 of the following year in order to renew. This penalty shall be in addition to the prevailing renewal fee
PERMIT
A permit must be obtained from the Alabama State Board of Pharmacy each time any individual, corporation, partnership, association or other entity having a legitimate need for using any listed precursor chemical as defined or designated by law or rule of the Alabama State Board of Pharmacy obtains such chemical(s). The permit shall be issued only after the filing of an application with the Alabama State
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Board of Pharmacy and the Board’s approval of that application. The application shall contain information as required by and conform with the requirements of all applicable laws or rules of the Alabama State Board of Pharmacy.
(b) A permit fee in the amount of $35.00 shall be paid to the Alabama State Board of Pharmacy each time any individual, corporation, partnership, association or other entity obtains any listed precursor chemical.
Author:
DRUG MANUFACTURERS; WHOLESALE DRUG DISTRIBUTORS; PERMIT FEES.
PERMIT.
(a) A biennial permit must be obtained from the Alabama State Board of Pharmacy by any manufacturer bottler, packager, repackager, or wholesale drug distributor of medicines, chemicals or poisons for medicinal purposes. The permit shall be issued only after the filing of an application on a form furnished by the Alabama State Board of Pharmacy and the Board’s approval of that application. The application shall be accompanied by the fee set forth in paragraph (b). The application shall contain information as required by and conform with the requirements of all applicable laws or rules of the Alabama State Board of Pharmacy.
(b) The fee for the biennial permit shall be in the amount of $500.00. The fee for any renewal permit shall be in the amount of $500.00. The fee to transfer ownership of the permit shall be in the amount of $250.00.
(c) All permits issued by the Alabama State Board of Pharmacy shall become due on October 31 and shall become null and void on December 31 of even-numbered years. Each application for the renewal of the permit shall be made on or before December 31 of even-numbered years, at which time the previous permit shall become null and void. A penalty of twenty-five dollars ($25.00) for each overdue month shall be assessed in addition to the permit fee for renewal of delinquent permits.
Author: Jerry Moore, R.Ph, J.D., Executive Director
Statutory Authority:
EMERGENCY PRESCRIPTION REFILL
If a pharmacist received a request for a prescription refill, the original of which is maintained in the pharmacy files, and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a 72 hour supply of the prescribed medication, provided that:
(a) The prescription is not a medicinal agent listed in Schedule II appearing in Title 20 Chapter 2.
(b) The prescription is not a medicinal agent listed in Schedule III appearing in Title 20 Chapter 2.
(c) The medication is essential to the maintenance of life or the continuation of therapy in a chronic condition including but not limited to drugs listed in the following categories, according to the latest edition of Facts and Comparisons, U.S.P./N.F., P.D.R. or A.M.A. Drug evaluation
PRIVATE CONSULTATION AREAS for PHARMACIES
Since the implementation of patient consultation requirements as a result of OBRA ’90 guidelines, it has become evident that the current setup in pharmacies is not conducive to proper communication with patients by pharmacists. Research shows that private consultation areas will facilitate proper consultation with patients by pharmacists and the resultant patient outcomes will be enhanced. Therefore, in order to protect the health of the public and enhance their medication outcomes, private consultation areas must be furnished by pharmacy owners.
(2) The size of the consultation area must be large enough to accommodate the participants and must be entirely devoted to enhancing patient outcomes and not a storage room for merchandise or other non-related items. The area must be accessible by the patient from outside of the pharmacy area without having to traverse a stock room or pharmacy area and must have the capability of being private to both sounds and viewing by unauthorized parties. The area must be away from checkout areas and flows of traffic that would present a barrier to patient communication.
(3) All new pharmacies that open after January 1, 1997, must be in compliance before a permit is issued. All pharmacies that are relocated after January 1, 1997, shall be in compliance. All existing pharmacies must be in compliance on or before January 1, 2005.
TEMPORARY ABSENCES OF PHARMACISTS DURING BREAK AND MEAL PERIOD
This rule is to allow pharmacists to have breaks and meal periods without unreasonably impairing the ability of a pharmacy to remain open.
(2) In any pharmacy that is staffed by a single pharmacist, the pharmacist may leave the pharmacy area or department, temporarily, for breaks and meal periods without closing the pharmacy and removing interns/externs and technicians from the pharmacy, if the pharmacist reasonably believes that the security of the controlled substances will be maintained in his or her absence.
(a) If, in the professional judgment of the pharmacist, the pharmacist determines that the pharmacy should be closed during his or her absence, then the pharmacist shall close the pharmacy area or department and remove all interns/externs and technicians from the pharmacy during his or her absence.
(3) During the pharmacist’s temporary absence, no prescription medication may be provided to a patient or to a patient’s agent unless the prescription medication is a new or refill medication that the pharmacist has checked, released for furnishing to the patient and was determined not to require the consultation of a pharmacist.
(4) During such times that the pharmacist is temporarily absent from the pharmacy area or department, the interns/externs and technicians may continue to perform the non-discretionary duties authorized to them by any applicable law or rule. However, any duty performed by an intern/extern or technician shall be reviewed by a pharmacist upon his or her return to the pharmacy.
(5) The temporary absence authorized by this rule shall be limited to thirty (30) minutes. The pharmacist shall remain within the facility during the break period and be available to handle all emergency situations.
(6) The pharmacy shall have written policies and procedures regarding the operations of the pharmacy area or department during the temporary absence of the pharmacist for breaks and meal periods. The policies and procedures shall include the authorized duties of interns/externs and technicians, the pharmacist’s responsibility for maintaining the security of the pharmacy. The policies and procedures shall be
SCORE TRANSFER
The board may issue a license without an additional North American Pharmacist Licensure Examination (NAPLEX) if, at the time the examination is taken, the applicant designates that the score is to be transferred to Alabama. The applicant is then required to take the Alabama MultiState Pharmacy Jurisprudence Exam (MPJE), obtain an average of 75 and participate in an oral interview conducted by the Board. He or she shall furnish satisfactory proof that he or she holds a professional degree from a division, school, college or a university department of pharmacy recognized by the State Board of Pharmacy. The state from which the score is being transferred must accept a score transfer from the State of Alabama.
(2) The application must be accompanied by a fee of $300.00.
CENTRAL PRESCRIPTION FILLING
Purpose. The purpose of this section is to provide standards for centralized prescription filling by a retail pharmacy.
(2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act.
(a) ACT. The Code Alabama 1975, Title 34 Chapter 23, Practice of Pharmacy Act 205 and The Code of Alabama 1975, Title 20 Chapter 2, Alabama Uniform Controlled Substances Act 1407.
(b) CENTRAL PRESCRIPTION FILLING. The filling of a new or refilling of a prescription drug order by one pharmacy licensed by the Alabama State Board of Pharmacy at the request of another pharmacy licensed by the Alabama State Board of Pharmacy for delivery to the patient or patient’s agent, pursuant to the lawful order of a practitioner.
(c) DISPENSE. To sell, distribute, administer, leave with, give away, dispose of, deliver, or supply a drug or medicine to the ultimate user or their agent.
(3) Operational standards.
(a) General requirements.
1. A retail pharmacy may outsource a prescription drug order filling to another retail pharmacy provided the pharmacies:
(i) Have the same owner; or
(ii) Have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and
(iii) Share a common electronic file or have appropriate technology or interface to allow access to sufficient information necessary or required to fill or process a prescription drug order.
(2) The supervising pharmacist of the filling pharmacy shall assure that:
(i) The pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process; and
(ii) The filled prescriptions are shipped in containers, which are sealed in a manner as to show evidence of opening or tampering.
(iv) The filling pharmacy shall comply with the provisions of the Code of Alabama 1975, Title 34
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Chapter 23, Practice of Pharmacy Act 205 and the Code of Alabama 1975, Title 20 Chapter 2, Alabama Uniform Controlled Substances Act 1407.
3. Any filled prescription, which was not picked up, must be put into the dispensing pharmacy’s inventory.
4. No licensed pharmacist or central fill pharmacy operating within this state shall accept for refund purposes or otherwise any unused portion of any filled prescription.
5. Schedule I & II drugs may not be centrally filled.
(4) Notification to patients. A pharmacy that outsources prescription filling to another pharmacy shall:
(a) Prior to outsourcing their prescription:
1. Notify patients that their prescription may be outsourced to another pharmacy;
2. Give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may fill the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.
(5) Prescription Labeling. The filling pharmacy shall:
(a) Place on the prescription label a ‘Unique Identifier’ of the pharmacy filling the prescription and name and address of the pharmacy that dispenses the filled prescription.
(b) Indicate in some manner which pharmacy filled the prescription (e.g., “Filled by ABC Pharmacy for XYZ Pharmacy”); and
(c) Comply with all other labeling requirements of federal and state statutes.
(6) Records:
(a) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
1. The records maintained in the alternative system contain all the information required on the manual record; and
2. The State Board of Pharmacy and its drug inspectors shall enforce all provisions of this rule. Prescriptions, orders and records required by this chapter and stocks of controlled substances enumerated in Schedules I, II, III, IV, and V shall be open for inspection only to federal, state, county and municipal officers whose duty it is to enforce the laws of this state or of the United States relating to controlled substances. No officer having knowledge by virtue of his/her office of any such prescription, order or record shall divulge such knowledge, except in connection with a prosecution or proceeding in court or before a licensing board or officer, to which prosecution or proceeding the person to whom such prescriptions, orders or records relate is a party.
3. Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions filled or dispensed by the pharmacy.
4. The dispensing pharmacy shall maintain records which indicate the date:
(i) The request for filling was transmitted to the filling pharmacy; and
(ii) The filled prescription was received by the dispensing pharmacy and the name of the person accepting delivery.
5. The filling pharmacy shall maintain records which:
(i) Track the prescription drug order during each step in the filling process and identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any portion of the process including, transmission, filling, dispensing, or delivery; and
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(I) Records which indicate;
(II) The date the prescription was shipped to the dispensing pharmacy;
(III) The name and address where the prescription was shipped; and
(IV) The method of delivery (e.g., private, common, or contract carrier).
(7) Policies and Procedures. A policy and procedure manual as it relates to centralized filling shall be maintained at both the filling and dispensing pharmacies and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy’s operations. The manual shall:
(a) Outline the responsibilities of each of the filling and dispensing pharmacies;
(b) Include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription filling; and
(c) Include policies and procedures for:
1. Notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription filling and the name of that pharmacy;
2. Protecting the confidentiality and integrity of patient information;
3. Dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;
4. Complying with federal and state laws and regulations;
5. Operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.
6. Annually reviewing the written policies and procedures and documenting such review
PRESCRIPTIONS BY ELECTRONIC MEANS.
The following requirements shall apply to any prescription, as that term is defined in Code of Alabama (1975) §34-23-1(21), for non-controlled legend drugs transmitted by electronic means.
(a) The prescription must include the patient’s name and address, the drug prescribed, strength per dosage unit, directions for use, and the name of the prescriber or authorized agent. To the extent not include above, the prescription must comply with any applicable provisions of the Alabama Pharmacy Practice Act or Board Rule now existing or later amended or changed.
(b) Prescriptions may be transmitted directly to the pharmacy or transmitted over an e-prescription network approved by the Board. All such transmissions must ensure appropriate security and authenticity to include the following:
1. An electronic signature process enabling the pharmacy to ensure the identity of the prescriber;
2. Date and time stamp;Transmitting system identifier;
4. Prescriber internal sender identification; and
5. Pharmacy internal receiver identification.
(c) Any pharmacy receiving a prescription shall comply with all requirements for record keeping and prescription information mandated by the provisions of the Alabama Pharmacy Practice Act or Board Rule now existing or later amended or changed except that for the purpose of the substitution of drugs or brands of drugs as set forth in Code of Alabama (1975) §34-23-8, a prescription transmitted by electronic means shall not be considered a written prescription.
(d) Prescriptions for controlled substances, whether scheduled pursuant to state or federal law shall not be authorized until the Drug Enforcement Agency has adopted applicable regulations, at which time all prescriptions for controlled substances must comply with the provisions of any such regulation or any later amendments or changes thereto.
Author: James S. Ward
Statutory Authority: Code of Alabama 1975, §
REGULATION OF DAILY OPERATING HOURS
Any person who receives a community pharmacy permit pursuant to §34-23-30, and commences to operate such an establishment shall, for the benefit of the public health and welfare, keep the prescription department of the establishment open for a minimum of twenty (20) hours per week. A sign in block letters not less than one inch in height shall be displayed either at the main entrance of the establishment or at or near the place where prescriptions are dispensed in a prominent place that is in clear and unobstructed view. Such sign shall state the hours the prescription department is open each day.
INTERNET PHARMACIES
A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner. A pharmacist shall not dispense a prescription drug if the pharmacist has knowledge, or reasonably should have known under the circumstances, that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.
Author: James S.
CONTINUING EDUCATION for PHARMACISTS.
Pharmacists shall complete fifteen (15) hours of continuing education every year as a condition of licensure renewal. By submitting the biennial renewal, a pharmacist is representing their compliance with this requirement by the end of the relevant calendar year.
(2) In order to receive credit for continuing education, the continuing education shall be previously approved by the Board. Any requests for approval of continuing education shall be submitted to the Board no less than thirty (30) calendar days prior to offering of the continuing education. A condition of approval shall be that the continuing education is pertinent to the practice of pharmacy. However, this requirement shall not apply to ACPE approved continuing education courses for which a program number is available
(3) Continuing Education may be completed by either attendance or by distance based program, video or by publications; however, a pharmacist must complete at least three (3) hours of live continuing education through attendance at a course(s).
(4) It is the responsibility of each pharmacist to maintain and compile accurate records relating to all continuing education courses or activities they have attended and completed. It shall be the responsibility of each pharmacist to maintain above described documentation and information pertaining to each year for a period of two (2) years and this information shall be submitted to the Board of Pharmacy within thirty (30) calendar days after a request for the same by the Board.
(5) The Board of Pharmacy shall randomly audit the continuing education documentation or information to be maintained or submitted by each pharmacist as described herein to assure compliance with these rules. Failure to maintain the documentation or information set forth in these rules or the submission of false or misleading information or documentation to the Board of Pharmacy or failure to submit requested documentation or information within the time specified by the Board may subject the pharmacist, after hearing, to those penalties outlined in Code of Alabama 1975 §34-23-33.
(6) Upon written request to the Board of Pharmacy, and upon the demonstration of good and sufficient cause, the Board of Pharmacy may grant a waiver or extension of time for the completion of the annual hour requirements for continuing education as set forth herein. The pharmacist who seeks such a waiver or extension shall submit to the Board of Pharmacy any documentation required by the Board which the Board deems appropriate for it to make a decision concerning that waiver or extension.
(7) Any pharmacist who allows their license to lapse for a minimum of one (1) calendar year but not more than five (5) calendar years, shall be required as a condition for reinstatement to provide documentation of their completion of fifteen (15) hours of continuing education in the manner prescribed above for each lapsed calendar year. If a license is lapsed for more than five (5) calendar years, in addition to the examination requirement set forth in Code of Alabama 1975 §34-23-52, the Board may require as a condition for reinstatement any amount of continuing education deemed appropriate.
(8) A pharmacist may carry over and receive credit for twelve (12) hours of continuing education in the succeeding calendar year; however, a pharmacist must obtain in each calendar year no less than three (3) hours live by attendance. For purposes of this rule, att
CONTINUING EDUCATION for PHARMACY TECHNICIANS.
Pharmacy Technicians shall complete three (3) hours of continuing education every year as a condition of registration renewal. By submitting the biennial renewal, a pharmacy technician is representing their compliance with this requirement by the end of the relevant calendar year.
(2) In order to receive credit for continuing education, the continuing education shall be previously approved by the Board. Any requests for approval of continuing education shall be submitted to the Board no less than thirty (30) calendar days prior to offering of the continuing education. A condition of approval shall be that the continuing education is pertinent to the practice of pharmacy. However, this requirement shall not apply to ACPE approved continuing education courses for which a program number is available
(3) Continuing Education may be completed by either attendance or by distance based program, video or by publications; however, a pharmacy technician must complete at least one (1) hour of live continuing education through attendance at a course(s).
(4) It is the responsibility of each pharmacy technician to maintain and compile accurate records relating to all continuing education courses or activities they have attended and completed. It shall be the responsibility of each pharmacy technician to maintain above described documentation and information pertaining to each year for a period of two (2) years and this information shall be submitted to the Board of Pharmacy within thirty (30) calendar days after a request for the same by the Board.
(5) The Board of Pharmacy shall randomly audit the continuing education documentation or information to be maintained or submitted by each pharmacy technician as described herein to assure compliance with these rules. Failure to maintain the documentation or information set forth in these rules or the submission of false or misleading information or documentation to the Board of Pharmacy or failure to submit requested documentation or information within the time specified by the Board may subject the pharmacy technician, after hearing, to those penalties outlined in Code of Alabama 1975 §34-23-132.
(6) Upon written request to the Board of Pharmacy, and upon the demonstration of good and sufficient cause, the Board of Pharmacy may grant a waiver or extension of time for the completion of the annual hour requirements for continuing education as set forth herein. The pharmacy technician who seeks such a waiver or extension shall submit to the Board of Pharmacy any documentation required by the Board which the Board deems appropriate for it to make a decision concerning that waiver or
LICENSURE OF GRADUATES OF FOREIGN SCHOOLS OF PHARMACY
In addition to complying with all requirements of the Alabama Pharmacy Practice Act relating to licensure, any applicant for pharmacist licensure who is a graduate of a foreign school or college of pharmacy shall comply with the following:
(a) Must successfully obtain and provide to the Board a copy of the Foreign Pharmacy graduate Equivalency Committee Certification.
(b) Must pass a written examination on the laws governing the practice of pharmacy in this state.
(c) Must complete a practical training program as specified in Code of Alabama 1975, Title 34 Chapter 23, Practice of Pharmacy Act 205, §34-23-53 and Board of Pharmacy Rule 680-X-2-.16.
(d) Must demonstrate to the Board the ability to effectively communicate in the English language. In making this assessment, the Board will consider written application materials, oral communication during the interview process and other materials or communications provided by the applicant.
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(2) All provisions of the Alabama Pharmacy Practice Act relating to reciprocity shall apply to foreign graduates who possess a license to practice pharmacy in another state
NON HOSPITAL PHARMACY OFF SITE ORDER ENTRY
The purpose of this Rule is to provide Alabama standards for remote or off-site order entry in any non-hospital pharmacy to which a permit has been issued by the Alabama State Board of Pharmacy (“the Board”).
(2) Definitions
(a) “Off-site order entry pharmacy” means a non hospital pharmacy (“pharmacy”) which has a valid permit issued by the Board to process legend and controlled substance prescriptions that remotely accesses another pharmacy’s electronic data base from outside the pharmacy in order to process prescription drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records.
(b) “Off-site order entry” does not include the dispensing of a prescription drug order but includes any of the following:
1. Interpreting or clarifying prescription drug orders;
2. Data entering and transferring of prescription drug order information;
3. Performing drug regimen review;
4. Obtaining refill and substitution authorizations;
5. Performing therapeutic interventions; and
6. Providing clinical drug information concerning a patient’s prescription.
(c) “Drug regimen review” means an evaluation of prescription drug orders and patient profile records for:
1. Known allergies;
2. Rational therapy-contraindications;
3. Reasonable dose and route of administration;
4. Reasonable directions for use;
5. Duplication of therapy;
6. Drug-drug interactions;
7. Drug-food interactions;
8. Proper utilization, including over-utilization or under-utilization.
(3) The Board may approve a request for off-site order entry based on a presentation before the Board.
(4) The supervising pharmacist or the permit holder of the pharmacy shall submit a written request for off-site order entry a minimum of 30 days prior to the Board meeting at which the pharmacy seeks Board approval.
(a) The request shall be accompanied by a policy and procedure manual for off-site order entry which shall be maintained at all pharmacies involved in off-site order entry and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy’s operations. The manual shall:
1. Outline the responsibilities of each of the pharmacies;
2. Include a list of the name, address, and telephone numbers of the pharmacies involved in off-site prescription order entry; and
3. Include policies and procedures for:
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(i) Patient confidentiality and full compliance with HIPAA requirements;
(ii) Maintenance of appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing and the store it was processed in;
(iii) Mechanism for tracking the prescription drug order during each step of the dispensing process;
4. Specify that a pharmacist holding a current license in good standing or a pharmacy technician working under the direct supervision of a pharmacist shall enter prescription drug orders at a location that is a duly licensed pharmacy.
5. Comply with federal and state laws and regulations; and
6. Include procedures for annually reviewing the written policies and procedures for needed modification with documentation of such review.
(5) General requirements.
(a) A Pharmacy may utilize the services of an off-site order entry pharmacy provided the pharmacies:
1. Share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function; and have;
2. The same owner; or
3. Entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations.
(6) All pharmacies involved in off-site order entry approved by the Board shall comply with all applicable provisions of the Alabama Pharmacy Practice Act and/or Board Rule. Nothing in this Rule shall expand allowable duties of pharmacy technicians as set forth in Board Rule 680-X-2.14.
(7) Off-site order entry may only be performed by pharmacies to whom a permit has been issued by the Board and which permit is in good standing.
(8) Notifications to patients.
(a) A pharmacy that outsources off-site prescription order entry to another pharmacy shall prior to outsourcing their prescription:
1. Notify patients that prescription processing may be outsourced to another pharmacy; and
2. Give the name of that pharmacy; or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may process the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.
(9) Records.
(a) All pharmacies shall maintain appropriate records, which identify, by prescription drug order, the name(s), initials or identification code(s) of each pharmacist or pharmacy technician who performs a processing function for a prescription drug order. Any record generated in this process whether in a hard copy or electronic format shall be maintained for a minimum period of two years from the last date of entry. Such records may be maintained:
1. Separately by each pharmacy and pharmacist; or
2. In a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.
(10) In the operation of the off-site order entry, patient confidentiality and full compliance with
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HIPAA requirements shall be observed at all times.
(11) This rule does not apply to or allow any step of processing a prescription to be performed outside the physical premises of a pharmacy holding a permit with the Alabama State Board of Pharmacy. The following are expressly prohibited:
(a) Work from home, work from call centers, and work from portable or hand held computers operated outside a location holding a permit with the Alabama State Board of Pharmacy. The Board of Pharmacy may at any time audit the records of any pharmacy holding a permit to ensure compliance with this provision.
(12) Each hard copy prescription must be readily retrievable. Neither the original hard copy prescription, nor a scanned image of the original prescription shall be assigned more than one prescription number. Prescription numbers shall be sequential and shall only be used for numbering prescriptions; specifically they may not be created or used for billing or accounting purposes absent the dispensing of a prescription drug.
Author: Herb Bobo, R.Ph., Secretary
Statutory Authority: §34-23-92, Code of Alabama 1975
NON-DISCIPLINARY PENALTY FOR LATE RENEWAL OF LICENSE, PERMIT, REGISTRATION, CERTIFICATION, OR ANY SIMILAR DOCUMENT ISSUED
In the event an application for renewal of any type of license, permit, registration, certification or any other similar document issued and required by the Alabama Pharmacy Practice Act, the Alabama Uniform Controlled Substances Act or any applicable Rule and the appropriate renewal fee is not received in the Board’s office by December 31 of the applicable year, but is received in the Board’s office no later than January 31 of the following year, a non-disciplinary administrative penalty of fifty percent (50%) of the prevailing renewal fee must be paid by January 31 of the following year in order to renew. This penalty shall be in addition to the prevailing renewal fee.
(2) This Rule is adopted pursuant to the Board’s authority set forth in Code of Alabama (1975), § 34-23-33(b) and is in lieu of formal disciplinary proceedings.