Section 34-23-1
Section 34-23-1 Definitions.
For the purpose of this chapter, the following words and phrases shall have the following meanings:
(1) ASSOCIATION. The Alabama Pharmacy Association.
(2) BOARD or STATE BOARD. The Alabama State Board of Pharmacy.
(3) CHEMICAL. Any substance of a medicinal nature, whether simple or compound, obtained through the process of the science and art of chemistry, whether of organic or inorganic origin.
(4) 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.
(5) DRUGS. All medicinal substances, preparations, and devices recognized by the United States Pharmacopoeia and National Formulary, or any revision thereof, and all substances and preparations intended for external and internal use in the cure, diagnosis, mitigation, treatment, or prevention of disease in man or animal and all substances and preparations other than food intended to affect the structure or any function of the body of man or animal.
(6) EXTERN. A candidate for licensure as a pharmacist during the time prior to graduation from an accredited college of pharmacy.
(7) HOSPITAL. An institution for the care and treatment of the sick and injured, licensed by the Alabama State Board of Health and authorized to be entrusted with the custody of drugs and medicines, the professional use of drugs and medicines being under the direct supervision of a medical practitioner or pharmacist.
(8) INTERN. An individual who is currently licensed by this state to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist; or a graduate of an approved college of pharmacy who is currently licensed by the State Board of Pharmacy for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or a qualified applicant awaiting examination for licensure.
(9) LEGEND DRUG. Any drug, medicine, chemical, or poison bearing on the label the words, 'caution, federal law prohibits dispensing without prescription,' or similar wording indicating that such drug, medicine, chemical, or poison may be sold or dispensed only upon the prescription of a licensed medical practitioner.
(10) LICENSE. The grant of authority by the State Board of Pharmacy to a person authorizing him or her to engage in the practice of pharmacy in this state.
(11) MANUFACTURER. A person, except a pharmacy, who prepares, derives, produces, compounds, or packages any drug, medicine, chemical, or poison.
(12) MEDICAL PRACTITIONER. Any physician, dentist, or veterinarian, or any other person authorized by law to treat, use, or prescribe medicine and drugs for sick and injured human beings or animals in this state.
(13) MEDICINE. Any drug or combination of drugs that has the property of curing, diagnosing, preventing, treating, or mitigating diseases or that which may be used for those purposes.
(14) PATENT OR PROPRIETARY MEDICINES. Completely compounded nonprescription packaged drugs, medicines, and nonbulk chemicals which are sold, offered, promoted, or advertised by the manufacturer or primary distributor under a trademark, trade name, or other trade symbol, and the labeling of which conforms to the requirements of the Federal Food, Drug, and Cosmetic Act; provided, that this definition shall not include:
a. Drugs which are only advertised and promoted professionally to licensed physicians, dentists, or veterinarians by manufacturers or primary distributors.
b. A narcotic or drug containing a narcotic.
c. A drug the label of which bears substantially either the statements 'caution--federal law prohibits dispensing without prescription' or 'warning--may be habit-forming'.
d. A drug intended for injection.
(15) PERMIT. The grant of authority by the State Board of Pharmacy to any person, firm, or corporation authorizing the operation of a pharmacy, wholesale drug distributor, repackager, bottler, manufacturer, or packer of drugs, medicines, chemicals, or poisons for medicinal purposes. Nonresident wholesale drug distributors registered with the appropriate agency, in the state in which they are domiciled, and operating in compliance with Prescription Drug Marketing Act standards, shall be allowed to do business in this state. No permit shall be required of any physician licensed to practice medicine for any act or conduct related to or connected with his or her professional practice.
(16) PERSON. Any individual, partnership, corporation, association, trust, or other entity.
(17) PHARMACIST. Any person licensed by the Alabama State Board of Pharmacy to practice the profession of pharmacy in the State of Alabama and whose license is in good standing.
(18) PHARMACY. A place licensed by the Alabama State Board of Pharmacy in which prescriptions, drugs, medicines, medical devices, chemicals, and poisons are sold, offered for sale, compounded, or dispensed, and shall include all places whose title may imply the sale, offering for sale, compounding, or dispensing of prescriptions, drugs, medicines, chemicals, or poisons.
(19) POISON. Any substance other than agricultural products and pesticides which when applied to, introduced into, or developed within the body in relatively small quantities by its inherent chemical action uniformly produces serious bodily injury, disease, or death.
(20) PRECEPTOR. A person who is duly licensed to practice pharmacy in the state and meets the requirements as established by the State Board of Pharmacy.
(21) PRESCRIPTION. Any order for drug or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph, closed circuit television, or other means of communication by a legally competent practitioner, licensed by law to prescribe and administer such drugs and medical supplies intended to be filled, compounded, or dispensed by a pharmacist.
(22) PROFESSIONAL DEGREE. A degree in pharmacy requiring a minimum of five academic years.
(23) REPACKAGER. A person who purchases or acquires from a manufacturer or distributor, a drug, medicine, chemical, or poison for the purpose of bottling, labeling, or otherwise repackaging for sale or distribution. This definition shall not apply to a physician licensed to practice medicine who as a part of his or her professional practice dispenses, administers, sells, or otherwise distributes any drug to a patient.
(24) SALE. Barter, exchange, or gift, or offer of barter, exchange, or gift, and shall include each transaction made by any person, whether a principal, proprietor, agent, servant, or employee.
(25) WHOLESALE DRUG DISTRIBUTORS. A person engaged in the business of distributing drugs and medicines for resale to pharmacies, hospitals, practitioners, government agencies, or other lawful outlets permitted to sell drugs or medicines. The sale, purchase, or trade of a drug by a retail pharmacy to another retail pharmacy or practitioner, for relief of temporary shortages, is exempt from this definition. Also exempt from this definition shall be (a) intracompany sales, (b) manufacturer and distributor sales representatives who distribute drug samples, (c) charitable organizations distributing to nonprofit affiliates of that organization, (d) certain purchases by hospitals or other health care entities that are members of a group purchasing organization, and (e) the distributors of blood and blood components.
(Acts 1966, Ex. Sess., No. 205, p. 231, §2; Acts 1991, No. 91-475, p. 860, §1; Act 98-643, p. 1414, §1.)Section 34-23-10
Section 34-23-10 Notification by pharmacists of change of employment.
Each pharmacist licensed by the board shall notify the board in writing within 10 days on change of employment. The notice shall contain his name, license number, the name of the pharmacy where formerly employed and the name of the pharmacy where currently employed.
(Acts 1966, Ex. Sess., No. 205, p. 231, §12.)Section 34-23-11
Section 34-23-11 Physicians, dentists, registered nurses, etc. exempt from chapter.
(a) Nothing contained in this chapter shall prevent any licensed practitioner of the healing arts from personally compounding, dispensing, administering, or supplying to his or her patient drugs and medicines for their use. This chapter shall not apply to the manufacture or sale at wholesale or retail of patent or proprietary medicines as purchased from a manufacturer or wholesaler, or to the manufacture or sale at wholesale or retail of packaged, bottled, or nonbulk chemicals, medicines, medical and dental supplies, cosmetics, and dietary foods when identified by and sold under a trademark, trade name, or other trade symbol, privately owned or registered in the United States Patent Office, sold or offered to be sold to the general public, if the article meets the requirements of the federal Food, Drug, and Cosmetic Act other than prescription legend drugs.
(b) A registered nurse in the employment of the State Health Department or a county health department may, in the provision of health care services, dispense legend drugs as provided in this section under the standing orders or direct supervision of a physician licensed to practice medicine in this state and pursuant to procedures established by the Board of Pharmacy and implemented by a pharmacist licensed to practice pharmacy in this state. The nurse may dispense the legend drugs for the treatment of tuberculosis, sexually transmitted diseases, family planning, hypertension, and other programs if approved by the State Board of Pharmacy. The dispensing of the drugs shall meet all labeling, packaging, recordkeeping, and counseling requirements of a prescription. The Board of Pharmacy shall have the responsibility to inspect the site where the dispensing occurs. The authority granted to a registered nurse pursuant to this subsection shall not apply to controlled substances as defined in Chapter 2 of Title 20.
(Acts 1966, Ex. Sess., No. 205, p. 231, §32; Acts 1997, No. 97-643, p. 1176, §1.)Section 34-23-110
Section 34-23-110 Short title.
This article shall be known and may be cited as the 'Third Party prescription Program Act.'
(Acts 1981, No. 81-337, p. 477, §1.)Section 34-23-111
Section 34-23-111 'Third Party Prescription Program' defined.
As used in this article, the term 'Third Party Prescription Program' shall mean any system of providing for the reimbursement of pharmaceutical services under a contractual arrangement or agreement between a provider of such services and another party who is not the consumer of those services. Such programs may include, but not be limited to, employee benefit plans whereby a consumer receives prescription drugs or other pharmaceutical services and those services are paid for by an agent of the employer or others.
(Acts 1981, No. 81-337, p. 477, §2.)Section 34-23-112
Section 34-23-112 Required contractual provisions.
Any agreement or contract entered into in this state between the program administrator of a third party program and a pharmacy shall include a statement of the method and amount of reimbursement to the pharmacy for services rendered to persons enrolled in the program, the frequency of payment by the program administrator to the pharmacy for such services rendered, and a method for the adjudication of complaints or the settlement of disputes between the parties.
(Acts 1981, No. 81-337, p. 477, §3.)Section 34-23-113
Section 34-23-113 Cancellation of program; use of identity card after cancellation.
(a) The administrator of a program shall notify all pharmacies enrolled in said program of any cancellation of coverage of benefits of any group enrolled in the program at least 30 days prior to the effective date of such cancellation.
(b) All persons enrolled in a program shall be notified of its cancellation, and the administrator of the program shall make every reasonable effort to gain possession of any plan identification cards such persons may have been issued pursuant to the provisions of the program.
(c) Any person who utilizes a program identification card to obtain services from a pharmacy after having received notice of the cancellation of his benefits shall be liable to the program administrator for all money paid by the program administrator for any services received pursuant to the illegal use of said identification card.
(Acts 1981, No. 81-337, p. 477, §4.)Section 34-23-114
Section 34-23-114 Denial of payment.
(a) No program administrator shall deny payment for services to any pharmacy which may have resulted from the fraudulent or illegal use of any identification card by any person unless the pharmacy has been notified that the card has been canceled or discontinued and that the program administrator has been unsuccessful in attempting to regain possession of the card.
(b) No program administrator shall withhold any payments to any pharmacy beyond the time period specified in the payment schedule provisions of the agreement, except that individual claims for payment may be returned to the pharmacy for reasons such as incomplete or illegible information and may then be resubmitted by the pharmacy to the program administrator after appropriate corrections have been made.
(Acts 1981, No. 81-337, p. 477, §5.)Section 34-23-115
Section 34-23-115 Reimbursement rates.
No agreement between a program administrator and a pharmacy shall establish reimbursement rates or procedures that result in reimbursement rates for services rendered to persons covered by the plan which are less than the usual and customary rates paid by consumers not covered by a third party plan for the same or similar services.
(Acts 1981, No. 81-337, p. 477, §6.)Section 34-23-116
Section 34-23-116 Article not applicable to Medicaid services or to services reimbursed by nonprofit corporations operating health care service plans.
This article shall not apply to any services rendered pursuant to provisions of the Alabama Medicaid Program or to any corporation organized under the provisions of Title 10, Chapter 4, Article 6, for establishment and operation of health care service plans.
(Acts 1981, No. 81-337, p. 477, §7; Acts 1983, No. 83-637, p. 986, §§1, 2.)Section 34-23-117
Section 34-23-117 No programs to be instituted until notice given.
After June 27, 1981, no third party prescription programs shall be instituted in this state unless:
(1) The program administrator has given written notice of the provisions of the particular program to all pharmacies in this state as defined in Section 34-23-1.
(2) All pharmacies in this state as defined by Section 34-23-1 have had 30 days from the date of said notice to enroll in that particular program.
(Acts 1981, No. 81-337, p. 477, §8.)Section 34-23-118
Section 34-23-118 Compliance with article required of all programs.
After June 27, 1981, no third party prescription program shall be instituted, nor shall existing agreement or contract be renewed unless they are in compliance with the provisions of this article.
(Acts 1981, No. 81-337, p. 477, §11.)Section 34-23-12
Section 34-23-12 Injunctions against violations of chapter.
When it shall appear to the board that any person who is not licensed under the provisions of this chapter is violating any of the provisions of this chapter, the board may in its own name bring an action in the circuit court for an injunction, and said court of this state may enjoin any person from violating the provisions of this chapter regardless of whether proceedings have been or may be instituted before the board or whether criminal proceedings have been or may be instituted.
(Acts 1966, Ex. Sess., No. 205, p. 231, §23.)Section 34-23-13
Section 34-23-13 Penalty for practicing pharmacy without a license; compounding or dispensing prescriptions by unauthorized persons; violations of chapter or rules and regulations of board.
Any person who shall practice pharmacy in this state without having first obtained from the board a license, or who permits prescriptions to be compounded and/or dispensed by unauthorized persons; or who violates any of the provisions of this chapter; or who willfully violates any published rule or regulation of the board; or who does any act described in this chapter as unlawful, the penalty for which is not herein specifically provided, shall be guilty of a misdemeanor and, upon conviction, shall be punished by fine of not more than $1,000.00 for each offense, to be fixed by the court trying said case, and in addition thereto may be, in the discretion of the court trying said case, sentenced to hard labor for the county for a period not to exceed 12 months.
(Acts 1966, Ex. Sess., No. 205, p. 231, §10.)Section 34-23-130
Section 34-23-130 Definitions.
As used in this article, the following terms shall have the following meanings:
(1) PHARMACY FUNCTIONS. Those functions performed in a pharmacy department which do not require the professional judgment of a licensed pharmacist.
(2) PHARMACY TECHNICIAN. An individual, other than an intern, extern, or an assistant pharmacist, who performs pharmacy functions under the direct supervision of a licensed pharmacist.
(3) SUPERVISION. The direct on-site overseeing of the performance of assigned or delegated duties or functions.
(Acts 1996, No. 96-496, p. 625, §1.)Section 34-23-131
Section 34-23-131 Registration and supervision; rules and regulations; continuing education.
(a) A pharmacy technician shall not perform pharmacy functions or be present in the prescription department of a pharmacy unless he or she is under the direct supervision of a licensed pharmacist. A pharmacy technician shall not perform pharmacy functions or be present in the prescription department of a pharmacy unless he or she is registered by the board.
(b) When supervision is required, a licensed pharmacist shall be jointly responsible and liable for the actions of a pharmacy technician.
(c) A pharmacy technician shall register and pay a fee as determined by the board before performing any pharmacy functions. The board shall develop rules and regulations relating to the registration of all pharmacy technicians. The registration of a pharmacy technician shall be renewable biennially in odd-numbered years upon payment of the required fee.
(d) In addition to any other registration requirements, a pharmacy technician shall complete three hours of continuing education annually, of which one hour shall be live presentation.
(Acts 1996, No. 96-496, p. 625, §2; Act 2004-450, p. 801, §1.)Section 34-23-132
Section 34-23-132 Revocation or suspension of registration; probation.
The board shall revoke or suspend the registration of a pharmacy technician or place on probation a pharmacy technician for any of, but not limited to, the following reasons:
(1) Willful violation of any provision of this article or the Alabama Uniform Controlled Substances Act.
(2) Willful violation of any rule or regulation promulgated in accordance with this article or the Alabama Uniform Controlled Substances Act.
(3) Action which threatens the public health, safety, or welfare.
(4) Conviction of a felony or misdemeanor involving moral turpitude.
(5) Conviction of a felony or misdemeanor involving a drug related offense of a legend drug or controlled substance.
(6) Obtaining the pharmacy technician registration by fraudulent means.
(7) Violation of the laws regulating the sale or dispensing of narcotics, exempt narcotics, or drugs bearing the label 'caution, federal law prohibits dispensing without prescription,' or similar wording which causes the drugs to be classified as prescription legend drugs.
(Acts 1996, No. 96-496, p. 625, §3.)Section 34-23-150
Section 34-23-150 Definitions.
As used in this article, the following terms shall have the following meanings:
(1) BOARD. The Alabama State Board of Pharmacy.
(2) COMPONENT. Any ingredient used in the compounding of a drug product.
(3) COMPOUNDING. The preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a licensed practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice.
a. Compounding may also be for the purpose of, or as incident to, research, teaching, or chemical analysis.
b. Compounding includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
c. Reconstitution of commercial products is not considered compounding for purposes of this article.
(4) COMPOUNDED OVER THE COUNTER (OTC) PRODUCTS. A medical product that is prepared, packaged, and labeled in a pharmacy that can be sold by the pharmacy without a prescription.
(5) MANUFACTURING. The production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes any packaging or repackaging of the substance or substances or labeling or relabeling of its container, and the promotion and marketing of such drugs or devices. Manufacturing also includes any preparation of a drug or device that is given or sold for resale by a pharmacy, practitioner, or other person. The distribution of inordinate amounts of compounded products without a prescriber/patient/pharmacist relationship is considered manufacturing.
(6) PHARMACY TECHNICIAN. A person, registered with the board, who assists the pharmacist in the practice of compounding.
(7) REASONABLE AMOUNTS OF COMPOUNDED PRODUCTS IN INVENTORY. The amount that is required to meet historical dispensing needs.
(Act 2003-389, §1.)Section 34-23-151
Section 34-23-151 Continuing education; technician assistance; duties of pharmacist.
(a) Any pharmacist who engages in drug compounding shall be proficient in compounding and shall continually expand his or her compounding knowledge by participating in seminars or studying appropriate literature, or both.
(b) Pharmacy technicians may assist pharmacists in the preparation of compounds. When a written procedure for a compound is not on file at the pharmacy, a pharmacist must direct the preparation of the compound. At all times, a pharmacist shall verify the weight or volume of all active ingredients of a compound. While compounding, there shall be no more than three technicians per pharmacist.
(c) A pharmacist shall have responsibility to do all of the following:
(1) Verify all prescriptions.
(2) Approve or reject all components of the compounded product, drug product containers, closures, and labeling.
(3) Prepare and review all compounding records to assure that no errors have occurred in the compounding process.
(4) Assure the proper maintenance, cleanliness, and use of all equipment used in a prescription compounding practice.
(5) Assure that only personnel authorized by the supervising pharmacist shall be in the immediate vicinity of the drug compounding operation.
(Act 2003-389, §2.)Section 34-23-152
Section 34-23-152 Designation and maintenance of compounding area.
Any pharmacy engaged in compounding shall have a specifically designated and adequate area or space for the orderly compounding of prescriptions. The area used for the compounding of drugs shall be maintained in a good state of repair. The compounding area shall have smooth cleanable surfaces to include walls, ceilings, and floors. Adequate lighting and ventilation shall be provided in all compounding areas. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product. Areas used for compounding shall be maintained in a clean and sanitary condition.
(Act 2003-389, §3.)Section 34-23-153
Section 34-23-153 Use, maintenance, and inspection of compounding equipment.
Equipment used in the compounding of drug products shall be of appropriate design and capacity, as well as suitably located to facilitate operations for its intended use, cleaning, and maintenance. Compounding equipment shall be of suitable composition so the surfaces that contact components shall not be reactive, additive, or absorptive so as to alter the purity of the product compounded. Equipment and utensils used for compounding shall be cleaned and sanitized prior to use to prevent contamination. Equipment and utensils shall be stored in a manner to protect from contamination. Automated, mechanical, electronic, limited commercial scale manufacturing, or testing equipment and other types of equipment may be used in the compounding of drug products. If such equipment is used, it shall be routinely inspected, calibrated, if necessary, or checked to ensure proper performance. Immediately prior to the initiation of compounding operations, the equipment and utensils shall be inspected by the pharmacist and determined to be suitable for use. When potent or hazardous drugs, such as antibiotics, cytotoxins, and steroid hormones, are involved, appropriate measures shall be utilized in order to prevent cross-contamination and proper disposal procedures shall be followed. Measures shall include either the dedication of equipment for such operations or the meticulous cleaning of equipment prior to its use for the preparation of other drugs.
(Act 2003-389, §4.)Section 34-23-154
Section 34-23-154 Drug components to meet certain requirements.
Pharmacists compounding prescriptions shall use their professional judgment in first receiving, storing, or using drug components that meet official compendia requirements or other high quality sources. Bulk drugs and other chemicals or materials used in the compounding of drugs shall be stored in adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.
(Act 2003-389, §5.)Section 34-23-155
Section 34-23-155 Drug product containers and closures.
Drug product containers and closures shall be handled and stored in a manner to prevent contamination and to permit inspection and cleaning of the work area. Containers and closures shall be of suitable material in order not to alter the compounded drug as to quality, strength, or purity.
(Act 2003-389, §6.)Section 34-23-156
Section 34-23-156 Compounding procedures.
The board shall establish written procedures for the compounding of drug products to assure that the finished products have the identity, strength, quality, and purity they purport to have or are represented to possess. The procedures shall include, but not be limited to, a listing of the components, their amounts in weight or volume, the lot number of the components, if available, the order of component mixing, a description of the compounding process, and a designated name for the finished product. The procedures shall be followed in the execution of the compounding procedure. Components shall be accurately weighed, measured, or subdivided, as appropriate. The operations shall be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight and measure is correct as stated in the written compounding procedures. Pharmacists shall determine that all finished products have an acceptable degree of weight variation among capsules, and shall assure a reasonable uniformity and integrity of all compounded products.
(Act 2003-389, §7.)Section 34-23-157
Section 34-23-157 Components transferred to nonoriginal container; advance product preparation; labeling.
(a) If a component is transferred from the original container to another container, including, but not limited to, a powder being taken from the original container and stored in another container, the new container shall be identified with the following information:
(1) Component name and supplier.
(2) Lot number and expiration date, if available.
(3) Strength and concentration.
(b) Products prepared in anticipation of a prescription prior to receiving a valid prescription shall be prepared in reasonable amounts. Products shall be labeled or documentation referenced with all of the following information:
(1) A complete list of ingredients or designated name of the preparation.
(2) Preparation date.
(3) Beyond use date.
(4) Storage under conditions dictated by composition and stability, including storage in a clean, dry place or in the refrigerator.
(5) Batch or lot number.
(c) Upon the completion of the drug preparation operation, the pharmacist shall examine the product for correct labeling. The prescription label shall contain all of the information required of other prescriptions.
(Act 2003-389, §8.)Section 34-23-158
Section 34-23-158 Retention of records.
Any procedures or other records required to comply with good compounding practices shall be retained for the same period of time as required for retention of prescription records. All records required to be retained under good compounding practices, or copies of such records, shall be readily available for authorized inspection. Computer information and the hard copy of the prescription shall indicate that the prescription is to be compounded. Adequate records are required to be kept of any controlled dangerous substances or scheduled drugs which are used in compounding.
(Act 2003-389, §9.)Section 34-23-159
Section 34-23-159 Preparation of compounded drug products for over the counter sale.
A pharmacy may prepare a compounded drug product to be sold over the counter without a prescription order. The product shall not contain an ingredient which exceeds recommended strengths and doses for over the counter drugs. The finished product shall not be one for which a prescription is required. It shall be properly labeled with the product's name, directions for use, list of active ingredients, and any necessary warnings. A compounded product shall be sold directly to the consumer after professional interaction or consultation between the pharmacist and the consumer. The product may be prepared in advance in reasonable amounts in anticipation of estimated needs. The product shall be stored within the prescription department. The product may not be sold in bulk to other pharmacies or vendors for resale.
(Act 2003-389, §10.)Section 34-23-160
Section 34-23-160 Preparation of compounded drug products for prescriber's office use; labeling.
(a) A pharmacy may prepare a compounded drug product for a prescriber's office use. An order by a prescriber indicating the formula and quantity ordered shall be filed in the pharmacy. The product shall be administered in the prescriber's office and shall not be dispensed to the consumer. A record of the compounded drug product may be kept as a prescription record in the computer of the pharmacy. A label may be generated and a number assigned by the computer of the pharmacy for the compounded product. A record of the product's written procedure shall be on file in the pharmacy as provided in Section 34-23-156. A record of the product's sale to the prescriber shall remain on file at the pharmacy for not less than one year. The record shall contain the following information:
(1) The name and address of the prescriber.
(2) The date of sale.
(3) A description and amount of the product sold.
(b) The label on the compounded product shall include the following information:
(1) The designated name and the strength of the finished product.
(2) The quantity dispensed.
(3) The date on which the product was compounded.
(4) The beyond use date.
(5) A lot or batch number.
(6) Any other information the pharmacist deems necessary.
(7) The name and address of the pharmacy.
(c) The label may not include the phrase 'For Office Use.'
(Act 2003-389, §11.)Section 34-23-161
Section 34-23-161 Prescriptions for animals.
Drugs for animals may be compounded based upon an order or prescription. Prescriptions for animals shall be handled and filled in the same manner as are prescriptions for humans.
(Act 2003-389, §12.)Section 34-23-162
Section 34-23-162 Rules and regulations.
The board shall promulgate such rules and regulations as are necessary for the implementation, administration, and enforcement of this article.
(Act 2003-389, §13.)Section 34-23-2
Section 34-23-2 Objects and purposes of chapter.
The practice of pharmacy and the management and operation of pharmacies are hereby declared to affect the public health, safety and welfare of the people of Alabama, and thereby subject to regulation and control in the public interest. It is further declared to be a matter of public interest and concern that only qualified persons compound or dispense prescription drugs and medicines, and that pharmacies be managed in such a manner as to protect the public, and all provisions of this chapter shall be liberally construed to carry out these objects and purposes.
(Acts 1966, Ex. Sess., No. 205, p. 231, §1.)Section 34-23-3
Section 34-23-3 State drug inspectors.
Each state drug inspector employed by the board following the passage of this chapter must furnish satisfactory proof to the board that he is a person of good moral character and that in the judgment of the members of the board he has sufficient knowledge of the laws pertaining to the practice of pharmacy and law enforcement to enable him to carry out his duties as an inspector consistent with the provisions of this chapter. Each state drug inspector employed by the board shall serve an apprenticeship of a minimum of six months working with and under the supervision of the Chief Drug Inspector or other inspector designated by the board. Each such inspector, before entering upon his duties, shall post with the State Board of Pharmacy a bond in the amount of $2,000.00 conditioned upon the faithful performance of his duties. Each state drug inspector shall have the power to inspect the medicines and drugs or drug products or domestic remedies which are manufactured, packaged, packed, made, sold, offered for sale, exposed for sale or kept for sale in this state, and for this purpose shall have the right to enter and inspect during business hours any pharmacy or any other place in this state where medicines or drugs or drug products or proprietary medicines are manufactured, packaged, packed, made, sold, offered for sale or kept for sale, whether or not licensed by the state board of pharmacy. Each state drug inspector shall be subject to the same restrictions as other officers of the law in regard to search and seizure. They shall report to the board all violations of the laws relating to pharmacy and all rules and regulations of the board. As directed by the board, it shall be the duty of the state drug inspectors to issue citations for violations of such laws, rules or regulations or institute criminal proceedings against persons for such violations. When authorized by the board and where there are specific complaints, the state drug inspector shall have the right to inspect all records, shipping tickets or any other document pertaining to the transfer of drugs or drug preparations, from or to hospitals, pharmacists, wholesale establishments and manufacturers, or any other place or establishment where said preparations of drugs are kept or stored. They shall have the authority to inspect all prescription files, prescription record books, poison registers, exempt narcotic registers and any other records pertaining to the filling and filing of prescriptions. It shall be the duty of the state drug inspector to take possession of all revoked and/or suspended licenses and permits when such licenses and permits are not surrendered voluntarily to the board by the person or pharmacist whose license or permit has been revoked or suspended. Nothing in this chapter shall authorize or require the state drug inspector or state drug inspectors to inspect the offices of doctors of medicine who have duly qualified with the State Board of Medical Examiners.
(Acts 1966, Ex. Sess., No. 205, p. 231, §7.)Section 34-23-30
Section 34-23-30 Pharmacy permits generally.
Every pharmacy, hospital pharmacy, drugstore, pharmacy department, prescription department, prescription laboratory, dispensary, apothecary or any other establishment with a title implying the sale, offering for sale, compounding, or dispensing of drugs in this state shall register biennially and receive a permit from the Board of Pharmacy. Any person desiring to open, operate, maintain, or establish a pharmacy in this state shall apply to the board for a permit at least 30 days prior to the opening of the business. No pharmacy shall open for the transaction of business until it has been registered, inspected, and a permit issued by the board. The application for a permit shall be made on a form prescribed and furnished by the board which when properly executed shall indicate the ownership desiring such permit and the names and license numbers of all licensed pharmacists employed as well as the location of the pharmacy and other information as the board may require. If more than one pharmacy is operated by the same owner, a separate application for registration shall be made and a separate permit issued for each such establishment. All permits issued under this section shall become due on October 31 and shall become null and void on December 31 of even-numbered years. Every application for a permit for a new pharmacy shall be accompanied by a fee to be determined by the board, but the fee shall not be less than one hundred dollars ($100) nor more than two hundred dollars ($200). Every application for a renewal permit shall be accompanied by a fee to be determined by the board, but the fee shall not be less than fifty dollars ($50) nor more than one hundred fifty dollars ($150). Every application for a permit due to transfer of ownership shall be accompanied by a fee to be determined by the board, but the fee shall not be less than fifty dollars ($50) nor more than one hundred fifty dollars ($150). Each application for the renewal of a permit shall be made on or before October 31 of each even-numbered year, at which time the previous permit shall become null and void on December 31 of even-numbered years. A penalty of twenty-five dollars ($25) for each overdue month shall be assessed in addition to the permit fee for renewal of delinquent permits. The secretary of the board shall issue a permit for each pharmacy whose application is found to be satisfactory by the board. Permits issued under this section shall not be transferable. Any change in the control of ownership or licensed pharmacists shall be reported to the board in writing within 10 days of such occurrence. If the pharmacy is owned by a corporation, the permit shall be issued in the name of the corporation. It shall be the duty of the owners of pharmacies who are not licensed pharmacists to immediately notify the board upon the termination of employment of licensed pharmacists and to cause the surrender of permits as indicated. The further operation of the pharmacy in the absence of licensed pharmacists is forbidden; provided, that the nonregistered owner shall have a period of 30 days within which to comply with this provision. The next of kin of any deceased licensed pharmacist owner shall have a period of 30 days within which to comply with the provisions of this chapter, during which time no prescriptions shall be filled unless a licensed pharmacist is on duty. No mail order pharmacy shall transact business in this state without a permit from the board.
Any person who violates this section shall be guilty of a misdemeanor.
(Acts 1966, Ex. Sess., No. 205, p. 231, §14; Acts 1985, No. 85-702, p. 1151, §1; Act 2004-450, p. 801, §1.)Section 34-23-31
Section 34-23-31 Permits for mail-order houses.
Every mail-order house which dispenses drugs or medicines through the United States mail or otherwise from any point in the state of Alabama to any point outside of the State of Alabama, and every such business which dispenses drugs or medicines through the United States mail or otherwise from any point outside of the State of Alabama to any point within the State of Alabama shall obtain a permit from the State Board of Pharmacy as a condition precedent to being qualified and authorized to transact such business in the State of Alabama.
(Acts 1966, Ex. Sess., No. 205, p. 231, §29.)Section 34-23-32.1
Section 34-23-32.1 FDA requirements to be adhered to by affected parties.
Any requirements established by the FDA Guidelines, as required by the Federal Prescription Drug Marketing Act of 1987 (PDMA), specifically addressed in Sections 34-23-1 and 34-23-32, shall be adhered to by the affected parties.
(Acts 1991, No. 91-475, p. 860, §2.)Section 34-23-32
Section 34-23-32 Manufacturer, bottler, packer, repackager, or wholesale distributor of drugs.
(a) Every manufacturer, bottler, packer, repackager, or wholesale drug distributor, of drugs, medicines, chemicals, or poisons for medicinal purposes shall register biennially with the board by application for a permit on a form furnished by the board and accompanied by a fee to be determined by the board as follows:
(1) The fee shall not be less than five hundred dollars ($500) nor more than two thousand dollars ($2,000) for a new establishment.
(2) The fee shall not be less than two hundred fifty dollars ($250) nor more than one thousand dollars ($1,000) for a renewal permit.
(3) The fee shall not be less than two hundred fifty dollars ($250) nor more than one thousand dollars ($1,000) for a permit due to transfer of ownership.
(b) A holder of a permit shall employ a full-time licensed pharmacist whose principal duty shall be confined to on-premise pharmaceutical operations. Wholesale drug distributors, who strictly limit their operation to distribution of drugs, medicines, chemicals, or poisons for medicinal purposes are exempt from the requirement to employ a full-time licensed pharmacist.
(c) The professional practice of any physician licensed to practice medicine is exempt from the requirements of this section.
(d) All permits issued under this section 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. A penalty of twenty-five dollars ($25) for each overdue month shall be assessed in addition to the permit fee for renewal of delinquent permits. For each application for a permit made and found to be satisfactory by the board, the secretary of the board shall issue to the applicant a permit for such manufacturing or wholesale establishment, which permit shall be displayed in a conspicuous place.
(e) All holders of a permit shall, before shipping any drug bearing the legend, 'caution, federal law prohibits dispensing without prescription' or similar wording causing these drugs to be known as legend drugs to new customers, assure themselves that the recipient is either a duly licensed doctor of medicine, dentistry, or veterinary medicine or holds a registered pharmacy permit from the board by contacting the office of the board. No holder of a permit shall ship any legend drug to any person or firm after receiving written notice from the board that the person or firm no longer holds a registered pharmacy permit. Any person violating this section shall be guilty of a misdemeanor.
(Acts 1966, Ex. Sess., No. 205, p. 231, §24; Acts 1985, No. 85-702, p. 1151, §1; Acts 1991, No. 91-475, p. 860, §1; Act 2004-450, p. 801, §1.)Section 34-23-33
Section 34-23-33 Revocation or suspension of licensed pharmacist, holder of pharmacy intern or extern certificate, permit to operate - Grounds.
The board may revoke, suspend, place on probation, or require remediation for any licensed pharmacist or a holder of a pharmacy intern or extern certificate for a specified time as determined by the board and take the same or similar action against the permit to operate any pharmacy in this state, whenever the board finds by a preponderance of the evidence, or pursuant to a consent decree, that the pharmacist has been guilty of any of the following acts or offenses:
(1) Obtaining the license to practice pharmacy or the permit to operate a pharmacy by fraudulent means.
(2) Violation of the laws regulating the sale or dispensing of narcotics, exempt narcotics or drugs bearing the label 'caution, federal law prohibits dispensing without prescription,' or similar wording which causes the drugs to be classified as prescription legend drugs.
(3) Conviction of a felony. A copy of the record of the conviction, certified by the clerk of the court entering the conviction, shall be conclusive evidence of the conviction.
(4) Conviction of any crime or offense that reflects the inability of the practitioner to practice pharmacy with due regard for the health and safety of the patients.
(5) Inability to practice pharmacy with reasonable skill and safety to patients by reason of illness, inebriation, misuse of drugs, narcotics, alcohol, chemicals or any other substance, or as a result of any mental or physical condition.
When the issue is whether or not a pharmacist is physically or mentally capable of practicing pharmacy with reasonable skill and safety to patients, then, upon a showing of probable cause to the board that the pharmacist is not capable of practicing pharmacy with reasonable skill and safety to patients, the board may require the pharmacist in question to submit to a psychological examination by a psychologist to determine psychological status or a physical examination by a physician, or both, to determine physical condition. The psychologist or physician, or both, shall be designated by the board. The expense of the examination shall be borne by the board. Where the pharmacist raises the issue of mental or physical competence or appeals a decision regarding his or her mental or physical competence, the pharmacist shall be permitted to obtain his or her own evaluation at the pharmacist's expense. If the objectivity or adequacy of the examination is suspect, the board may complete the examination by the designated practitioners at its own expense. When mental or physical capacity to practice is at issue, every pharmacist licensed to practice pharmacy in the state shall be deemed to have given consent to submit to a mental or physical examination or to any combination of the examinations and to waive all objections to the admissibility of the examination, or to previously adjudicated evidence of mental incompetence.
(6) Gross malpractice or repeated malpractice or gross negligence in the practice of pharmacy.
(7) Violation of any provisions contained in this chapter.
(8) Employing, assisting or enabling in any manner any unlicensed person to practice pharmacy.
(9) The suspension, revocation, or probation by another state of a license to practice pharmacy. A certified copy of the record of suspension, revocation, or probation of the state making such a suspension, revocation, or probation shall be conclusive evidence of the suspension, revocation, or probation.
(10) Refusal to appear before the board after having been ordered to do so in writing by the executive officer or chair of the board.
(11) Making any fraudulent or untrue statement to the board.
(12) Violation of any rule or regulation of the board.
(13) Violation of the code of professional conduct adopted by the board in the rules and regulations of the board.
(Acts 1966, Ex. Sess., No. 205, p. 231, §20; Acts 1989, No. 89-235, p. 303, §3; Acts 1990, No. 90-550, p. 856, §1; Acts 1995, No. 95-585, p. 1243, §1.)Section 34-23-34
Section 34-23-34 Revocation or suspension of licenses to practice pharmacy and pharmacy permits — Statement of charges and notice of hearing.
No action to revoke or suspend the license of any pharmacist or the permit to operate any pharmacy in this state shall be taken until the licensee or holder of such permit has been furnished a statement in writing of the charges against him together with a notice of the time and place of hearing. The statement of charges and notice shall be served upon such a person at least 30 days before the date fixed for said hearing, either personally or by registered or certified mail sent to his last known post-office address. The burden of proof shall be on the board.
(Acts 1966, Ex. Sess., No. 205, p. 231, §21.)Section 34-23-4
Section 34-23-4 Recognition of schools and colleges of pharmacy.
The Board of Pharmacy shall recognize only those schools and colleges of pharmacy which are accredited by the American Council on Pharmaceutical Education and are members of the American Association of Colleges of Pharmacy.
(Acts 1966, Ex. Sess., No. 205, p. 231, §8.)Section 34-23-50
Section 34-23-50 Required.
It shall be unlawful for any person, firm or corporation to practice pharmacy in this state or to permit prescriptions to be compounded and/or dispensed by persons other than those duly licensed by the board to practice pharmacy in this state; provided, that any person who holds a professional degree in pharmacy from a school of pharmacy recognized by the board who is serving his internship under the immediate direct supervision of a pharmacist on the premises registered by the board and any person who is enrolled in a school of pharmacy recognized by the board working under the immediate and direct supervision of a pharmacist on the premises registered by the board pursuing his education as a pharmacist shall be permitted to compound and/or dispense prescriptions. In order to be considered enrolled in a school of pharmacy and pursuing his education as a pharmacist, a person shall not be absent from said school of pharmacy for more than two consecutive semesters or three consecutive quarters, dependent upon the system in use in said school of pharmacy. Any bona fide resident of this state who shall furnish proof to the board in person by affidavits from two pharmacists licensed by the State Board of Pharmacy, neither of whom shall be related to the applicant by blood or marriage, within a period of 90 days subsequent to August 26, 1966, establishing the fact that he has filled prescriptions under the supervision of a licensed pharmacist over a period of at least 15 successive years next preceding the offer of such proof shall be issued an assistant's certificate which will authorize him to practice pharmacy in this state; provided, that he shall be under the supervision of a licensed pharmacist at all times, and such person shall be subject to all of the provisions of this chapter governing the practice of pharmacy in this state, including, but not limited to, the revocation or suspension of such certificate for violations of the provisions of this chapter; and provided further, that such person shall pay an original registration fee to be determined by the board, but said fee shall not be less than $25.00 nor more than $50.00 upon the issuance of such certificate and the annual renewal fee to be determined by the board, but said fee shall not be less than $10.00 nor more than $50.00 as provided in this chapter. As used in the preceding sentence, the term 'supervision' shall be construed to mean that the supervising licensed pharmacist shall be either personally present or on call and available for consultation at all times, or a licensed pharmacist designated by the supervising licensed pharmacist shall be either personally present or on call and available for consultation at all times.
(Acts 1966, Ex. Sess., No. 205, p. 231, §9; Acts 1985, No. 85-702, p. 1151, §1.)Section 34-23-51
Section 34-23-51 Application for license; qualifications of applicants; examination of applicants; license by reciprocity.
Every person who desires to practice pharmacy within this state shall file with the secretary of the board his or her written application for licensure upon forms furnished by the board not less than 10 days prior to his or her examination. The application shall be accompanied by an examination and registration fee for residents and nonresidents of this state, the fees to be set by the board. The application shall be accompanied by two recent photographs of the applicant, no larger than 2 1/2 x 3 1/4 inches and certified on the back of each photograph by a notary public. The applicant shall furnish satisfactory proof that he or she is at least 19 years of age, of good moral character, and 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 applicant shall have completed an approved practical training program under the supervision of a licensed pharmacist in a site recognized by the board as qualified for training pharmacy externs and interns, the training standards to be established by the board as long as the standards are not less than those set by the National Association of Boards of Pharmacy. The completion of the practical training requirements shall be attested by affidavit from the licensed pharmacist preceptor under whom the training is served. The applicant shall pass an examination administered by the board in subjects consistent with those required by the National Association of Boards of Pharmacy and in accordance with the rules and regulations of the board. In case of failure of a first examination, the applicant shall have within three years the privilege of a second and third examination. In case of failure in the third examination, the applicant shall be eligible for only one additional examination and this only after he or she has satisfactorily completed additional preparation as directed and approved by the board. An applicant may be admitted to the examination provided all of the foregoing requirements are met, and in addition, that affidavits attesting to the prescribed practical training program have been presented to the secretary prior to the examination. An application for examination by the board may be denied if the applicant is proven to have been involved in any violation of this chapter. An applicant who has been expelled from an examination for cribbing, cheating, or other dishonest conduct shall not be permitted to complete the examination applied for and shall not be permitted to file a new application for examination during the balance of the same calendar year or the calendar year next following the expulsion. The board may issue a license without examination to an applicant who furnishes satisfactory proof that he or she has been licensed to practice pharmacy by examination in another state that under like conditions grants reciprocal licensure without examination to pharmacists duly licensed by examination in this state, that he or she is a person of good moral character and temperate habits, and provided that the requirements in the state from which the applicant is reciprocating were no less than the requirements of the National Association of Boards of Pharmacy. The application shall be accompanied by a fee set by the board. Each applicant for licensure by reciprocity shall be personally interviewed by two or more members of the board before being granted a license, and the applicant shall pass a written examination on the laws governing the practice of pharmacy in this state. The applicant shall be approved for reciprocity by the board prior to the time that he or she begins the duties of a licensed pharmacist in this state. No applicant shall be granted reciprocal licensure unless all evidence and supporting documents of licensure in the state from which the applicant is reciprocating are approved as meeting the requirements for reciprocity of the National Association of Boards of Pharmacy. The board shall set and collect a fee for submitting and certifying grades for reciprocity in other states.
(Acts 1966, Ex. Sess., No. 205, p. 231, §11; Acts 1975, 3rd Ex. Sess., No. 147, p. 393; Acts 1989, No. 89-235, p. 303, §3; Act 98-643, p. 1414, §1.)Section 34-23-52
Section 34-23-52 Expiration and renewal of certificate; continuing education.
(a) All certificates of licensure shall expire on December 31 of even-numbered years. Every licensed pharmacist in order to continue to be licensed shall pay a biennial renewal fee to be determined by the board, but the fee shall not be less than twenty-five dollars ($25) nor more than one hundred fifty dollars ($150) to the secretary of the board, the fee being due on October 31 and delinquent after December 31 of even-numbered years except, that holders of life certificates to practice pharmacy previously issued shall not be required to pay a renewal fee. The payment of the renewal fee shall entitle the registrants to renewal of their certificates at the discretion of the board. If any pharmacist shall fail to pay a renewal fee on or before the due date, the holder of the certificate may be reinstated as a licensed pharmacist only upon payment of a penalty of ten dollars ($10) for each lapsed month and all lapsed fees, provided the lapsed time of registration shall not exceed five years, in which case reinstatement may be had only upon satisfactory examination by the board.
(b) In addition to any fee requirements, each pharmacist is required to complete 15 hours of continuing education per calendar year, of which three hours shall be live presentation.
(Acts 1966, Ex. Sess., No. 205, p. 231, §13; Acts 1985, No. 85-702, p. 1151, §1; Act 2004-450, p. 801, §1.)Section 34-23-53
Section 34-23-53 Training program for candidates for licensure.
Candidates for licensure as pharmacists shall complete a practical training program as prescribed by the board in keeping with standards established by the national accreditation agencies. The candidate shall apply to the board for proper reporting forms and shall ascertain that the preceptor under whom he or she proposes to take his or her practical training is a qualified preceptor. The candidate shall receive credit for experience gained only in an approved site under the supervision of an approved preceptor. The candidate must keep records as prescribed by the board of all professional experience gained, and upon request, must report to the board and furnish information relative to the practical experience gained. The board may accept internship affidavits from other states, provided the internship requirements are no less than requirements of the National Association of Boards of Pharmacy.
(Acts 1966, Ex. Sess., No. 205, p. 231, §27; Acts 1975, 3rd Ex. Sess., No. 147, p. 393; Act 98-643, p. 1414, §1.)Section 34-23-6
Section 34-23-6 Bankruptcy sales, auction sales, etc., of drugs and medicines.
In the event of any sale in bankruptcy, at public auction or any other sale except in the normal course of business, the seller shall give written notice of such sale to the board at least one week prior to the day of sale, and a complete and accurate report must be made in writing to the board by the proposed seller within 10 days after such sale showing the names and addresses of the parties to whom any narcotics, exempt narcotics or dangerous drugs have been sold together with an itemized inventory thereof. This section shall not apply to the bona fide sale of a pharmacy as a business when the board has been notified of such proposed sale.
(Acts 1966, Ex. Sess., No. 205, p. 231, §30.)Section 34-23-7
Section 34-23-7 Illegal possession of prescription drugs.
Any person found in possession of a drug or medicine limited by law to dispensation by a prescription, unless such drug or medicine was lawfully dispensed, shall be guilty of a misdemeanor and, upon conviction, shall be fined not more than $1,000.00 and, in addition thereto, may be imprisoned in the county jail for hard labor for not more than one year. This section shall not apply to a licensed pharmacy, licensed pharmacist, wholesaler, manufacturer or his representative acting within the line and scope of his employment, physician, veterinarian, dentist or nurse acting under the direction of a physician, nor to a common carrier or messenger when transporting such drug or medicine in the same unbroken package in which the drug or medicine was delivered to him for transportation.
(Acts 1966, Ex. Sess., No. 205, p. 231, §31.)Section 34-23-70
Section 34-23-70 Management; display of permit and license; poisons; prescriptions generally; physicians not restricted by chapter.
(a) Every pharmacy when opened for business shall be under the personal supervision of a duly licensed pharmacist who shall have personal supervision of not more than one pharmacy at the same time. During temporary absences of the licensed pharmacist, not to exceed three hours daily or more than one and one-half hours at any one time, nor more than one week for temporary illness, the prescription department shall be closed, and no prescriptions are to be filled. During the temporary absence of a pharmacist, a sign shall be placed on the prescription counter in a prominent location easily seen by the public stating, 'Prescription Department Closed, No Pharmacist on Duty.'
(b) The permit issued to each pharmacist by the board and the licensure certificates issued to the licensed pharmacist employed by each pharmacy must be prominently and conspicuously displayed in the pharmacy. The name of the licensed pharmacist on duty must be conspicuously displayed in the prescription department in a place readily observable by the public.
(c) No licensed pharmacist or pharmacy operating within this state shall accept for refund purposes or otherwise any unused portion of any dispensed prescription.
(d) The sale of poisons is restricted to the immediate supervision of a licensed pharmacist, and such poison shall not be displayed in a pharmacy in such a manner that a customer may obtain possession of such poisons when standing in an area allocated for customer use. No sale of a poison shall be made or delivered to any minor under 12 years of age or to any person known to be of unsound mind or under the influence of alcohol.
(e) No pharmacy shall authorize any person, firm or business establishment to serve as a pick-up station or intermediary for the purpose of having prescriptions filled or delivered, whether for profit or gratuitously.
(f) No prescription blank supplied by a pharmacy or pharmacist to a practitioner shall bear the imprint thereon of the name or address of any pharmacy or bear the name or address of any person registered under this chapter.
(g) No person shall fill or compound a prescription or drug order in an institution unless he is a duly licensed pharmacist or otherwise permitted to do so under the provisions of this chapter. The act of filling or compounding prescriptions or drug orders in an institution shall be as defined in the rules and regulations adopted by the board of pharmacy.
However, such rules and regulations shall not apply to the reading, interpreting and writing or verifying the writing of adequate directions as are necessary to assure patient's understanding of the prescriber's intentions by a duly qualified nurse practicing her/his profession in a licensed hospital or similar institution.
Nothing in this chapter shall authorize the Board of Pharmacy to promulgate or to enforce any rule or regulation which governs, regulates or restricts the professional practice of a physician licensed to practice medicine in this state. No provision of this chapter, or any rule promulgated under the authority of this chapter shall be interpreted to amend, alter or modify the provisions of Section 34-23-11.
(h) Only a licensed pharmacist or registered intern may accept an oral prescription of any nature. Upon so accepting such oral prescription, it must immediately be reduced to writing, and only a licensed pharmacist or an intern supervised by a licensed pharmacist may prepare a copy of a prescription or read a prescription to any person for purposes of providing reference concerning treatment of the person or animal for whom the prescription was written; and, when said copy is given, a notation shall be made upon the prescription that a copy has been given, the date given and to whom given.
(i) If a prescription is refilled, a record of the date upon which the prescription is refilled must appear on the prescription or in a permanent prescription record book. On prescriptions which may be refilled, written or oral authorization must be received before refilling unless the number of refills is indicated on the original prescription. Those prescriptions marked 'refill prn' or equivalent designation shall be refilled only in quantities commensurate with the dosage scheduled.
(j) Each prescription must be written in a manner so that it can be compounded by any registered pharmacist. The coding of any prescription is in violation of this chapter. No prescription shall be written in any characters, figures or ciphers, other than in the English or Latin language, generally in use among medical and pharmaceutical practitioners.
(k) A prescription file or files shall be kept by every pharmacy for a period of not less than two years in which the original of every prescription compounded or dispensed shall be filed in the order of compounding with number and date of dispensing placed on each prescription. Each pharmacy shall produce any prescription file whenever legally required to do so. Such prescription file shall at all times be open for inspection by the prescriber, the board of pharmacy or its inspectors.
(l) All drugs or drug preparations bearing upon the package the words, 'caution, federal law prohibits dispensing without prescription' or words to the same effect, otherwise known as 'legend drugs,' shall be stored within the confines of the prescription department or the prescription department storage room of each pharmacy. Such drugs shall be sold or dispensed only on the prescription of a licensed practitioner authorized to prescribe such drugs and shall not be sold or dispensed as a refilled prescription except upon the express authorization of the prescriber. This shall not be construed to prohibit return to authorized suppliers or sale or transfer to others licensed to possess legend drugs.
(m) Any person who violates any of the provisions of this section shall be guilty of a misdemeanor.
(Acts 1966, Ex. Sess., No. 205, p. 231, §15; Acts 1989, No. 89-747, p. 1513, §1.)Section 34-23-71
Section 34-23-71 Requirements for prescription rooms.
Any new pharmacy or any existing pharmacy which is to be remodeled or which is to be moved to a new location other than a hospital pharmacy must comply with the following requirements for the prescription room area: That portion or part of the entire licensed pharmacy which is to be occupied by the prescription compounding or dispensing department, including that portion or part thereof utilized for the sale of restricted drugs, shall be not less than 240 square feet. The surface of the prescription compounding counter shall be not less than 24 inches in 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 two or more pharmacists are to be on duty at any one time. The aisle space or floor area to be occupied by a dispensing pharmacist shall extend the full length of the prescription compounding counter, and it shall be clear and unobstructed for a minimum distance of 36 inches from the working side of the prescription compounding counter.
(Acts 1966, Ex. Sess., No. 205, p. 231, §16.)Section 34-23-72
Section 34-23-72 Internship training sites.
Every site approved by the State Board of Pharmacy for intern training shall be managed so that the intern is provided with ample opportunity to meet the training requirements established by the board. The site must have in its employ, or have an arrangement with, a pharmacist who is registered as a preceptor. A site which meets these qualifications may be approved for internship training by the board.
(Acts 1966, Ex. Sess., No. 205, p. 231, §25; Act 98-643, p. 1414, §1.)Section 34-23-73
Section 34-23-73 Preceptor qualifications.
Every pharmacist serving as a preceptor shall have expressed a willingness to serve as a preceptor. Pharmacist preceptors shall be approved by the board and shall be willing to cooperate with the board in developing the necessary training requirements and shall provide appropriate documentation to the board. Each preceptor shall certify as to the commencement and completion of the training period and may make recommendations to the board concerning the competency of his or her trainee. The preceptor shall report to the board from time to time as requested on the progress of any intern or extern under his or her supervision. It shall be his or her responsibility in a supervisory capacity to see that each intern or extern receives proper training under the objectives of the board for this practical training program.
(Acts 1966, Ex. Sess., No. 205, p. 231, §26; Act 98-643, p. 1414, §1.)Section 34-23-74
Section 34-23-74 Hospitals and related institutions.
Every pharmacy located in a hospital, skilled nursing home, or other related institution in this state shall be under the supervision of a licensed pharmacist. In general hospitals, skilled nursing homes, and extended care facilities not operating a pharmacy, the drug or medicine room shall be under the direct supervision and direction of a consulting pharmacist or a member of the medical staff who shall be a licensed practitioner of medicine. In nursing homes which are not classified by the State Board of Health as skilled nursing homes, maternity homes, homes for the aged, domiciliary institutions, and all related institutions except those operated by and in conjunction with a licensed hospital, medicines or drugs bearing the wording on the label 'caution, federal law prohibits dispensing without prescription' or similar wording that causes the medicines or drugs to be known as prescription legend drugs shall be furnished by a licensed pharmacy on the prescription of a licensed practitioner of medicine for individual patients, and there shall be no prescription legend drugs on the premises of these institutions other than those so prescribed except an emergency kit as authorized by the State Board of Health. In hospitals and skilled nursing homes using vending machines or mechanical devices for the storage and dispensing of drugs, the machines or devices shall be stocked only under the supervision of a licensed pharmacist, and the drugs may be dispensed from the machine or device only by an individual acting in accordance with established institutional hospital pharmacy policy. The State Board of Pharmacy may at any time adopt such additional rules and regulations consistent with this chapter as may be deemed necessary after advising with the Alabama Society of Hospital Pharmacists in regard to the storage and handling of drugs and medicines and the disposition of unused portion of drugs and medicines in hospitals and other related institutions under this section.
(Acts 1966, Ex. Sess., No. 205, p. 231, §28; Acts 1995, No. 95-398, p. 819, §1.)Section 34-23-75
Section 34-23-75 Emergency prescription refill.
In the event a pharmacist receives a request for a prescription refill 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, providing that:
(1) The prescription is not a medicinal agent listed in Schedule II appearing in Title 20, Chapter 2.
(2) The medication is essential to the maintenance of life or the continuation of therapy in a chronic condition. Only those drugs designated by a joint rule adopted by the board of pharmacy and board of medical examiners shall be refilled, according to the procedure established in this section.
(3) The dispensing pharmacist creates a written order containing all of the prescription information required by this chapter and Title 20, Chapter 2.
(4) The dispensing pharmacist notifies the prescriber of the emergency dispensing within 72 hours after such dispensing.
(Acts 1991, No. 91-554, p. 1023, §1.)Section 34-23-8
Section 34-23-8 Substitution of drugs or brands of drugs.
No person shall dispense or cause to be dispensed a different drug or brand of drug in lieu of that ordered or prescribed without the express permission in each case of the person ordering or prescribing such drug, except as provided below:
(1) A licensed pharmacist in this state shall be permitted to select for the brand name drug product prescribed by a licensed physician or other practitioner who is located in this state and authorized by law to write prescriptions, hereinafter referred to as 'practitioner,' a less expensive pharmaceutically and therapeutically equivalent drug product containing the same active ingredient, or ingredients, and of the same dosage form strength, in all cases where the practitioner expressly authorizes such selection in accordance with subdivision (4) of this section.
(2) A licensed pharmacist located in this state shall be permitted to select for the brand name drug product prescribed by a practitioner who is located in another state or licensing jurisdiction and who is authorized by the laws of that state or jurisdiction to write prescriptions, a less expensive pharmaceutically and therapeutically equivalent drug product containing the same active ingredient or ingredients, and of the same dosage form strength, in all cases where the out-of-state licensed physician or other practitioner does not expressly prohibit a substitution.
(3) A pharmacist shall record on the prescription form the name and manufacturer or distributor of any drug product dispensed as herein authorized.
(4) Every written prescription issued in this state by a licensed practitioner shall contain two signature lines. Under one signature line shall be printed clearly the words 'dispense as written.' Under the other signature line shall be printed clearly the words 'product selection permitted.' The practitioner shall communicate instructions to the pharmacist by signing on the appropriate line. The State Board of Pharmacy shall not promulgate any rule or regulation affecting the subject matter of this subdivision.
An oral prescription from the practitioner shall instruct the pharmacist whether or not a less expensive pharmaceutically and therapeutically equivalent drug product may be dispensed. The pharmacist shall note instructions on the file copy of the prescription and retain the prescription form for the period specified by law.
(5) Unless otherwise indicated by the practitioner, the prescription label on the dispensing container shall indicate the actual drug product dispensed, either the brand name, or if none, the generic name; and the name of the manufacturer or a reasonable abbreviation of the name of the manufacturer.
(6) This shall not be interpreted to exclude the use of a formulary or drug list as adopted and approved by a medical staff in a licensed hospital with drugs provided thereunder by procedures established for use within that licensed hospital.
(7) Any person who violates the provisions of this section shall be punished by a fine of up to $1,000.
(Acts 1966, Ex. Sess., No. 205, p. 231, §18, Acts 1979, No. 79-429, p. 676, §1; Act 2002-58, p. 144, §1.)Section 34-23-9
Section 34-23-9 Purity of drugs dispensed.
No person shall compound or sell or offer for sale or cause to be compounded, sold or offered for sale any medicine, drug, poison, chemical or pharmaceutical preparation that is adulterated. Any one of the above-named substances shall be deemed to be adulterated if it is sold by a name recognized in the United States Pharmacopoeia or National Formulary and it differs from the standard of strength, quality or purity as determined by the test laid down therein unless the label so clearly states, or if its strength, quality or purity shall fall below the professed standard of strength, quality or purity under which it is sold. The board shall examine into any claimed adulteration by using the services of an analyst or chemist of recognized approved standing. Any person violating the provisions of this section shall be guilty of a misdemeanor.
(Acts 1966, Ex. Sess., No. 205, p. 231, §17.)Section 34-23-90
Section 34-23-90 Composition; qualifications of members; appointment; election; vacancies; term of office; removal of members; oath of office; election of officers.
(a) The Alabama State Board of Pharmacy is vested with the authority to carry out the purposes of and enforce this chapter. The board shall consist of five members. The members of the board shall be licensed pharmacists who have been licensed in this state for a minimum of five years and who are actively engaged in the practice of pharmacy or pharmacy administration, or both.
(b) Three members shall be appointed by the Governor. Of the three appointed members, one member shall be engaged in the practice of pharmacy, or pharmacy administration, or both, in a hospital, one in an independent pharmacy, and one in a chain pharmacy. On or before August 1, 1996, and each five years thereafter, or whenever a vacancy occurs in the designated position for hospital pharmacists, the Alabama Society of Health System Pharmacists, or its successor organization, shall submit a list of three nominees to the Governor. On or before August 1, 1994, and each five years thereafter, or whenever a vacancy occurs in the designated position for a chain pharmacist, the Alabama Pharmacy Association, or its successor organization, shall submit a list of three nominees to the Governor. On or before August 1, 1997, and each five years thereafter, or whenever a vacancy occurs in the designated position for the independent pharmacist, the independent pharmacist members of the Alabama Pharmacy Association, or its successor organization, shall submit a list of three nominees to the Governor. From the names submitted to the Governor, the Governor shall appoint a replacement on or before December 31 of the same year the nominations are received, for the member or members whose term or terms are expiring. Background information shall be provided for each nominee for an appointed position.
(c) On or before December 1, 1995, and each five years thereafter, and on or before December 1, 1998, and each five years thereafter, or whenever a vacancy occurs in a nondesignated position, the Board of Trustees of the Alabama Pharmacy Association, or its successor organization, shall select a committee of five pharmacists who are members of the association to serve as a nominating committee. No one on the committee shall be a candidate. The committee shall receive names of pharmacists actively engaged in pharmacy practice or administration, or both, from companies and individuals, and shall narrow the list of nominees to two names to be placed on a ballot to be voted on by all Alabama pharmacists. The election procedure for a nondesignated slot shall be as follows: Each candidate shall provide a biographical sketch of not more than 150 words, which shall include his or her most recent practice experience. The board shall mail election ballots and a biographical sketch of the candidates to Alabama licensed pharmacists by September 1. Completed ballots returned to the board postmarked by October 1 shall be tabulated. A pharmacist receiving a majority of the ballots received shall be considered the winner. If a runoff election is necessary, the runoff ballots shall be mailed to licensed pharmacists by November 1 and returned postmarked by December 1. A canvassing committee consisting of a representative from the Alabama Pharmacy Association, or its successor organization, Alabama Society of Health System Pharmacists, or its successor organization, Auburn University School of Pharmacy, and Samford University School of Pharmacy shall tabulate the ballots.
(d) Any vacancies occurring on the board other than by expiration of term shall be filled by election or appointment only for the unexpired term and shall be filled by the same procedure that the replaced member was elected or appointed. Each member of the board shall serve a term of five years beginning on January 1 following appointment and terminating on December 31 of his or her fifth year as a member of the board.
(e) No pharmacist shall serve two full terms consecutively.
(f) The Governor, upon recommendation of the board, may remove a member of the board upon proven charges of inefficiency, incompetency, immorality, or professional misconduct. The replacement member shall be elected or appointed by the same procedure that the removed member was elected or appointed. Appointees to the board shall within 30 days after their appointment or election take an oath or make affirmation before a properly qualified officer that they will faithfully and impartially perform the duties of their office. This oath or affirmation shall be filed with the Secretary of State. At its last regular meeting in each calendar year, the board shall organize by electing for a term of one year, effective the following January 1, a president, a vice-president, and a treasurer who shall be members of the board. No member shall serve more than two years in the same office on the board during a five-year term. The board shall also elect a secretary who shall not serve as a member of the board and the board shall have the authority to fix the amount of the secretary's remuneration. If a board member is selected as secretary, the board member shall resign from the board and a replacement on the board shall be selected by the same procedure by which the resigned member was originally elected or appointed. The secretary shall not be employed during the service by any registrant of the board.
(g) For the purpose of this section, a chain pharmacy shall be defined as any retail pharmacy employing in Alabama a minimum of 40 full-time equivalent pharmacists. A chain pharmacist is defined as a pharmacist employed on a full-time basis by a chain pharmacy for a minimum of three years.
(h) It is the intent of the Legislature that the composition of the board reflect the demographics of the pharmacy profession.
(Acts 1966, Ex. Sess., No. 205, p. 231, §3; Acts 1981, No. 81-810, p. 1448, §1; Acts 1989, No. 89-235, p. 303, §3; Acts 1993, No. 93-671, p. 1209, §3; Act 2001-247, p. 293, §3.)Section 34-23-91
Section 34-23-91 Duties of officers; bonds of secretary and treasurer; compensation and expenses; meetings; quorum; funds and disbursements; books and records.
The president of the board shall preside at all of the board's meetings. The vice-president shall preside in the absence or inability of the president. The secretary of the board shall be the executive officer in charge of the board's office. The secretary shall make, keep, and be in charge of all records and record books required to be kept by the board, including a register containing all information which shall be required under this chapter. The secretary shall attend to the correspondence of the board and perform any other duties the board may require in keeping with the office of secretary. The secretary shall receive and record all fees collected under this chapter and, at regular intervals as ordered by the board, shall pay the fees to the treasurer of the board for its use. The secretary may have any forms printed and office supplies furnished as necessary to implement this chapter. The secretary and treasurer of the board shall each furnish bond in an amount to be fixed by the board and shall be conditioned upon the faithful performance and discharge of their respective official duties. The members of the board shall be paid the same per diem and travel allowance as is paid by law to state employees while engaged in the performance of the duties of the board, in addition to any daily compensation or allowance determined by the board. The board shall conduct meetings at least three times annually and more often when deemed necessary for the examination of applicants for licensure and for the transaction of business as may legally come before it. Public notice of all stated meetings shall be given at least 30 days in advance of the meetings. At all meetings of the board, a majority shall constitute a quorum. The members of the board shall determine the place of meetings of the board. The treasurer of the board shall have custody of all funds derived from the various provisions of this chapter. All disbursements shall be made by check as authorized by vouchers signed by the president and secretary of the board. The books and records of the board as made and kept by the secretary or under his supervision shall be prima facie evidence of the matter therein recorded in any court.
(Acts 1966, Ex. Sess., No. 205, p. 231, §4; Acts 1971, No. 1952, p. 3171, §1; Acts 1989, No. 89-235, p. 303, §3; Acts 1993, No. 93-671, p. 1209, §3.)Section 34-23-92
Section 34-23-92 Powers and duties generally.
The board shall exercise, subject to the provisions of this chapter, the following powers and duties:
(1) To adopt rules concerning the records and reports to be kept and made by a pharmacy relating to the filling of prescriptions and the handling and preservation of drugs.
(2) To fix standards and requirements for licenses and permits except as otherwise specified in this chapter.
(3) To make rules and regulations regarding sanitation consistent with state health regulations.
(4) To employ such chemists, agents, clerical help and attorneys necessary for the proper administration of the duties of the board.
(5) To employ a Chief Drug Inspector and other drug inspectors not to exceed six that it deems necessary to enforce the provisions of this chapter which are under the supervision of the board.
(6) To adopt rules and regulations for the administration and enforcement of this chapter and not inconsistent herewith. Such rules and regulations shall be referenced to the section or sections of this chapter which set forth the legislative standard which it interprets or to which it applies. Every such rule and regulation shall be adopted in accordance with the Alabama Administrative Procedure Act. A copy of every rule and regulation containing a requirement of general application shall be mailed to each registered pharmacist at least 10 days before the effective date thereof. The failure of a registered pharmacist to receive a copy of such rule or regulation shall not exempt him from the duty of compliance with the valid rules and regulations lawfully issued.
(7) To investigate violations of this chapter or any other law pertaining to the practice of pharmacy that may come to the knowledge of the board and institute or cause to be instituted before the board or in a proper court appropriate proceedings in connection therewith.
(8) To issue subpoenas and compel the attendance of witnesses and the production of all necessary papers, books and records, documentary evidence and materials or other evidence in matters pending before the board relating to the revocation, suspension or probation of any license. Those persons issued subpoenas and compelled to attend hearings or meetings in matters pending before the board of pharmacy shall be entitled to witness fees from board of pharmacy funds. Claims for witness fees shall be made on accepted State of Alabama voucher forms as appropriate. Travel and mileage expenses shall be reimbursed to witnesses in the amounts officially authorized to the board and its personnel at the time the service to the Board of Pharmacy is performed.
(9) The members of the board shall have the power and authority to administer oaths in connection with the duties of the board.
(10) The board shall make a written report annually of its receipts and disbursements to the Governor and to the State Pharmaceutical Association. Included in this report shall be the names of all registrants licensed to practice under this chapter and a record of all permits issued during the period covered by the report.
(11) It shall be the duty of the board to enforce the provisions of the state barbiturate act, the state amphetamine act, the state narcotic law and all other laws of the state which pertain to the practice of pharmacy, the examination of applicants, the licensing of pharmacists, the manufacture, packaging, repackaging, production, sale or distribution of drugs, chemicals and poisons, and all laws pertaining to standards for their strength and purity. The board may work in conjunction with other law-enforcement agencies to enforce the provisions of any law pertaining to the practice of pharmacy. Nothing in this section shall be construed to deprive the state board of health of any powers or duties otherwise prescribed by law including the enforcement of the narcotic law.
(12) It shall be the duty of the board to investigate alleged violations of this chapter or any rule or regulation published by the board and conduct hearings to revoke, suspend or probate any license or permit granted by the board under the provisions of this chapter and to invoke penalties not to exceed the sum of $1,000.00 for each such violation(s) and to institute any legal proceedings necessary to effect compliance with this chapter; provided, that any person, firm or corporation subjected to such penalty or legal proceedings may take an appeal in accordance with the provisions of Section 34-23-94.
(13) On application of any person and payment of the cost therefor, the secretary of the board shall furnish, under its seal and signed by him, a certified copy of his license or permit, regulation or rule. In any court or proceeding, such copy shall be prima facie evidence of the fact of the issuance of such permit or license and the adoption of such rule or regulation.
(Acts 1966, Ex. Sess., No. 205, p. 231, §5; Acts 1989, No. 89-235, p. 303, §3.)Section 34-23-93
Section 34-23-93 Assisting prosecuting officers; legal counsel.
The board and its members and officers shall assist prosecuting officers in the enforcement of this chapter, and it shall be the duty of the board, its members and officers to furnish the proper prosecuting officers with such evidence as it or they may ascertain to assist them in the prosecution of any violation of this chapter, and the board is authorized for such purposes to make such reasonable expenditures from the funds of the board as it may deem necessary to ascertain and furnish such evidence. The Attorney General of the state shall be the attorney for the board, but the board may in its discretion employ other counsel. It shall be the duty of the district attorney of the judicial circuit wherein any offense is committed to prosecute violations of this chapter.
(Acts 1966, Ex. Sess., No. 205, p. 231, §6.)Section 34-23-94
Section 34-23-94 Judicial review of orders.
From any order of the board any party affected thereby may appeal such ruling to the circuit court of the county where the party aggrieved resides. The notice of appeal shall be filed within 30 days from the receipt of such order or ruling. Appeals shall be governed by the judicial review provisions of the Alabama Administrative Procedure Act.
(Acts 1966, Ex. Sess., No. 205, p. 231, §22; Acts 1985, 2nd Ex. Sess., No. 85-1002, p. 380.)
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