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...
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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 patient. 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 34-23-158. 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)...
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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...
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40-23-4
Section 40-23-4 Exemptions. (a) There are exempted from the provisions of this division and from the computation of the amount of the tax levied, assessed, or payable under this division the following: (1) The gross proceeds of the sales of lubricating oil and gasoline as defined in Sections 40-17-30 and 40-17-170 and the gross proceeds from those sales of lubricating oil destined for out-of-state use which are transacted in a manner whereby an out-of-state purchaser takes delivery of such oil at a distributor's plant within this state and transports it out-of-state, which are otherwise taxed. (2) The gross proceeds of the sale, or sales, of fertilizer when used for agricultural purposes. The word "fertilizer" shall not be construed to include cottonseed meal, when not in combination with other materials. (3) The gross proceeds of the sale, or sales, of seeds for planting purposes and baby chicks and poults. Nothing herein shall be construed to exempt or exclude from the computation of...
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40-23-1
Section 40-23-1 Definitions; transactions considered or not considered sales. (a) For the purpose of this division, the following terms shall have the respective meanings ascribed by this section: (1) PERSON or COMPANY. Used interchangeably, includes any individual, firm, copartnership, association, corporation, receiver, trustee, or any other group or combination acting as a unit and the plural as well as the singular number, unless the intention to give a more limited meaning is disclosed by the context. (2) DEPARTMENT. The Department of Revenue of the State of Alabama. (3) COMMISSIONER. The Commissioner of Revenue of the State of Alabama. (4) TAX YEAR or TAXABLE YEAR. The calendar year. (5) SALE or SALES. Installment and credit sales and the exchange of properties as well as the sale thereof for money, every closed transaction constituting a sale. Provided, however, a transaction shall not be closed or a sale completed until the time and place when and where title is transferred by...
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40-23-60
Section 40-23-60 Definitions. For the purpose of this article, the following terms shall have the respective meanings ascribed to them in this section: (1) PERSON or COMPANY. Any individual, firm, company, partnership, association, corporation, receiver or trustee, or any other group or combination acting as a unit, and the plural as well as the singular number, unless the intention to give a more limited meaning is disclosed by the context. (2) DEPARTMENT. The Department of Revenue of the State of Alabama. (3) COMMISSIONER. The Commissioner of Revenue of the State of Alabama. (4) WHOLESALE SALE or SALE AT WHOLESALE. Any one of the following: a. A sale of tangible personal property by wholesaler to licensed retail merchants, jobbers, dealers or other wholesalers for resale and does not include a sale by wholesalers to users or consumers, not for resale. b. A sale of tangible personal property or products, including iron ore, and including the furnished container and label of such...
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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) BIOLOGICAL PRODUCT. Has the same meaning as the term as defined in 42 U.S.C. §262. (3) BOARD or STATE BOARD. The Alabama State Board of Pharmacy. (4) 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. (5) DISPENSE. To sell, distribute, administer, leave with, give away, dispose of, deliver, or supply a drug or medicine to the ultimate user or his or her agent. (6) 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...
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20-2-190
Section 20-2-190 Penalties; sale of ephedrine, etc.; Alabama Drug Abuse Task Force. (a) Any person who manufactures, sells, transfers, receives, or possesses a listed precursor chemical violates this article if the person: (1) Knowingly fails to comply with the reporting requirements of this article; (2) Knowingly makes a false statement in a report or record required by this article or the rules adopted thereunder; (3) Is required by this article to have a listed precursor chemical license or permit, and is a person as defined by this article, and knowingly or deliberately fails to obtain such a license or permit. An offense under this subsection shall constitute a Class C felony. (b) Notwithstanding the provisions of Section 20-2-188, a person who possesses, sells, transfers, or otherwise furnishes or attempts to solicit another or conspires to possess, sell, transfer, or otherwise furnish a listed precursor chemical or a product containing a precursor chemical or ephedrine or...
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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 patient after professional interaction or consultation between the pharmacist and the patient. 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, p. 1094, §10; Act 2017-422, §1)...
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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...
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