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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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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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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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34-21-81
Section 34-21-81 Definitions. As used in this article, the following terms shall have
the following meanings: (1) BOARD OF MEDICAL EXAMINERS. The State Board of Medical Examiners
established pursuant to Section 34-24-53. (2) BOARD OF NURSING. The Board of Nursing
established under Section 34-21-2. (3) ADVANCED PRACTICE NURSE. A registered nurse
that has gained additional knowledge and skills through successful completion of an organized
program of nursing education that prepares nurses for advanced practice roles and has been
certified by the Board of Nursing to engage in the practice of advanced practice nursing.
There shall be four categories of advanced practice nurses: Certified registered nurse practitioners
(CRNP), certified nurse midwives (CNM), certified registered nurse anesthetists (CRNA), and
clinical nurse specialists (CNS). Certified registered nurse practitioners and certified nurse
midwives are subject to collaborative practice agreements with an Alabama physician....
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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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34-23-160
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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27-45A-3
Section 27-45A-3 Definitions. For purposes of this chapter, the following words shall
have the following meanings: (1) CLAIMS PROCESSING SERVICES. The administrative services performed
in connection with the processing and adjudicating of claims relating to pharmacist services
that include any of the following: a. Receiving payments for pharmacist services. b. Making
payments to pharmacists or pharmacies for pharmacist services. c. Both paragraphs a. and b.
(2) OTHER PRESCRIPTION DRUG OR DEVICE SERVICES. Services, other than claims processing services,
provided directly or indirectly, whether in connection with or separate from claims processing
services, including without limitation any of the following: a. Negotiating rebates, discounts,
or other financial incentives and arrangements with drug companies. b. Disbursing or distributing
rebates. c. Managing or participating in incentive programs or arrangements for pharmacist
services. d. Negotiating or entering into contractual...
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26-23E-3
Section 26-23E-3 Definitions. As used in this chapter, the following terms shall have
the following meanings: (1) ABORTION. The use or prescription of any instrument, medicine,
drug, or any other substance or device with the intent to terminate the pregnancy of a woman
known to be pregnant with knowledge that the termination by those means will with reasonable
likelihood cause the death of the unborn child. Such use or prescription is not an abortion
if done with the intent to save the life or preserve the health of an unborn child, remove
a dead unborn child, or to deliver the unborn child prematurely in order to preserve the health
of both the mother (pregnant woman) and her unborn child. The term abortion as used in this
chapter, does not include a procedure or act to terminate the pregnancy of a woman with an
ectopic pregnancy, nor does it include the procedure or act to terminate the pregnancy of
a woman when the unborn child has a lethal anomaly. For the purposes of this chapter,...
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20-2-58
Section 20-2-58 Dispensing of controlled substances in Schedule II; maintenance of records
and inventories by registered pharmacies. (a) Except as otherwise provided in this section
or as otherwise provided by law, a pharmacist may dispense directly a controlled substance
in Schedule II only pursuant to a written prescription signed by the practitioner. Except
as provided in subsections (b) and (c), a prescription for a Schedule II controlled substance
may be transmitted by the practitioner or the agent of the practitioner to a pharmacy via
facsimile equipment; provided, the original written, signed prescription is presented to the
pharmacist for review prior to the actual dispensing of the controlled substance. (b) A prescription
written for a Schedule II narcotic substance to be compounded for the direct administration
to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion
may be transmitted by the practitioner or the agent of the practitioner...
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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...
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