Code of Alabama

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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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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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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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34-23-1
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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34-23-70
Section 34-23-70 Management; display of permit and license; poisons; prescription requirements;
violations. (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....
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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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20-2-188
Section 20-2-188 Exceptions to requirements for sale or transfer of chemicals, and to licensing
requirements. (a) The provisions of this article shall not apply to the sale or transfer of
products which include a listed precursor chemical if the product may be sold lawfully with
a prescription or over the counter without a prescription under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Section 301 et seq.), or under a rule adopted pursuant to that act.
(b) Notwithstanding any other provision of this article, no person shall be required to obtain
a listed precursor license or permit for the sale, receipt, transfer, manufacture, or possession
of a listed precursor chemical when: (1) Such person is a duly licensed physician, dentist,
veterinarian, podiatrist, or pharmacist, when the sale, receipt, transfer, manufacture, or
possession of such listed precursor chemical is a transaction otherwise lawfully authorized;
(2) A domestic lawful distribution in the usual course of business...
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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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16-25A-18
Section 16-25A-18 Generic equivalent medications. As a condition of participation in the Public
Education Employees Health Insurance Programs (PEEHIP), a pharmacist shall dispense a generic
equivalent medication to fill a prescription for a patient covered by PEEHIP when one is available
unless the physician indicates in longhand writing on the prescription, indicates by mark
or signature in the appropriate place on the prescription, or indicates in an electronic prescription,
the following: "medically necessary" or "dispense as written" or "do
not substitute". The generic equivalent drug product dispensed shall be pharmaceutically
and therapeutically equivalent and contain the same active ingredient or ingredients, and
shall be of the same dosage, form, and strength. (Act 2002-266, p. 549, §1; Act 2016-304,
§1.)...
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