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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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34-23-157
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...
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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). (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...
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34-23-1
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 and all substances and preparations other than food intended
to affect the structure or any function of the body of man or animal. (7) EXTERN. A
candidate for licensure as a pharmacist during the time prior to graduation from an accredited
college of pharmacy. (8) 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...
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34-23-70
of this chapter, shall be interpreted to amend, alter, or modify 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 the 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...
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34-23-184
Section 34-23-184 Audit procedures; report. (a) The entity conducting an audit shall follow
these procedures: (1) The pharmacy contract shall identify and describe in detail the audit
procedures. (2) The entity conducting the on-site audit shall give the pharmacy written notice
at least two weeks before conducting the initial on-site audit for each audit cycle. If the
pharmacy benefit manager does not include their auditing guidelines within their provider
manual, then the notice must include a documented checklist of all items being audited and
the manual, including the name, date, and edition or volume, applicable to the audit and auditing
guidelines. For on-site audits a pharmacy benefit manager shall also provide a list of material
that is copied or removed during the course of an audit to the pharmacy. The pharmacy benefit
manager may document this material on either a checklist or on an audit acknowledgement form.
The pharmacy shall produce any items during the course of the...
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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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34-23-151
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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