reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2457 - Standards of Practice

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Environmental Standards
1. The prescription
				  department shall be of sufficient size commensurate with the nature and scope
				  of practice. The space occupied by the prescription department shall be
				  restricted to authorized personnel only, as determined by the
				  pharmacist-in-charge, and shall not be accessible to the general public. A
				  marijuana pharmacy shall not permit any person less than eighteen years of age
				  to enter the prescription department, with the exception of patients being
				  counseled by the pharmacist.
2. The
				  prescription department shall contain sufficient fixtures, equipment, and
				  supplies commensurate with the nature and scope of practice for that
				  pharmacy.
3. The prescription
				  department shall include a sink with a hot and cold water supply, exclusive of
				  restroom facilities, with approved sewage disposal.
4. All areas where drugs and devices are
				  stored shall be dry, well-lighted, well-ventilated, and maintained at
				  temperatures which will ensure the integrity of drugs during their storage and
				  prior to their dispensing as stipulated by the
United States
				  Pharmacopeia
and/or manufacturers or distributors product labeling
				  unless otherwise indicated by the board.
5. The prescription department shall be
				  secured by one or more physical barriers with suitable locks and a monitored
				  alarm system capable of detecting unauthorized entry.
6. Prescription and other patient healthcare
				  information shall be maintained in a manner that protects the integrity and
				  confidentiality of such information.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 24 - Limited Service Providers › Subchapter E - Marijuana Pharmacy › Section LIII-2459 - Advertising (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 40:1046.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter A - General Requirements › Section LIII-2501 - Prescription Drugs and Devices

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Prescription Drugs or Devices. A prescription drug or device is a medication or
				  mechanism that may only be dispensed by a pharmacist on the order of a licensed
				  practitioner and shall bear the "Rx Only" notation or any other designation of
				  similar import required by law on the label of a commercial container.
1. Dispensing. Prescription drugs or devices
				  shall be dispensed only by a Louisiana-licensed pharmacist.
2. Possession. Prescription drugs or devices
				  shall be procured and possessed in the course of the practice of pharmacy by a
				  permitted pharmacy.
3. Storage.
				  Prescription drugs or devices shall be stored in a permitted pharmacy under the
				  immediate control and responsibility of a pharmacist.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter A - General Requirements › Section LIII-2503 - Drug Returns; Drug Disposal

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless otherwise allowed by law, drugs
				  dispensed on prescription to a patient shall not be accepted for return,
				  exchange, or re-dispensing by any pharmacist or pharmacy after such drugs have
				  been removed from the pharmacy premises where they were dispensed.
B. When a patient or his designee wishes to
				  return previously dispensed prescription drugs to a pharmacy for disposal, the
				  pharmacy shall inform the patient or his designee of the disposal mechanisms
				  available to him. In the event the pharmacy elects to accept such previously
				  dispensed products for disposal, the pharmacy shall comply with the following
				  requirements.
1. From the time of receipt of
				  such products until the time of disposal, the pharmacy shall quarantine such
				  products to keep them separate from its active dispensing stock and shall take
				  appropriate security measures to prevent the theft or diversion of such
				  products.
2. The pharmacy shall
				  comply with the provisions of  21 CFR § 1317  or its successor for the pharmacy's
				  disposal of controlled substances and other non-hazardous waste
				  pharmaceuticals.
3. The pharmacy
				  shall comply with the provisions of  40 CFR § 261  or its successor for the
				  pharmacy's disposal of hazardous waste pharmaceuticals.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter A - General Requirements › Section LIII-2505 - Investigational Drugs

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  pharmacist shall conduct, participate in, and support medical and
				  pharmaceutical research appropriate to the goals, objectives, and resources of
				  the facility.
B. The pharmacist
				  shall ensure the development of policies and procedures for the appropriate use
				  of investigational drugs; such policies shall be consistent with the applicable
				  federal rules pertaining to investigational drugs.
1. The use of investigational drugs shall be
				  authorized by the principal investigator, or his authorized
				  clinician.
2. The pharmacist shall
				  ensure the development of a central repository for the acquisition and
				  maintenance of essential information and the dissemination of that information
				  to all personnel tasked with procurement, storage, dispensing, or
				  administration of investigational drugs.
3. The pharmacist shall retain a copy of the
				  research protocol in the pharmacy; the dispensing pharmacist shall review the
				  protocol prior to dispensing the investigational drug.
4. The dispensing label for investigational
				  drugs shall comply with the provisions of this Chapter; in addition, the label
				  shall bear the phrase "For Investigational Use Only" or a similar
				  caution.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter A - General Requirements › Section LIII-2507 - Veterinary Prescription Drugs

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Veterinary prescription drugs are prescription medications for animal use
				  prescribed by a licensed veterinarian pursuant to a valid
				  veterinarian-client-patient relationship and dispensed by a licensed pharmacist
				  to the veterinarian's client, for a legitimate medical purpose, that are unsafe
				  for unsupervised use as defined in  21 CFR §201 . 105, or its
				  successor.
B. Dispensing
				  Requirements. Veterinary prescription drugs shall be exclusively dispensed by a
				  duly licensed pharmacist upon the order of a licensed veterinarian, unless
				  otherwise provided by law.
C.
				  Labeling Requirements. Veterinary prescription drugs shall be dispensed in an
				  appropriate container, and in addition to the labeling requirements in Chapter
				  11 of this Part, shall contain the following information:
1. the commercial label inscription "Caution:
				  Federal law restricts this drug to use by or on the order of a licensed
				  veterinarian"; and
2. the client's
				  name and patient's animal species.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter A - General Requirements › Section LIII-2509 - Prescription Devices

Current through Register Vol. 50, No. 6, June 20, 2024
A. In the
				  interest of public health, safety, and welfare, the board may, from time to
				  time, restrict the sale of certain devices to be dispensed only by a licensed
				  pharmacist after a legitimate medical need has been demonstrated. A legitimate
				  medical need includes the prevention of the transmission of communicable
				  diseases.
B. Pharmacy Device. A
				  pharmacy device is an instrument, apparatus, implement, machine, contrivance,
				  implant, in vitro reagent, or other similar or related article, including any
				  component or accessory, which is required under federal law to bear the label
				  "Caution: Federal or State law requires dispensing by or on the order of a
				  physician," and/or "Rx Only", or other designation of similar import.
1. Hypodermic Apparatus. Hypodermic means any
				  syringe, needle, instrument, device, or implement intended or capable of being
				  adopted for the purpose of administering drugs by subcutaneous, intramuscular,
				  or intravenous injection.
a. Sale. Hypodermic
				  syringes and/or needles shall be sold or distributed only by a licensed
				  pharmacist, physician, dentist, veterinarian, podiatrist, embalmer, drug
				  wholesaler, surgical supplier, or other legally authorized
				  distributor.
b. Storage. Hypodermic
				  syringes and/or needles shall be stored in the prescription department or in
				  another secure area.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2511 - Prescriptions and Chart Orders

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Definitions. As used in this Chapter, the following terms shall have the
				  meaning ascribed to them in this Section:
Chart Order
-a lawful order entered on the
					 electronic or paper chart or medical record of an inpatient or resident of an
					 institutional facility by a practitioner or his licensed healthcare designee
					 for a drug or device and shall be considered a prescription drug order provided
					 it contains the following:
1. full
				  name of the patient;
2. date of
				  issuance;
3. name, strength, and
				  dosage form of the drug prescribed;
4. directions for use;
5. name of the prescribing
				  practitioner;
6. the prescribing
				  practitioner's written or electronic signature or the written or electronic
				  signature of the practitioner's licensed healthcare designee, who shall be a
				  licensed nurse, pharmacist, or physician practicing in a long-term care
				  facility. The licensed healthcare designee shall be authorized to document a
				  chart order in the patient's medical record on behalf of the prescribing
				  practitioner pending the prescribing practitioner's signature, or to
				  communicate a prescription to a pharmacy whether telephonically, by facsimile
				  transmission, or electronically.
Electronic Prescription
-a prescription
					 generated, signed, and transmitted in electronic form, excluding electronically
					 transmitted facsimile documents.
Practice Affiliation
-repealed.
Practitioner
-an individual currently
					 licensed, registered, or otherwise authorized by the appropriate licensing
					 board to prescribe and administer drugs in the course of professional
					 practice.
Prescription or Prescription Drug Order
-an
					 order from a practitioner authorized by law to prescribe for a drug or device
					 that is patient specific and is communicated by any means to a pharmacist in a
					 permitted pharmacy, and is to be preserved on file as required by law or
					 regulation.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2513 - Prescription Receipt and Verification of Prescription Drug Orders and Chart Orders

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  receiving pharmacist is responsible for verification of the authenticity of the
				  prescription.
B. The dispensing
				  pharmacist is responsible for the accuracy of the medications or devices
				  dispensed.
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2515 - Prescriptions Based upon Electronic Questionnaires

Current through Register Vol. 50, No. 6, June 20, 2024
A. A prescription issued solely on the
				  results of answers to an electronic questionnaire, in the absence of a
				  documented patient evaluation including a physical examination, is issued
				  outside the context of a valid physician-patient relationship, and is not a
				  valid prescription.
B. If a
				  pharmacist has reasons to suspect that a prescription was authorized solely on
				  the results of an electronic questionnaire and in the absence of a documented
				  patient evaluation including a physical examination, the pharmacist shall
				  ascertain if that practitioner's standard of practice allows that practitioner
				  to authorize a prescription under such circumstances. Reasons to suspect that a
				  prescription may have been authorized in the absence of a valid
				  physician-patient relationship, or in violation of the practitioner's standard
				  of practice, include:
1. the number of
				  prescriptions authorized on a daily basis by the practitioner;
2. the manner in which the prescriptions are
				  authorized by the practitioner or received by the pharmacy, i.e.,
				  electronically;
3. the geographical
				  distance between the practitioner and the patient(s);
4. knowledge by the pharmacist that the
				  prescription was issued solely as a result of answers to an electronic
				  questionnaire; or
5. knowledge by
				  the pharmacist that the pharmacy he works for directly or indirectly
				  participates in an internet site that markets prescription drugs to the
				  public.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2517 - Prescription Dispensing; Equivalent Drug Product Interchange; Drug Returns; Drug Disposal

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Prescription dispensing means the issuance, by a licensed pharmacist, of one or
				  more doses of medication in a suitable container, properly labeled for
				  subsequent administration, and shall consist of the following procedures or
				  practices:
1. receiving and interpretation of
				  the prescription order;
2.
				  assembling the drug products and an appropriate container;
3. preparing the prescription by compounding,
				  mixing, counting, or pouring;
4.
				  affixing the proper label to the final container;
5. patient counseling as required;
				  and
6. transfer of
				  possession.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2519 - Prescription Refills; Medication Synchronization and Refill Consolidation

Current through Register Vol. 50, No. 6, June 20, 2024
A. Prescription
				  Refills
1. Limitations on Number of Refills
a. The refilling of a prescription for a drug
				  listed in Schedule II is prohibited.
b. A prescription for a drug listed in
				  Schedule III or IV may be refilled up to five times if so indicated at the time
				  issued.
c. A prescription for a
				  drug listed in Schedule V may be refilled without limitation if so indicated at
				  the time issued subject to the one-year expiration date of the
				  prescription.
d. A prescription for
				  a drug not listed as a controlled substance or for a medical device, medical
				  gas, or durable medical equipment may be refilled without limitation if so
				  indicated at the time issued subject to the one year expiration date of the
				  prescription.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2521 - Emergency Refills

Current through Register Vol. 50, No. 6, June 20, 2024
A. Using sound
				  professional judgment, a pharmacist may refill adequate medication for a
				  quantity not to exceed a 30-day supply when an emergency for medication has
				  been adequately demonstrated and the prescribing practitioner is not available.
				  The 30-day supply limitation shall not apply to multiple-dose unit-of-use
				  containers.
AUTHORITY
					 NOTE: Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2523 - Transfer of Prescription Information

Current through Register Vol. 50, No. 6, June 20, 2024
A. Prescription Transfer Requirements
1. Prescriptions for Controlled Dangerous
				  Substances
a. The transfer of original
				  prescription information for a controlled substance listed in Schedules III,
				  IV, or V for the purpose of refill dispensing is permissible between pharmacies
				  on a one-time basis only. However, pharmacies electronically sharing a
				  real-time, on-line database may transfer up to the maximum refills permitted by
				  law and the prescriber's authorization, whether or not the pharmacy from which
				  the prescription is transferred is open for business. Transfers are subject to
				  the following requirements:
i. The transfer is
				  communicated directly between two licensed pharmacists and the transferring
				  pharmacist records the following information:
(a) invalidation of the
				  prescription;
(b) record on the
				  invalidated prescription the name, address, and DEA registration of the
				  pharmacy to which it was transferred and the name of the pharmacist receiving
				  the prescription information;
(c)
				  record the date of the transfer and the name of the pharmacist transferring the
				  information.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2525 - Prescription Expiration

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				  prescription for a drug other than a controlled dangerous substance listed in
				  Schedules II through IV shall expire one year after the date written.
B. A prescription for a controlled dangerous
				  substance shall expire:
1. 90 days after the
				  date of issue if the drug is listed in schedule II; or
2. six months after the date of issue if the
				  drug is listed in Schedule III or IV.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2527 - Prescription Labeling

Current through Register Vol. 50, No. 6, June 20, 2024
A. An
				  appropriate label shall be affixed to a proper container, and shall bear the
				  following minimum information:
1. pharmacy's
				  name, address, and telephone number;
2. prescription number;
3. authorized prescriber's name;
4. patient's name;
5. date dispensed;
6. drug name and strength;
7. directions for use, as
				  indicated;
8. pharmacist's name or
				  initials; and
9. cautionary
				  auxiliary labels, if applicable.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter B - Prescriptions › Section LIII-2529 - Pharmacy Prepackaging

Current through Register Vol. 50, No. 6, June 20, 2024
A.
Prepackaging
is the preparation of medication in a
				  unit-of-use container by a pharmacist in a pharmacy prior to the receipt of a
				  prescription for ultimate prescription dispensing by a pharmacist in
				  Louisiana.
B. Labeling. The label
				  on the prepackaged container shall contain the following minimum information:
1. drug name;
2. dosage form;
3. strength;
4. quantity;
5. name of manufacturer and/or
				  distributor;
6. manufacturer's lot
				  or batch number;
7. date of
				  preparation;
8. pharmacist's
				  initials; and
9. expiration date
				  according to United States Pharmacopeia (USP) guidelines.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter C - Compounding of Drugs › Section LIII-2531 - Purpose and Scope

Current through Register Vol. 50, No. 6, June 20, 2024
A. Purpose. The
				  rules of this Subchapter describe the requirements of minimum current good
				  compounding practices for the preparation of drug formulations by
				  Louisiana-licensed pharmacists, pharmacy interns, pharmacy technicians, and
				  pharmacy technician candidates for dispensing and/or administration to
				  patients.
B. Scope. These
				  requirements are intended to apply to all compounded preparations, sterile and
				  non-sterile, regardless of the location of the patient, e.g., home, hospital,
				  nursing home, hospice, or practitioners office.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter C - Compounding of Drugs › Section LIII-2533 - Definitions

Current through Register Vol. 50, No. 6, June 20, 2024
A. As used in this
				  Subchapter, the following terms shall have the meaning ascribed to them in this
				  Section.
Biological Safety Cabinet
-a containment
					 unit suitable for the preparation of low to moderate risk agents where there is
					 a need for protection of the product, personnel, and environment, according to
					 National Sanitation Foundation (NSF) Standard 49, or its successor.
Class 100 Environment
-an atmospheric
					 environment that contains fewer than 100 particles, of the size 0.5 microns or
					 less in diameter, per cubic foot of air, according to Federal Standard 209E, or
					 its successor.
Component
-an ingredient used in the
compounding
of a drug product.
Compounding
-the preparation, mixing,
					 assembling, packaging, or labeling of a drug or device by a pharmacist for his
					 patient as the result of a practitioner's prescription drug order or initiative
					 based on the practitioner/patient/pharmacist relationship in the course of
					 professional practice, or including the preparation of drugs or devices in
					 anticipation of prescription orders to be received by the
compounding
pharmacist based on routine, regularly observed
					 prescribing patterns.
Compounding
does not include the
compounding
of drug products that are essentially copies of a
					 commercially available product.
Cytotoxic
-any pharmaceutical that has the
					 capability of killing living cells.
Practitioner Administered
					 Compounds
-products compounded by a licensed pharmacist, upon the
					 medical order of a licensed prescriber for administration by a prescriber for
					 diagnostic or therapeutic purposes.
Preparation
-a compounded drug dosage form
					 or dietary supplement or a device to which a compounder has introduced a drug.
					 This term will be used to describe compounded formulations.
Sterile
					 Compounding
-
compounding
performed using established
					 aseptic technique and utilizing a laminar air flow hood or other device capable
					 of providing a
sterile compounding
environment.
Sterile compounding
shall be used when
compounding
parenteral medications or products, ophthalmic
					 preparations, or any other preparation requiring sterile techniques.
Sterile Product
-any dosage form devoid of
					 viable microorganisms including, but not limited to, parenterals, injectables,
					 and ophthalmics.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter C - Compounding of Drugs › Section LIII-2535 - General Standards

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Compounding Practices. Compounded medications may be prepared using
				  prescription medications, over-the-counter medications, chemicals, compounds,
				  or other components.
1. A pharmacy shall have
				  written procedures as necessary for the compounding of drug preparations to
				  assure that the finished preparations have the identity, strength, quality, and
				  purity they are represented to possess.
2. All compounding shall be accomplished
				  utilizing accepted pharmacy techniques, practices, and equipment, and in
				  compliance with the Federal Food, Drug and Cosmetic Act of 1938 (FDCA) as
				  subsequently amended, the current edition of Title 21 of the Code of Federal
				  Regulations (CFR), and all relevant chapters of the United States
				  Pharmacopeia-National Formulary.
a. The
				  compounding of sterile preparations pursuant to the receipt of a
				  patient-specific prescription shall comply with the provisions of section 503A
				  of the FDCA and USP chapter 797.
b.
				  The compounding of non-sterile preparations pursuant to the receipt of a
				  patient-specific prescription shall comply with the provisions of section 503A
				  of the FDCA and USP chapter 795.
c.
				  The compounding of preparations for veterinary use shall comply with the
				  provisions of section 530 of Title 21 of the CFR.
d. The compounding of positron emission
				  tomography (PET) drugs shall comply with the provisions of section 212 of title
				  21 of the CFR.
3.
				  Products or duplicates of products removed from the market for the purposes of
				  safety shall not be used to compound prescriptions for human use.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 25 - Prescriptions, Drugs, and Devices › Subchapter C - Compounding of Drugs › Section LIII-2537 - Requirements for Compounding Sterile Products (Repealed)

Current through Register Vol. 50, No. 6, June 20, 2024
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 37:1182.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter A - General Provisions › Section LIII-2703 - Controlled Substances

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Classification
1. Controlled substances are
				  specifically identified by reference, as provided in
				  R.S.
				  40:961 et seq., or its successor, and  21 CFR
				  §1308  et seq., or its successor. Schedules I, II, III, IV, and V shall, unless
				  and until added to pursuant to
				  R.S.
				  40:961 et seq., or its successor, consist of
				  the drugs or other substances, by whatever official name, common or usual name,
				  chemical name, or trade name designated, listed in
				  R.S.
				  40:961 et seq., or its successor.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter A - General Provisions › Section LIII-2704 - Added Controlled Dangerous Substances

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  following drugs or substances are added to Schedule I of the Louisiana Uniform
				  Controlled Dangerous Substances Law,
				  R.S.
				  40:961 et seq.:
1. bromazolam.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter B - Licenses › Section LIII-2705 - Licenses and Exemptions

Current through Register Vol. 50, No. 6, June 20, 2024
A. Every
				  person who conducts research with, manufactures, distributes, procures,
				  possesses, prescribes, or dispenses any controlled dangerous substance within
				  this state, including third-party logistics providers, or who proposes to
				  engage in the research, manufacture, distribution, procurement, possession,
				  prescribing, or dispensing of any controlled dangerous substance within this
				  state shall obtain a controlled dangerous substance (CDS) license from the
				  board prior to engaging in such activities. Only persons actually engaged in
				  such activities are required to obtain a CDS license; related or affiliated
				  persons, e.g., stockholder in manufacturing corporation, who are not engaged in
				  such activities, are not required to be licensed. The performance of such
				  activities in the absence of a valid CDS license shall be a violation of
				  R.S.
				  40:973 and this Part.
B. The following persons are exempt from the
				  CDS license requirements of this Chapter:
1.
				  a manufacturer's or distributor's workman, contract carrier, warehouseman or
				  any employee thereof whose handling of controlled substances is in the usual
				  course of his business or employment while on the premises of the employer or
				  under direct transfer orders of the employer;
2. a person who obtains or possesses a
				  controlled substance pursuant to a valid prescription, either for his own use
				  or for the use of a member of his household or for the administration to an
				  animal owned by him or a member of his household;
3. an agent or employee of any licensed
				  manufacturer, distributor, dispenser or researcher in the course of his
				  employment and only on the premises of his employer, but not a sales
				  representative or professional medical representative.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter B - Licenses › Section LIII-2707 - Licensing Procedures

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				  Application for Initial Issuance of CDS License
1. An individual or other entity desiring to
				  obtain a Louisiana CDS license shall complete the application form supplied by
				  the board and submit it with the required attachments and appropriate fees, as
				  set forth in
				  R.S.
				  40:972 and
				  R.S.
				  40:1013, to the board.
2. The applicant shall provide a complete
				  street address reflecting the location where the applicant will engage in the
				  activity for which a Louisiana CDS license is required. The board shall issue
				  only one CDS license for each applicant at each such location.
3. The board shall not process applications
				  received by facsimile, or that are incomplete, or submitted with the incorrect
				  fees.
4. Applicants not in
				  possession of a valid and verifiable license or other credential from a
				  standing professional board of the State of Louisiana, or from the Department
				  of Health, Bureau of Health Services Financing, Health Standards, or their
				  successors, or from the Louisiana Department of Agriculture and Forestry, shall
				  submit to a criminal history record check upon request by the board. The
				  applicant shall pay for the cost of the criminal history record check. The
				  board shall evaluate the findings of the report of the criminal history record
				  check prior to the issuance of the CDS license.
5. An individual or other entity who
				  knowingly or intentionally submits a false or fraudulent application shall be
				  deemed to have committed a prohibited act under
				  R.S.
				  40:961 et seq., or its successor.
6. A CDS license shall be valid for a period
				  of one year, and shall expire annually on the date of initial licensure unless
				  revoked sooner in accordance with the provisions of the Uniform Controlled
				  Dangerous Substances Law or these rules.
7. Practitioners in possession of a temporary
				  or restricted license issued by a standing professional board of competent
				  jurisdiction in the state of Louisiana may be issued a temporary or restricted
				  Louisiana CDS license adhering to the limitations or restrictions of their
				  board license.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter B - Licenses › Section LIII-2709 - Actions on Applications

Current through Register Vol. 50, No. 6, June 20, 2024
A. Upon
				  receipt of a properly completed application and appropriate fees from a
				  qualified applicant, the board shall issue a Louisiana CDS license to the
				  applicant, unless the board intends to deny the application.
B. The board may deny an application for the
				  issuance or renewal of a CDS license for cause. For purposes of this Section,
				  the term "for cause" includes surrender in lieu of, or as a consequence of, any
				  federal or state administrative, civil or criminal action resulting from an
				  investigation of the individual's handling of controlled substances.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter C - Security Requirements › Section LIII-2713 - General Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				  licensee shall provide effective controls and procedures to guard against theft
				  or diversion of controlled substances. In evaluating the overall security
				  system of a licensee or applicant, the board may consider any of the following
				  factors:
1. the type of activity conducted
				  (e.g., processing of bulk chemicals, preparing dosage forms, packaging,
				  labeling, cooperative buying, etc.);
2. the type and form of controlled substances
				  handled (e.g., bulk liquids or dosage units, usable powders or nonusable
				  powders);
3. the quantity of
				  controlled substances handled;
4.
				  the physical location of the premises;
5. the type of building construction
				  comprising the facility and the general characteristics of the
				  building(s);
6. the type of vault,
				  safe, and secure enclosures or other storage system(s) used;
7. the adequacy of key control systems,
				  combination lock control systems, or both;
8. the adequacy of electric detection and
				  alarm systems, if any, including use of supervised transmittal lines and
				  standby power sources;
9. the
				  extent of unsupervised public and visitor access to the facility including
				  maintenance personnel and non-employee service personnel;
10. the adequacy of supervision of employee
				  access;
11. local police protection
				  or security personnel;
12. the
				  adequacy for monitoring the receipt, manufacture, distribution, procurement,
				  and disposition of controlled substances; and
13. the applicability of the security
				  requirements contained in all federal, state, and local laws and regulations
				  governing the management of waste.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter C - Security Requirements › Section LIII-2715 - Physical Security Controls for Non-Practitioners, Narcotic Treatment Programs, and Compounders for Narcotic Treatment Programs

Current through Register Vol. 50, No. 6, June 20, 2024
A. Storage Areas
1. Schedules I and II. Raw materials, bulk
				  materials awaiting further processing, and finished products which are
				  controlled substances listed in Schedule I or II shall be stored in one of the
				  following secure storage areas:
a. Where
				  small quantities permit, a safe or steel cabinet:
i. which safe or steel cabinet shall have the
				  following specifications or the equivalent: 30 man-minutes against
				  surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against
				  lock manipulation, and 20 man-hours against radiological techniques;
ii. which safe or steel cabinet, if it weighs
				  less than 750 pounds, is bolted or cemented to the floor or wall in such a way
				  it cannot be readily removed; and
iii. which safe or steel cabinet, if
				  necessary, depending upon the quantities and type of controlled substances
				  stored, is equipped with an alarm system which, upon attempted unauthorized
				  entry, shall transmit a signal directly to a central protection company or a
				  local or state police agency which has a legal duty to respond, or a 24-hour
				  control station operated by the licensee, or such other protection as the board
				  or its designee may approve;
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter C - Security Requirements › Section LIII-2717 - Physical Security Controls for Practitioners and Pharmacies

Current through Register Vol. 50, No. 6, June 20, 2024
A. Controlled
				  substances listed in Schedule I shall be stored in a securely locked,
				  substantially constructed cabinet.
B. Controlled substances listed in Schedules
				  II, III, IV, and V shall be stored in a securely locked, substantially
				  constructed cabinet. However, pharmacies and institutional practitioners may
				  disperse such substances throughout the stock of non-controlled substances in
				  such a manner as to obstruct the theft or diversion of the controlled
				  substances.
C. This Section shall
				  also apply to non-practitioners authorized to conduct research or chemical
				  analysis under another registration.
D. Carfentanil etorphine hydrochloride and
				  diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S.
				  Government Class V security container.
E. The licensee shall not employ, as an agent
				  or employee who has access to controlled substances, any person who has been
				  convicted of a felony offense relating to controlled substances or who, at any
				  time, had an application for registration with the DEA denied, had a DEA
				  registration revoked or has surrendered a DEA registration for cause. For
				  purposes of this Subsection, the term "for cause" includes surrender in lieu
				  of, or as a consequence of, any federal or state administrative, civil or
				  criminal action resulting from an investigation of the individual's handling of
				  controlled substances.
F. The
				  licensee shall notify the board and the Field Division Office of the DEA in his
				  area, in writing, of the theft or significant loss of any controlled substances
				  within one business day of discovery of such loss or theft. The licensee shall
				  also complete, and submit to the board and the Field Division Office of the DEA
				  in his area, DEA Form 106, or its electronic equivalent, regarding the loss or
				  theft. When determining whether a loss is significant, a licensee should
				  consider, among others, the following factors:
1. the actual quantity of controlled
				  substances lost in relation to the type of business;
2. the specific controlled substances
				  lost;
3. whether the loss of the
				  controlled substances can be associated with access to those controlled
				  substances by specific individuals, or whether the loss can be attributed to
				  unique activities that may take place involving the controlled
				  substances;
4. a pattern of losses
				  over a specific time period, whether the losses appear to be random, and the
				  results of efforts taken to resolve the losses, and, if known;
5. whether the specific controlled substances
				  are likely candidates for diversion;
6. local trends and other indicators of the
				  diversion potential of the missing controlled substance.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter C - Security Requirements › Section LIII-2719 - Security Controls for Freight Forwarding Facilities

Current through Register Vol. 50, No. 6, June 20, 2024
A. All Schedule II-V controlled substances
				  that will be temporarily stored at the freight forwarding facility shall be
				  either:
1. stored in a segregated area under
				  constant observation by designated responsible individual(s); or
2. stored in a secured area that meets the
				  requirements of this Chapter. For purposes of this requirement, a facility that
				  may be locked down (i.e., secured against physical entry in a manner consistent
				  with requirements of this Part) and has a monitored alarm system or is subject
				  to continuous monitoring by security personnel will be deemed to meet the
				  requirements of this Chapter.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter C - Security Requirements › Section LIII-2721 - Employee Screening by Non-Practitioners

Current through Register Vol. 50, No. 6, June 20, 2024
A. An employer's comprehensive employee
				  screening program shall include the following.
1. Question. Within the past five years, have
				  you been convicted of a felony, or within the past two years, of any
				  misdemeanor or are you presently formally charged with committing a criminal
				  offense? (Do not include any traffic violations, juvenile offenses or military
				  convictions, except by general court-martial.) If the answer is yes, furnish
				  details of conviction, offense, location, date and sentence.
2. Question. In the past three years, have
				  you ever knowingly used any narcotics, amphetamines or barbiturates, other than
				  those prescribed to you by a physician or other authorized prescriber? If the
				  answer is yes, furnish details.
3.
				  Advice. An authorization, in writing, that allows inquiries to be made of
				  courts and law enforcement agencies for possible pending charges or convictions
				  shall be executed by a person who is allowed to work in an area where access to
				  controlled substances clearly exists. A person shall be advised that any false
				  information or omission of information will jeopardize his or her position with
				  respect to employment. The application for employment should inform a person
				  that information furnished or recovered as a result of any inquiry will not
				  necessarily preclude employment, but will be considered as part of an overall
				  evaluation of the person's qualifications. The maintaining of fair employment
				  practices, the protection of the person's right of privacy, and the assurance
				  that the results of such inquiries will be treated by the employer in
				  confidence will be explained to the employee.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter D - Labeling and Packaging Requirements › Section LIII-2723 - Symbol Required

Current through Register Vol. 50, No. 6, June 20, 2024
A. Each
				  commercial container of a controlled substance shall have printed on the label
				  the symbol designating the schedule in which such controlled substance is
				  listed. Each such commercial container, if it otherwise has no label, shall
				  bear a label complying with the requirement of this Section.
B. Each manufacturer shall print upon the
				  labeling of each controlled substance distributed by him the symbol designating
				  the schedule in which such controlled substance is listed.
C. The following symbols shall designate the
				  schedule corresponding thereto.
Schedule
Schedule I
CI or C-I
Schedule II
CII or C-II
Schedule III
CIII or C-III
Schedule IV
CIV or C-IV
Schedule V
CV or C-V
1. The word
				  "schedule" need not be used. No distinction need be made between narcotic and
				  non-narcotic substances.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter D - Labeling and Packaging Requirements › Section LIII-2725 - Location and Size of Symbol on Label and Labeling

Current through Register Vol. 50, No. 6, June 20, 2024
A. The symbol shall be prominently located on
				  the label or the labeling of the commercial container and/or the panel of the
				  commercial container normally displayed to dispensers of any controlled
				  substance. The symbol on labels shall be clear and large enough to afford easy
				  identification of the schedule of the controlled substance upon inspection
				  without removal from the dispenser's shelf. The symbol on all other labeling
				  shall be clear and large enough to afford prompt identification of the
				  controlled substance upon inspection of the labeling.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter D - Labeling and Packaging Requirements › Section LIII-2727 - Sealing of Controlled Substances

Current through Register Vol. 50, No. 6, June 20, 2024
A. On each bottle, multiple dose vial, or
				  other commercial container of any controlled substance, there shall be securely
				  affixed to the stopper, cap, lid, covering, or wrapper or such container a seal
				  to disclose upon inspection any tampering or opening of the
				  container.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.
Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part LIII - Pharmacists › Chapter 27 - Controlled Dangerous Substances › Subchapter D - Labeling and Packaging Requirements › Section LIII-2729 - Labeling and Packaging Requirements for Imported and Exported Controlled Substances

Current through Register Vol. 50, No. 6, June 20, 2024
A. The
				  symbol requirements of this Section apply to every commercial container
				  containing, and to all labeling of, controlled substances imported into the
				  jurisdiction of and/or the customs territory of Louisiana.
B. The symbol requirements of this Section do
				  not apply to any commercial containers containing, or any labeling of, a
				  controlled substance intended for export from Louisiana.
C. The sealing requirements of this Section
				  apply to every bottle, multiple dose vial, or other commercial container of any
				  controlled substance listed in schedule I or II, or any narcotic controlled
				  substance listed in schedule III or IV, imported into, exported from, or
				  intended for export from, Louisiana.
AUTHORITY NOTE:
					 Promulgated in accordance with
					 R.S.
					 40:972.