reglab/statecodes huggingface dataset:
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 3. Licensing › 37-7-311. Repealed

37-7-311. Repealed.
Sec. 128, Ch. 429, L. 1995.
History: En. Sec. 644, Pol. C. 1895; re-en. Sec. 1626, Rev. C. 1907; re-en. Sec. 5, Ch. 134, L. 1915; re-en. Sec. 3174, R.C.M. 1921; re-en. Sec. 3174, R.C.M. 1935; amd. Sec. 4, Ch. 175, L. 1939; amd. Sec. 25, Ch. 93, L. 1969; amd. Sec. 3, Ch. 241, L. 1971; amd. Sec. 150, Ch. 350, L. 1974; R.C.M. 1947, 66-1504(2)(g); amd. Sec. 10, Ch. 22, L. 1979; amd. Sec. 4, Ch. 362, L. 1981; amd. Sec. 8, Ch. 379, L. 1981; amd. Sec. 4, Ch. 247, L. 1983.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 3. Licensing › 37-7-321. Certified pharmacy license -- display

37-7-321. Certified pharmacy license -- display.
The board shall provide for the original certification and renewal by the board of every pharmacy doing business in this state. On presentation of evidence satisfactory to the board, on application on a prescribed form, and on the payment of an original certification fee prescribed by the board, the board shall issue a license to a pharmacy as a certified pharmacy. However, the license may be granted only to pharmacies operated by registered pharmacists qualified under this chapter. The license must be displayed in a conspicuous place in the pharmacy for which it is issued. A person may not operate a pharmacy, use the word "pharmacy" to identify the business, or use the word "pharmacy" in advertising unless a license has been issued and is in effect.
History: En. Sec. 8, Ch. 175, L. 1939; amd. Sec. 1, Ch. 76, L. 1959; amd. Sec. 1, Ch. 9, L. 1967; amd. Sec. 1, Ch. 80, L. 1969; amd. Sec. 6, Ch. 241, L. 1971; amd. Sec. 1, Ch. 308, L. 1974; amd. Sec. 154, Ch. 350, L. 1974; amd. Sec. 8, Ch. 533, L. 1977; R.C.M. 1947, 66-1508; amd. Sec. 17, Ch. 345, L. 1981; amd. Sec. 5, Ch. 362, L. 1981; amd. Sec. 9, Ch. 379, L. 1981; amd. Sec. 5, Ch. 247, L. 1983; amd. Sec. 39, Ch. 429, L. 1995; amd. Sec. 11, Ch. 492, L. 1997; amd. Sec. 7, Ch. 388, L. 2001; amd. Sec. 39, Ch. 467, L. 2005.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 3. Licensing › 37-7-322. Use of words pharmacy, apothecary, drug store, or chemist shop for advertising

37-7-322. Use of words pharmacy, apothecary, drug store, or chemist shop for advertising.
It is unlawful for a person to carry on, conduct, or transact a retail business under a name which contains as a part of the business the words "pharmacy", "apothecary", "drug store", or "chemist shop" or any abbreviation, translation, extension, or variation of those terms or in any manner by advertisement circular or poster, sign, or otherwise to describe or refer to the place of business conducted by that person by the term, abbreviation, translation, extension, or variation unless the business conducted is a pharmacy within the meaning of this chapter and licensed and in the charge of a licensed pharmacist.
History: En. Sec. 11, Ch. 175, L. 1939; amd. Sec. 9, Ch. 101, L. 1977; R.C.M. 1947, 66-1522; amd. Sec. 8, Ch. 388, L. 2001.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 3. Licensing › 37-7-323. Repealed

37-7-323. Repealed.
Sec. 10, Ch. 366, L. 2023.
History: En. Sec. 5, Ch. 104, L. 1931; re-en. Sec. 3202.11, R.C.M. 1935; amd. Sec. 15, Ch. 175, L. 1939; R.C.M. 1947, 66-1526; amd. Sec. 6, Ch. 219, L. 1991; amd. Sec. 9, Ch. 388, L. 2001.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 3. Licensing › 37-7-324. Deposit of fees and fines

37-7-324. Deposit of fees and fines.
Fines paid under this chapter, except those paid to a justice's court, and fees collected by the department for registration and licenses issued under this chapter shall be deposited in the state special revenue fund for the use of the board, subject to 37-1-101(6).
History: En. Sec. 6, Ch. 104, L. 1931; re-en. Sec. 3202.12, R.C.M. 1935; amd. Sec. 16, Ch. 175, L. 1939; amd. Sec. 134, Ch. 147, L. 1963; amd. Sec. 159, Ch. 350, L. 1974; R.C.M. 1947, 66-1527; amd. Sec. 1, Ch. 277, L. 1983; amd. Sec. 23, Ch. 557, L. 1987.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-401. Restrictions on prescriptions

37-7-401. Restrictions on prescriptions.
(1) An authorized prescriber may not sell, give to, or prescribe for any person any opium, morphine, alkaloid-cocaine, alpha or beta eucaine, codeine, heroin, or any derivative, mixture, or preparation of any of them, except to a patient believed in good faith to require opium, morphine, alkaloid-cocaine, alpha or beta eucaine, codeine, heroin, or any derivative, mixture, or preparation of the enumerated substances for medical use and in quantities proportioned to the needs of the patient.
(2) A prescription must be written so that the prescription can be compounded by any registered pharmacist. The coding of any prescription is a violation of this section.
(3) A prescription marked "non repetatur", "non rep", or "N.R." cannot be refilled. A prescription marked to be refilled may be filled by any registered pharmacist the number of times marked on the prescription. A prescription not bearing any refill instructions may not be refilled without first obtaining permission from the prescriber. A prescription may not be refilled for more than 1 year from the date the prescription was originally written. A Schedule II prescription may not be refilled.
History: En. Sec. 2, Ch. 11, L. 1911; re-en. Sec. 3187, R.C.M. 1921; re-en. Sec. 3187, R.C.M. 1935; amd. Sec. 2, Ch. 33, L. 1951; R.C.M. 1947, 66-1514; amd. Sec. 10, Ch. 379, L. 1981; amd. Sec. 17, Ch. 97, L. 1989; amd. Sec. 2, Ch. 444, L. 1989; amd. Sec. 10, Ch. 388, L. 2001; amd. Sec. 27, Ch. 126, L. 2005.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-402. Penalty for violation of provisions on sale or prescription of opiates, coding, refilling

37-7-402. Penalty for violation of provisions on sale or prescription of opiates, coding, refilling.
Any person found guilty of the violation of 37-7-401 shall be punished for each separate offense (and each and every individual case shall constitute a separate offense) by a fine of not less than $50 or more than $500 or by imprisonment in the county jail for a period of not less than 60 days or more than 100 days or by both such fine and imprisonment.
History: En. Sec. 3, Ch. 11, L. 1911; re-en. Sec. 3188, R.C.M. 1921; re-en. Sec. 3188, R.C.M. 1935; R.C.M. 1947, 66-1515.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-403. Repealed

37-7-403. Repealed.
Sec. 8, Ch. 247, L. 1983.
History: En. Sec. 1, Ch. 11, L. 1935; re-en. Sec. 3185.1, R.C.M. 1935; amd. Sec. 155, Ch. 350, L. 1974; R.C.M. 1947, 66-1511.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-404. Repealed

37-7-404. Repealed.
Sec. 8, Ch. 247, L. 1983.
History: En. Sec. 2, Ch. 11, L. 1935; re-en. Sec. 3185.2, R.C.M. 1935; amd. Sec. 156, Ch. 350, L. 1974; R.C.M. 1947, 66-1512.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-405. Repealed

37-7-405. Repealed.
Sec. 8, Ch. 247, L. 1983.
History: En. Sec. 3, Ch. 11, L. 1935; re-en. Sec. 3185.3. R.C.M. 1935; R.C.M. 1947, 66-1513.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-406. Standards for prospective drug utilization review and patient counseling

37-7-406. Standards for prospective drug utilization review and patient counseling.
(1) The board may by rule set standards for the provision of prospective drug utilization review information from a pharmacist to a patient before a prescription is dispensed to the patient or the patient's representative. The review may include, when applicable, an appropriate level of screening for potential drug therapy problems due to therapeutic duplication, drug disease contraindications, drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.
(2) Under the standards provided for in this section, the pharmacist should offer to discuss those matters that, in the pharmacist's professional judgment, the pharmacist considers significant to the patient's safe and proper use of the prescribed drug. The patient counseling should encompass the topics set forth in 42 U.S.C. 1396r-8 of the Social Security Act and administrative rules established by the board.
(3) Communications between a pharmacist and a patient pursuant to the standards provided for in this section constitute health care information for the purposes of Title 50, chapter 16, part 5.
(4) Standards established by the board under this section apply to all patients seen by a pharmacist or to categories of patients as the board may designate. However, standards provided for in this section may not apply to inpatients of a health care facility in which a nurse or other licensed health care professional is authorized to administer the prescribed drug.
History: En. Sec. 1, Ch. 664, L. 1991; amd. Sec. 11, Ch. 388, L. 2001.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-407. Repealed

37-7-407. Repealed.
Sec. 10, Ch. 366, L. 2023.
History: En. Sec. 8, Ch. 664, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 4. Prescriptions Regulated -- Review -- Counseling -- Identification › 37-7-410. Positive identification required

37-7-410. Positive identification required.
(1) (a) Except as provided in subsection (2), a pharmacy may not dispense a controlled substance to a potential recipient without first positively identifying the recipient by means of a valid driver's license, a school district or postsecondary education photo identification, a tribal photo identification, or other identification allowed by the board by rule.
(b) Documentation of the recipient's identification must be permanently linked to the record of the dispensed controlled substance and must include:
(i) a copy of the identification presented; or
(ii) a record that includes:
(A) the recipient's name;
(B) the type of identification presented and the unique identification number; and
(C) the government entity that issued the identification.
(2) Positive identification is not required if:
(a) the controlled substance is dispensed directly to the patient and:
(i) the filled prescription is delivered to the patient or the patient's health care provider; or
(ii) the patient is being treated at a health care facility or is housed in a correctional facility; or
(b) the potential recipient of the controlled substance is personally and positively known by a pharmacist or an employee of the pharmacy who is present and identifies the recipient and the personal identification is documented by recording:
(i) the recipient's name;
(ii) a notation indicating that the recipient was known to a pharmacist or an employee of the pharmacy; and
(iii) the identity of the individual making the personal identification.
History: En. Sec. 1, Ch. 89, L. 2019.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-501. Short title

37-7-501. Short title.
This part may be cited as the "Montana Drug Product Selection Act".
History: En. 66-1528 by Sec. 1, Ch. 403, L. 1977; R.C.M. 1947, 66-1528.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-502. Definitions

37-7-502. Definitions.
As used in this part, the following definitions apply:
(1) "Bioavailability" means the extent and rate of absorption from a dosage form as reflected by the time-concentration curve of the administered drug in the systemic circulation.
(2) "Bioequivalent" means a chemical equivalent that, when administered to the same individual in the same dosage regimen, will result in comparable bioavailability.
(3) "Biological product" has the meaning provided in 42 U.S.C. 262.
(4) "Brand name" means the proprietary or the registered trademark name given to a drug product by its manufacturer, labeler, or distributor and placed upon the drug, its container, label, or wrapping at the time of packaging.
(5) "Chemical equivalent" means drug products that contain the same amounts of the same therapeutically active ingredients in the same dosage forms and that meet present compendium standards.
(6) "Drug product" means a dosage form containing one or more active therapeutic ingredients along with other substances included during the manufacturing process.
(7) "Generic name" means the chemical or established name of a drug product or drug ingredient published in the latest edition of an official compendium recognized by the board.
(8) "Interchangeable biological product" means a biological product that the federal food and drug administration has:
(a) licensed; and
(b) (i) determined meets the standards for interchangeability pursuant to 42 U.S.C. 262(k)(4); or
(ii) determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal food and drug administration's approved drug products with therapeutic equivalence evaluations.
(9) "Person" has the meaning provided in 37-7-101.
(10) "Prescriber" means a medical practitioner, as defined in 37-2-101, licensed under the professional laws of the state to administer and prescribe medicine and drugs.
(11) "Present compendium standard" means the official standard for drug excipients and drug products listed in the latest revision of an official compendium recognized by the board.
(12) "Product selection" means to dispense without the prescriber's express authorization a different drug product in place of the drug product prescribed.
(13) "Therapeutically equivalent" means those chemical equivalents that, when administered in the same dosage regimen, will provide essentially the same therapeutic effect as measured by the control of a symptom or a disease and/or toxicity.
History: En. 66-1529 by Sec. 2, Ch. 403, L. 1977; R.C.M. 1947, 66-1529; amd. Sec. 11, Ch. 379, L. 1981; amd. Sec. 12, Ch. 388, L. 2001; amd. Sec. 1, Ch. 42, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-503. Rulemaking

37-7-503. Rulemaking.
The board of pharmacy may adopt, amend, or repeal rules necessary for the implementation, continuation, and enforcement of this part in accordance with the Montana Administrative Procedure Act.
History: En. 66-1535 by Sec. 8, Ch. 403, L. 1977; R.C.M. 1947, 66-1535; amd. Sec. 1, Ch. 247, L. 1983.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-504. General prohibition of drug product substitution

37-7-504. General prohibition of drug product substitution.
No person may substitute a drug product different from the one ordered or deviate in any manner from the requirements of an order or prescription, except as provided in this part.
History: En. 66-1523(2) by Sec. 10, Ch. 403, L. 1977; R.C.M. 1947, 66-1523; amd. Sec. 2, Ch. 42, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-505. Product selection permitted -- limitation

37-7-505. Product selection permitted -- limitation.
(1) Except as limited by subsection (2) and unless instructed otherwise by the purchaser:
(a) a pharmacist who receives a prescription for a specific drug product by brand or proprietary name may select a less expensive drug product with the same generic name, strength, quantity, dose, and dosage form as the prescribed drug that is, in the pharmacist's professional opinion, therapeutically equivalent, bioequivalent, and bioavailable; and
(b) a pharmacist who receives a prescription for a specific biological product may select a less expensive interchangeable biological product.
(2) If, in the professional opinion of the prescriber, it is medically necessary that an equivalent drug product or interchangeable biological product not be selected, the prescriber may so indicate by certifying that the specific brand-name drug product prescribed or the specific brand-name biological product prescribed is medically necessary for that particular patient. In the case of a prescription transmitted orally, the prescriber must expressly indicate to the pharmacist that the specific brand-name drug product prescribed or the specific biological product prescribed is medically necessary.
(3) (a) Within 5 business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate the specific product provided to the patient, including the name of the product and the manufacturer, to the prescriber through any of the following electric records systems:
(i) an interoperable electronic medical records system;
(ii) an electronic prescribing technology;
(iii) a pharmacy benefit management system; or
(iv) a pharmacy record.
(b) Communication through an electronic records system as described in subsection (3)(a) is presumed to provide notice to the prescriber.
(c) If the pharmacist is unable to communicate pursuant to an electronic records system as provided in subsection (3)(a), the pharmacist shall communicate to the prescriber which biological product was dispensed to the patient using facsimile, telephone, electronic transmission, or other prevailing means.
(d) Communication is not required under this subsection (3) when:
(i) there is no federal food and drug administration approved interchangeable biological product for the product prescribed; or
(ii) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
(4) The pharmacist shall maintain a record of the biological product dispensed for at least 2 years.
History: En. 66-1530 by Sec. 3, Ch. 403, L. 1977; R.C.M. 1947, 66-1530; amd. Sec. 13, Ch. 388, L. 2001; amd. Sec. 3, Ch. 42, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-506. Notice to purchaser

37-7-506. Notice to purchaser.
(1) A pharmacist who selects a drug product, as provided in 37-7-505, shall notify the person presenting the prescription that the person may refuse the product selection as provided in 37-7-505.
(2) Each pharmacy shall display in a prominent place that is in clear and unobstructed public view, at or near the place where prescriptions are dispensed, a sign stating: "This pharmacy may be able to select a less expensive drug product that is equivalent to the one prescribed by your physician unless you or your physician request otherwise." The printing on the sign must be in block letters not less than 1 inch in height.
History: En. 66-1531 by Sec. 4, Ch. 403, L. 1977; R.C.M. 1947, 66-1531; amd. Sec. 1368, Ch. 56, L. 2009.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-507. Savings passed on

37-7-507. Savings passed on.
(1) A pharmacist selecting a less expensive drug product must pass on to the purchaser the full amount of the savings realized by the product selection. In no event may the pharmacist charge a different professional fee for dispensing a different drug product than the drug product originally prescribed.
(2) If the prescriber prescribes a drug product by its generic name, the pharmacist must, consistent with reasonable judgment, dispense the lowest retail priced, therapeutically equivalent brand which is in stock.
History: En. 66-1532 by Sec. 5, Ch. 403, L. 1977; R.C.M. 1947, 66-1532.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-508. Product selection not practice of medicine

37-7-508. Product selection not practice of medicine.
The selection of a drug product by a registered pharmacist under the provisions of this part does not constitute the practice of medicine.
History: En. 66-1533 by Sec. 6, Ch. 403, L. 1977; R.C.M. 1947, 66-1533.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-509. Limitations on liability

37-7-509. Limitations on liability.
(1) A pharmacist making a product selection under the provisions of this part assumes no greater responsibility for selecting the dispensed drug product than the pharmacist would incur in filling a prescription for a drug product prescribed by a generic name.
(2) When a pharmacist selects a drug product, the prescriber may not be held liable in an action for loss, damage, injury, or death to a person caused by the use of the selected drug product, except that if the original drug product was incorrectly prescribed, the prescriber is not relieved of liability.
History: En. 66-1534 by Sec. 7, Ch. 403, L. 1977; R.C.M. 1947, 66-1534; amd. Sec. 1369, Ch. 56, L. 2009.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 5. Drug Product Selection › 37-7-510. Repealed

37-7-510. Repealed.
Sec. 10, Ch. 366, L. 2023.
History: En. 66-1536 by Sec. 11, Ch. 403, L. 1977; R.C.M. 1947, 66-1536; amd. Sec. 1, Ch. 247, L. 1983.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-601. Scope and purpose

37-7-601. Scope and purpose.
This part applies to the wholesale distribution, third-party logistics, manufacturing, or repackaging of prescription drugs in this state. The purpose of this part is to implement the federal Prescription Drug Marketing Act of 1987 and the Drug Quality and Security Act of 2013, which includes but is not limited to the Drug Supply Chain Security Act, by providing minimum standards, terms, and conditions for licensing by the department of persons or entities engaged in the wholesale distribution, third-party logistics, manufacturing, or repackaging of prescription drugs.
History: En. Sec. 2, Ch. 134, L. 1991; amd. Sec. 3, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-602. Definitions

37-7-602. Definitions.
As used in this part, the following definitions apply:
(1) (a) "Dispenser" means a retail pharmacy, a hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of the entities listed in this subsection (1)(a), if they are under common ownership and control and do not act as a wholesale distributor.
(b) The term does not include a person who dispenses only products used in animals in accordance with FDA laws and regulations.
(2) "Manufacturer" means:
(a) a person approved by application to the FDA to manufacture a product as defined in section 360eee of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq., or a biologic pursuant to 42 U.S.C. 262;
(b) a person who manufactures a product as defined in section 360eee of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq., or a biologic pursuant to 42 U.S.C. 262 that is not the subject of an approved application or license by the FDA;
(c) a colicensed partner of a person described in subsection (2)(a) or (2)(b) that obtains the product directly from a person described in subsection (2)(a), (2)(b), or (2)(d); or
(d) an affiliate of a person described in subsection (2)(a), (2)(b), or (2)(c) that receives the product directly from a person described in subsection (2)(a), (2)(b), or (2)(c).
(3) "Prescription drug" has the same meaning as provided in 37-7-101.
(4) "Repackager" means a person who owns or operates an establishment that repacks and relabels a product or a package for:
(a) further sale; or
(b) distribution without a further transaction.
(5) "Third-party logistics provider" or "3PL" means an entity that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product but does not take ownership of the product or have responsibility to direct the sale or disposition of the product.
(6) "Transaction" has the same meaning as provided in section 360eee of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq.
(7) (a) "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient.
(b) The term does not include the exclusions listed in section 353(e)(4) of the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq.
(8) "Wholesale distributor" means a person or entity, other than a manufacturer, a manufacturer's colicensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution of prescription drugs.
History: En. Sec. 3, Ch. 134, L. 1991; amd. Sec. 14, Ch. 388, L. 2001; amd. Sec. 73, Ch. 114, L. 2003; amd. Sec. 4, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-603. Prohibited purchase or receipt of drugs -- dispensing and distribution restrictions -- penalty

37-7-603. Prohibited purchase or receipt of drugs -- dispensing and distribution restrictions -- penalty.
(1) Except as otherwise provided, it is unlawful for a person to knowingly purchase or receive a prescription drug from a source other than a person or entity licensed under this part.
(2) Licensed wholesale distributors, third-party logistics providers, manufacturers, and repackagers may not dispense or distribute prescription drugs directly to patients, except when the licensed wholesale distributor is also a licensed pharmacy.
(3) A person who violates the provisions of this section is guilty of a misdemeanor.
History: En. Sec. 4, Ch. 134, L. 1991; amd. Sec. 5, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-605. Out-of-state licensing requirements

37-7-605. Out-of-state licensing requirements.
(1) An out-of-state wholesale distributor, third-party logistics provider, manufacturer, or repackager may not conduct business in this state without first obtaining a license from the board and paying the license fee established by the board.
(2) Application for a license under this section must be made on an approved form.
(3) The issuance of a license may not affect tax liability imposed by the department of revenue on any out-of-state licensee.
(4) A person acting as principal or agent for an out-of-state licensee may not sell or distribute prescription drugs in this state unless the wholesale distributor, third-party logistics provider, manufacturer, or repackager has obtained a license.
History: En. Sec. 6, Ch. 134, L. 1991; amd. Sec. 40, Ch. 467, L. 2005; amd. Sec. 7, Ch. 33, L. 2017; amd. Sec. 23, Ch. 3, L. 2019.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-606. Licenses

37-7-606. Licenses.
A license for a wholesale distributor, third-party logistics provider, manufacturer, or repackager is effective during the period specified by department rule.
History: En. Sec. 7, Ch. 134, L. 1991; amd. Sec. 40, Ch. 429, L. 1995; amd. Sec. 12, Ch. 492, L. 1997; amd. Sec. 41, Ch. 467, L. 2005; amd. Sec. 8, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-607. Repealed

37-7-607. Repealed.
Sec. 128, Ch. 429, L. 1995.
History: En. Sec. 8, Ch. 134, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-608. Repealed

37-7-608. Repealed.
Sec. 128, Ch. 429, L. 1995.
History: En. Sec. 9, Ch. 134, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-609. Board access to records

37-7-609. Board access to records.
Wholesale distributors, third-party logistics providers, manufacturers, and repackagers may keep records at a central location apart from the principal office of the wholesale distributor , third-party logistics provider, manufacturer, and repackager or the location where the drugs are stored and from where they are shipped, if the records are available for inspection within 2 working days of a request by the board. The records may be kept in any form permissible under federal law applicable to prescription drug recordkeeping.
History: En. Sec. 10, Ch. 134, L. 1991; amd. Sec. 9, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-610. Rulemaking authority

37-7-610. Rulemaking authority.
(1) The board shall adopt rules and regulations necessary to carry out the purpose and enforce the provisions of this part, including FDA guidelines and rules pursuant to the Drug Quality and Security Act of 2013, which includes the Drug Supply Chain Security Act, 21 U.S.C. 301, et seq., to implement:
(a) product tracing, reporting, and other requirements compliant with FDA uniform national policy; or
(b) national standards for the licensing of wholesale distributors, third-party logistics providers, manufacturers, and repackagers.
(2) If the rules and regulations conflict with the wholesale distributor, third-party logistics provider, manufacturer, or repackager guidelines or rules promulgated by the FDA, the latter control.
History: En. Sec. 11, Ch. 134, L. 1991; amd. Sec. 10, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-611. Criminal background check for wholesale distributors and third-party logistics providers

37-7-611. Criminal background check for wholesale distributors and third-party logistics providers.
(1) Each applicant for licensure as a wholesale distributor or a third-party logistics provider shall submit a full set of the applicant's fingerprints to the board for the purpose of obtaining a state and federal criminal history background check.
(2) Each license applicant is responsible to pay all fees charged in relation to obtaining the state and federal criminal history background check.
(3) The board may require a licensee renewing a license to submit a full set of the licensee's fingerprints to the board for the purpose of obtaining a state and federal criminal history background check.
(4) The Montana department of justice may share the fingerprint data obtained under subsection (1) or (3) with the federal bureau of investigation.
History: En. Sec. 11, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 6. Wholesale Distributors -- Licensing › 37-7-612. Bond requirements for wholesale distributors

37-7-612. Bond requirements for wholesale distributors.
An applicant for licensure as a wholesale distributor and all wholesale distributors renewing licenses shall comply with the surety bond requirements as provided in rule.
History: En. Sec. 12, Ch. 33, L. 2017.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-701. Legislative declaration

37-7-701. Legislative declaration.
The legislature recognizes that with the proliferation of alternate methods of health care delivery, there has arisen among third-party payors and insurance companies the desire to control the cost and use of pharmacy services through a variety of mechanisms, including the use of mail service pharmacies located outside this state. As a result, the legislature finds and declares that to continue to protect the consumer-patients of this state, all out-of-state mail service pharmacies that provide services to this state's residents must be registered with the board, shall disclose specific information about their services, shall meet the same standards for utilization of technicians as an in-state pharmacy, and shall provide pharmacy services at a high level of competence.
History: En. Sec. 2, Ch. 664, L. 1991; amd. Sec. 2, Ch. 300, L. 1993; amd. Sec. 2, Ch. 274, L. 1995.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-702. Out-of-state mail service pharmacy defined

37-7-702. Out-of-state mail service pharmacy defined.
"Out-of-state mail service pharmacy" means a pharmacy located outside this state that:
(1) ships, mails, or delivers by any lawful means a dispensed legend drug to a resident in this state pursuant to a legally issued prescription;
(2) provides to a resident of this state information on drugs or devices that may include but is not limited to advice relating to therapeutic values, potential hazards, and uses; or
(3) counsels pharmacy patients residing in this state concerning adverse and therapeutic effects of drugs.
History: En. Sec. 3, Ch. 664, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-703. Registration requirements

37-7-703. Registration requirements.
Each out-of-state mail service pharmacy must be registered with the board of pharmacy. In order to be registered with the board to do business in this state and for the renewal of its registration, an out-of-state mail service pharmacy:
(1) (a) shall submit a certificate from the appropriate licensing authority with which it is currently licensed and in good standing in the state in which its dispensing facilities are located; and
(b) shall comply with all applicable laws, regulations, and standards of that state and the United States and, if requested by the board, provide evidence that it has complied;
(2) shall register with the board and provide information on ownership and location, including the names and titles of the corporate officers, of the out-of-state mail service pharmacy and the identity of a pharmacist licensed in the state in which the pharmacy is located who is in charge of dispensing prescriptions for shipment to Montana from the out-of-state mail service pharmacy;
(3) shall submit a utilization plan for the employment of pharmacy technicians if allowed by the state where the mail service pharmacy is located. If the state in which the pharmacy is located does not establish a ratio of technicians to pharmacists for determining the number of pharmacy technicians or otherwise define the role of the pharmacist in compounding or dispensing drugs at the pharmacy, then the out-of-state mail service pharmacy may not allow a pharmacist to supervise more than one supportive person at any one time in the compounding or dispensing of prescription drugs, unless approved by the board as provided in 37-7-307 through 37-7-309.
(4) shall submit to the board proof of the pharmacist's good standing with the licensing authority in the state where the pharmacist is employed and the pharmacist's written commitment to comply with the utilization plan, if any, for each pharmacist identified under subsection (2) and shall provide to the board the same toll-free telephone service referenced in 37-7-706 in order to comply with all information requests by the board; and
(5) shall pay an initial registration fee and a periodic renewal fee in an amount to be determined by the board and at a time established by the department by rule.
History: En. Sec. 4, Ch. 664, L. 1991; amd. Sec. 3, Ch. 300, L. 1993; amd. Sec. 3, Ch. 274, L. 1995; amd. Sec. 13, Ch. 492, L. 1997.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-704. Inspections

37-7-704. Inspections.
If the licensing or regulatory agency of the state in which an out-of-state mail service pharmacy is domiciled fails or refuses to inspect the out-of-state mail service pharmacy after receiving a request for an inspection from the board of this state, the board may cancel the out-of-state pharmacy's right to do business in this state unless the out-of-state pharmacy agrees to an onsite inspection by the board of this state.
History: En. Sec. 5, Ch. 664, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-705. Product selection of prescribed drugs -- notification

37-7-705. Product selection of prescribed drugs -- notification.
(1) An out-of-state mail service pharmacy may not substitute a prescription drug unless the substitution is made in compliance with the laws of this state and the rules and regulations of the board.
(2) An out-of-state mail service pharmacy may not dispense a substitute drug product to a resident of this state without notifying the patient of the substitution either by telephone or in writing.
History: En. Sec. 6, Ch. 664, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-706. Patient communication -- telephone service

37-7-706. Patient communication -- telephone service.
Every out-of-state mail service pharmacy shall provide a toll-free telephone service, available at least 6 days a week and for 40 hours a week, to facilitate communication as may be required under this part, between patients in this state and a pharmacist who has access to the patients' records at the out-of-state mail service pharmacy. The toll-free telephone number must be affixed to all drug product containers dispensed to patients in this state.
History: En. Sec. 7, Ch. 664, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-710. Repealed

37-7-710. Repealed.
Sec. 128, Ch. 429, L. 1995.
History: En. Sec. 4, Ch. 300, L. 1993.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-711. Repealed

37-7-711. Repealed.
Sec. 10, Ch. 366, L. 2023.
History: En. Sec. 8, Ch. 664, L. 1991.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 7. Out-of-State Mail Service Pharmacies › 37-7-712. Rulemaking authority

37-7-712. Rulemaking authority.
The board of pharmacy may adopt rules to implement this part.
History: En. Sec. 4, Ch. 274, L. 1995.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 11. Peer Review › 37-7-1101. Nonliability for peer review

37-7-1101. Nonliability for peer review.
No member, employee, or volunteer intervenor of the Montana pharmaceutical association in its peer review program is liable in damages to any person for any action taken or recommendation made within the scope of the program if the member, employee, or volunteer acts in good faith in accordance with the rules of the association.
History: En. Sec. 1, Ch. 235, L. 1987.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 14. Donated Drugs and Devices Program › 37-7-1401. Programs for donation of unused prescription drugs, cancer drugs, and devices -- rulemaking required

37-7-1401. Programs for donation of unused prescription drugs, cancer drugs, and devices -- rulemaking required.
(1) The board of pharmacy shall, in consultation and cooperation with the department of public health and human services, create a program for the donation of prescription drugs collected from long-term care facilities to qualified patients.
(2) For the purposes of the program created pursuant to subsection (1), prescription drugs, except those drugs defined as a dangerous drug in 50-32-101 or a drug designated as a precursor to a controlled substance in 50-32-401, unneeded by a resident or former resident of a long-term care facility may be donated by the long-term care facility to a provisional community pharmacy that provides or may provide prescription drugs to individuals who are qualified patients for transfer free of charge or at a reduced charge to those individuals.
(3) This section does not amend or otherwise change the law applicable to the prescribing of prescription drugs, the sale of those drugs, or the licensing of long-term care facilities or pharmacies.
(4) The board of pharmacy shall adopt rules to implement this part. The rules must address:
(a) the collection, receipt, and storage of donated drugs and devices;
(b) the transfer of prescription drugs donated by a long-term care facility to provisional community pharmacies;
(c) which pharmacies may be considered provisional community pharmacies that may sell or give the prescription drugs donated by long-term care facilities to others;
(d) eligibility criteria and other standards and procedures for participants that accept and distribute or dispense donated cancer drugs or devices;
(e) the forms needed for the administration of the donated drug programs;
(f) categories of cancer drugs and devices that the cancer drug repository program will accept for dispensing and categories it will not accept, including the reason that a cancer drug or device will not be accepted;
(g) the price for which the prescription drugs donated by a long-term care facility may be sold; and
(h) the maximum handling fee that may be charged by participants that accept and distribute or dispense a cancer drug or device.
(5) In adopting the rules, the board of pharmacy shall consider the ability of persons to pay for the drugs and the existence and operation of similar programs in other states.
History: En. Sec. 1, Ch. 362, L. 2001; amd. Sec. 5, Ch. 299, L. 2009.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 14. Donated Drugs and Devices Program › 37-7-1402. Identifying information to be deleted from donated drugs or devices

37-7-1402. Identifying information to be deleted from donated drugs or devices.
A person or entity donating a prescription drug, a cancer drug, or a device pursuant to the programs created under this part shall delete from the container in which the drug or device is held any information by which the person for whom the drug or device was prescribed may be identified.
History: En. Sec. 2, Ch. 362, L. 2001; amd. Sec. 6, Ch. 299, L. 2009.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 14. Donated Drugs and Devices Program › 37-7-1403. Cancer drug repository program -- donations -- registry

37-7-1403. Cancer drug repository program -- donations -- registry.
(1) The board shall establish a cancer drug repository program for accepting donated cancer drugs and devices and dispensing the drugs and devices to qualified patients. Participation in the program is voluntary.
(2) Any person or entity, including but not limited to a health care facility or the manufacturer of a cancer drug or device, may donate cancer drugs or devices to a participant pursuant to the provisions of 37-7-1403 through 37-7-1405.
(3) The board shall establish and maintain a registry of participants in the cancer drug repository program. The participant registry must:
(a) include the participant's name, address, and telephone number; and
(b) identify whether the participant is a physician's office, pharmacy, hospital, or health clinic.
(4) The board shall make the participant registry available to a person or entity wishing to donate a cancer drug or device to the cancer drug repository program.
History: En. Sec. 1, Ch. 299, L. 2009.
2023 Montana Code Annotated › Title 37. Professions and Occupations › Chapter 7. Pharmacy › Part 14. Donated Drugs and Devices Program › 37-7-1404. Cancer drugs or devices accepted or dispensed -- conditions

37-7-1404. Cancer drugs or devices accepted or dispensed -- conditions.
(1) (a) Unless otherwise prohibited by law, a cancer drug or device may be accepted or dispensed under the cancer drug repository program established under 37-7-1403 if the drug or device is in its original, unopened, sealed, and tamper-evident unit dose packaging.
(b) A cancer drug packaged in single-unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit dose packaging is unopened.
(2) A cancer drug may not be accepted or dispensed under this section if the drug:
(a) bears an expiration date that is earlier than 6 months after the date the drug was donated;
(b) is considered adulterated or misbranded under the provisions of Title 50, chapter 31, part 3; or
(c) is subject to restricted distribution pursuant to 21 CFR 314.520.
(3) Subject to the limitations provided in this section, an unused cancer drug or device dispensed under the medicaid program provided for in Title 53, chapter 6, may be accepted and dispensed under the cancer drug repository program.
(4) A cancer drug or device donated under this program must be stored:
(a) separately from other prescription drugs or stock;
(b) according to the manufacturer's recommended storage conditions; and
(c) in the compounding or dispensing area if stored in a pharmacy.
(5) In dispensing a donated cancer drug or device, a participant shall give first priority to a qualified patient in the participant's service area. Other cancer patients may receive donated cancer drugs or devices if a qualified patient is not available.
(6) A participant shall notify a patient if the patient is receiving a cancer drug or device that has been donated.
History: En. Sec. 2, Ch. 299, L. 2009.