Filename: 2475.html
Match Number: 4 of 70
Score: 39
ENTRY_DATE: 030302
APPELLANT: Cathy Kirkpatrick Oklahoma State Board of Veterinary Medical Examiners
JURISDICTION: Attorney General of Oklahoma - Opinion
HEARING_DATE: February 14, 2002
TEXT_OF_RULE:
Dear Ms. Kirkpatrick:
This office has received your request for an official Attorney General Opinion in which you ask, in effect, the following question:
May a "wholesaler" or "distributor" of veterinary prescription drugs, dispense a veterinary prescription drug directly to a veterinarian's client if the veterinary prescription drug. has never been "certified" by a pharmacist or other licensed practitioner?
This question arose because of recent legislation which allows a "wholesaler" or "distributor" of veterinary prescription drugs to dispense such drugs directly to a veterinarian's client.1 Stated more generally, the question is whether any employee of a "wholesaler" or "distributor" may fill and dispense a veterinary prescription drug - even if that employee is not a registered pharmacist. The answer is no.
Senate Bill 466 amended 59 O.S. 353.13 (2000) as follows:
"A. It shall be unlawful for~any person, other than a registered pharmacist or assistant pharmacist, to certify the finished prescription, as defined by the Board, before delivery ,to, the patient or the patient's agent or care giver.
"B. It shall be unlawful for any person to institute or manage a pharmacy unless such person shall be a registered pharmacist, or shall place in charge of said pharmacy are registered pharmacist.
"C. No registered pharmacist shall manage, supervise nor be in charge of more than one pharmacy.
"D. No pharmacist being requested to sell, furnish or compound any drug, medicine, chemical or other pharmaceutical preparation, by prescription or otherwise, shall substitute or cause to be substituted therefor, without authority of the prescriber or purchaser, any like drug, medicine, chemical or pharmaceutical preparation.
"E. No proprietor of a pharmacy, or other person, shall permit the practice of pharmacy except by a registered pharmacist or assistant pharmacist.
"F. No proprietor of a pharmacy, or other person, shall subvert the authority of the pharmacist in charge of the pharmacy by impeding the management of the prescription department in compliance with federal and state pharmacy laws and regulations.
"G. Nothing in the Oklahoma Pharmacy Act shall prevent veterinary prescription drugs from being shipped directly from a wholesaler or distributor to a client; provided, such drugs may be dispensed only on prescription of a licensed veterinarian and only when an existing veterinary-client-patient relationship exists."
2001 Okla. Sess. Laws ch. 400, sec 7.
Senate Bill 466 also amended 59 O.S. 353.24 (4) (2000), in pertinent part, as follows:
"It shall be unlawful for any.person, firm or corporation to:
* * * * * *
"4. Enter into any arrangement whereby prescription orders are received, or prescriptions delivered at a place other than the pharmacy in which they are compounded and dispensed. However, nothing in this paragraph shall prevent a pharmacist or his employee from personally receiving a prescription or delivering a legally filled prescription at a residence, office or place of employment of the patient for whom the prescription was written. Nothing in this paragraph shall prevent veterinary prescription drugs from being shipped directly from a wholesaler or distributor to a client; provided, such drugs may be dispensed only on prescription of a licensed veterinarian and only when an existing veterinary-client-Patient relationship exists."
2001 Okla. Sess. Laws ch. 400, sec 8.
These amendments modify Oklahoma law by authorizing a "wholesaler" or "distributor" of veterinary prescription drugs to ship the veterinary prescription drugs directly to a client. These amendments do not change or modify the requirement that veterinary prescription drugs must be prescribed by a veterinarian, pursuant to a valid veterinarian-client-patient relationship. See OAC 775:10-5-30(f)(3). Likewise, the amendments do not modify the requirement that before a veterinary prescription drug is dispensed, it must be certified by a pharmacist. See 59 O.S. 353.13 (A) (2001). The certification process does not interfere with or prevent the veterinary prescription drugs from being shipped directly to the client.
The Oklahoma Pharmacy Act requires a registered pharmacist or assistant pharmacist to "certify the finished prescription" before "delivery to the patient or the patient's agent or care giver." 59 O.S. 353.13 (A) (2001). The Pharmacy Board's administrative rules define the term "certify a prescription" as follows:
"The confirmation by the supervising pharmacist of the accuracy and completeness of the acts, tasks or functions undertaken by pharmacy technicians or supportive personnel to assist the pharmacist in the practice of pharmacy. This process shall be completed before the prescription is given to the patient."
OAC 535:15-13-3.
The recent legislation, Senate Bill 466, modified the existing law to allow wholesalers to ship veterinary prescription drugs directly to a veterinarian's client. The modifications, however, did not modify the method by which such prescriptions are to be filled, labeled, and certified. The Oklahoma Veterinary Administrative Rules at, OAC,775:25-1-3(a), (e) (2001), provide the labeling requirements for veterinary prescription drugs.
It should be noted that in addition to a pharmacist, a veterinarian may fill and dispense a prescription for a veterinary prescription drug to that veterinarian's patient where a valid veterinarian-client-patient relationship exists. See 59 O.S. 355.1 (A) (2001); OAC 775:10-5-30(f)(3).
It is, therefore, the official Opinion of the Attorney General that:
1. As of November 1; 2041, a drug "wholesaler" or "distributor," as those terms are defined by. Senate Bill 466 (2001 Okla. Sess. Laws ch. 400, sec 6(15), amending 59 O.S. 353.1 (15) (2000)), may ship a veterinary prescription drug directly to a veterinarian's client, provided such drugs are dispensed only,on,prescription of the licensed veterinarian.
2. The Oklahoma Pharmacy Act requires a registered pharmacist or assistant pharmacist to "certify the finished prescription" before "delivery to the patient or the patient's agent or care giver." 59 O.S. 353.13 (A) (2001). Accordingly, a pharmacist must "certify" a prescription for a veterinary prescription drug before a "wholesaler" or "distributor" of the veterinary prescription drug ships the drug to the patient or the patient's care giver.
( Gretchen Zumwalt-Smith )
(FOOTNOTES):
1 Senate Bill 466 amended the definition of the terms "wholesaler" or "distributor." See 2001 Okla.Sess.Laws ch. 400, 6(15).
Match Number: 10 of 70
Score: 21
ENTRY_DATE: 110101
APPELLANT: Cathy Kirkpatrick Board of Veterinary Medical Examiners
JURISDICTION: Attorney General of Oklahoma - Opinion
HEARING_DATE: October 25, 2001
TEXT_OF_RULE:
This office has received your request for an official Attorney General Opinion in which you ask, in effect, the following question:
Do Sections 6 through 8 of Senate Bill 466 (2001 Okla. Sess. Laws ch. 400, secs 6 - 8, effective November 1, 2001, amending 59 O.S. 353.1 , 59 O.S. 353.13 , 59 O.S. 353.24 (2000)) allow wholesalers or distributors of veterinary prescription drugs to dispense such drugs directly to a veterinarian's client?
I. INTRODUCTION
Your question relates to dispensing veterinary prescription drugs. We addressed this issue earlier in Attorney General Opinion 01-021, and in part stated that a feed store or wholesale distributor may not sell or ship a veterinary prescription drug directly to a client. Id. at 105. You ask what effect, if any, this recent legislation has on the questions addressed in that Opinion.
In A.G. Opin. 01-021, we answered:
"1. Only a pharmacist or veterinarian may lawfully fill and dispense a prescription, or an order, for a veterinary prescription drug which falls within the Pharmacy Act's definitions of "dangerous drug," "legend drug" or "prescription drug." 59 O.S. 355 , 59 O.S. 355.1 (A), 59 O.S. 353.18 (A) (2000); OAC 535:15-3-11(a) (1996).
* * * * * *
"4. Neither a drug wholesaler nor a feed or farm store is authorized to sell a veterinary prescription drug directly to the public. 59 O.S. 353.1 (15), 59 O.S. 355.1 (A), 59 O.S. 353.24 (4) (2000); OAC 530:20-7-1-20-7-9 (1996)."
Id. at 105.
Senate Bill 466 becomes effective on November 1, 2001. This bill changes the law relating to the distribution, i.e. the sale, of veterinary prescription drugs.
II. SENATE BILL 466 AMENDMENTS
In general, the State law which governs dispensing drugs, whether human or animal, is the Oklahoma Pharmacy Act, 59 O.S. 355 - 51 O.S. 366 (1991-2000) ("Pharmacy Act"). Senate Bill 466 amended the Pharmacy Act's definition of "wholesaler" or "distributor" as follows:
""Wholesaler" or "Distributor" means a person engaged in the business of distributing dangerous drugs or medicines at wholesale to pharmacies
, hospitals, practitioners, government agencies, or other lawful drug outlets permitted to sell or use drugs or medicines, or as authorized in subsection G of Section 353.13 of this title."
2001 Okla. Sess. Laws ch. 400 sec 6(15) (amending 59 O.S. 353.1 (15) (2000)). Senate Bill 466, sec 7(G) added Section 353.13(G) as follows:
"Nothing in the Oklahoma Pharmacy Act shall prevent veterinary prescription drugs from being shipped directly from a wholesaler or distributor to a client provided such drugs may be dispensed only prescription of a licensed veterinarian and only when an existing veterinary-client-patient relationship exists."
2001 Okla. Sess. Laws ch. 400 sec 7(G) (amending 59 O.S. 353.13 (2000)). Also, Senate Bill 466 amended Section 353.24 as follows:
"It shall be unlawful for any person, firm or corporation to:
* * * * * *
"4. Enter into any arrangement whereby prescription orders are received, or prescriptions delivered at a place other than the pharmacy in which they are compounded and dispensed. However, nothing in this paragraph shall prevent a pharmacist or his employee from personally receiving a prescription or delivering a legally filled prescription at a residence, office or place of employment of the patient for whom the prescription was written. Nothing in this paragraph shall prevent veterinary prescription drugs from being shined directly from a wholesaler or distributor to a client provided such drums may be dispensed once on prescription of a licensed veterinarian and only when an existing veterinary-client patient relationship exists."
2001 Okla. Sess. Laws ch. 400 sec 8 (amending 59 O.S. 353.24 (2000)). These amendments modify Oklahoma law by authorizing a "wholesaler" or "distributor" of veterinary prescription drugs to ship the veterinary prescription drugs directly to a client.1 These amendments do not change or modify the requirement that veterinary prescription drugs must be prescribed by a veterinarian pursuant to a valid veterinary-client-patient relationship.2
III. FEDERAL LAW DOES NOT PROHIBIT A WHOLESALER OR DISTRIBUTOR FROM SHIPPING A VETERINARY PRESCRIPTION DRUG DIRECTLY TO A CLIENT
The Sixth Circuit addressed the issues of prescribing and dispensing veterinary prescription drugs in the case of United States v. Colahan, 811 F.2d 287 (6th Cir. 1987). There, the Sixth Circuit made it clear that under federal law a veterinarian must issue a prescription or order for a veterinary prescription drug. Id. at 294. However, if allowed by a particular state law, that prescription or order could be filled by a non-pharmacist. Id.
The appellants in Colahan argued that in 21 C.F.R. sec 201.105(a)(1), the use of the phrase "prescription or other order of a licensed veterinarian" allowed greater flexibility in the distribution of veterinary prescription drugs than human prescription drugs. Calahan, 811 F.2d at 293. However that greater flexibility was limited. The Court stated that the phrase "order of a licensed veterinarian" was used "so as not to interfere with the practice, legal in several states, for food stores, animal health stores, and other outlets who do not employ pharmacists to sell restricted drugs on veterinarians' orders." Id. at 294. The Court went on to explain that "the difference between prescription and order was intended to accommodate the difference between pharmacist and nonpharmacist vendors and not to indicate a relaxation in the manner in which the veterinarian's order could be communicated." Id. (citation omitted).
Accordingly, with the new amendments in the Pharmacy Act as provided for in Senate Bill 466, a "wholesaler" or "distributor," as those terms are defined by Section 6(15) of Senate Bill 466, may sell a veterinary prescription drug directly to a veterinarian's client, provided such drugs are dispensed only on a valid prescription of the licensed veterinarian. 2001 Okla. Sess. Laws ch. 400 sec 6(15) (amending 59 O.S. 353.1 (15) (2000)). A feed store is not a "wholesaler" or "distributor" unless it is "engaged in the business of distributing dangerous drugs or medicines at wholesale to pharmacies, hospitals, practitioners, government agencies, or other lawful drug outlets permitted to sell or use drugs or medicines." Id.
It is, therefore, the official Opinion of the Attorney General that:
1. Senate Bill 466 allows a veterinary drug "wholesaler" or "distributor," as those terms are defined by Section 6(15) of Senate Bill 466, to sell veterinary prescription drugs directly to a veterinarian's client, provided such drugs are dispensed only on prescription of the licensed veterinarian and only when an existing veterinary-client-patient relationship exists. 2001 Okla. Sess. Laws ch. 400 secs 6 - 8 (amending 59 O.S. 353.1 , 59 O.S. 353.13 , 59 O.S. 353.24 (2000)).
2. Attorney General Opinion 01-021 accurately reflects the law until November 1, 2001.
3. On November 1, 2001, the amendments of Senate Bill 466 take effect. Consequently, after November 1, 2001, a pharmacist or veterinarian may lawfully fill and dispense a prescription or an order for a veterinary prescription drug which falls within the Pharmacy Act's definitions of "dangerous drug," legend drug" or "prescription drug." 59 O.S. Supp. 355, 59 O.S. 355.1 (A), 59 O.S. 353.18 (A); OAC 535:15-3-11(a) (1996). A licensed veterinarian, however, may not dispense a prescription drug to an individual without a valid veterinarian-client-patient relationship. 59 O.S. 355.1 (2000); OAC 775:10-5-30(f)(3) (2000). As of November 1, 2001, a drug "wholesaler" or "distributor," as those terms are defined by Section 6 of Senate Bill 466, may sell a veterinary prescription drug directly to a veterinarian's client, provided such drugs are dispensed only on prescription of the licensed veterinarian. 2001 Okla. Sess. Laws ch. 400 sec 6(15) (amending 59 O.S. 353.1 (15) (2000)). A feed store is not a "wholesaler" or "distributor" unless it is "engaged in the business of distributing dangerous drugs or medicines at wholesale to pharmacies, hospitals, practitioners, government agencies, or other lawful drug outlets permitted to sell or use drugs or medicines." Id.
( Gretchen Zumwalt Smith )
(FOOTNOTES):
1 Oklahoma Administrative Rules describe the manner in which controlled dangerous substances and veterinary prescription drugs maybe dispensed. Such drugs maybe dispensed only on "order" or "written order" of a veterinarian and only when an existing veterinary-client-patient relationship exists. OAC 775:25-1-3(a), (c), (d) (2000). The Rules further provide that such drugs for use in food, or for administration to a food or commercial animal, may be shipped directly from the wholesaler to the client provided certain labeling conditions are met. OAC 775:25-1-3(d) (2000).
2 A "veterinarian-client-patient relationship" is defined at 59 O.S. 698.2 (10) (2000) as:
"a. The licensed veterinarian has assumed the responsibility for making medical judgments regarding the health of an animal or animals and the need for medical treatment, and the client, owner or other caretaker has agreed to follow the instructions of the licensed veterinarian; and
"b. there is sufficient knowledge of the animal or animals by the licensed veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal or animals in that:
"(1) the licensed veterinarian has recently seen or is personally acquainted with the keeping and care of the animal or animals, or
"(2) by medically necessary and timely visits to the premises where the animal or animals are kept or both, and
"c. the licensed veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy, or has arranged for emergency medical coverage, and
"d. would conform to applicable federal law and regulations." Id.
CITATIONS: 01-045 (2001) ag
Match Number: 4 of 70
Score: 39
Dear Ms. Kirkpatrick:
This office has received your request for an official Attorney General Opinion in which you ask, in effect, the following question:
May a "wholesaler" or "distributor" of veterinary prescription drugs, dispense a veterinary prescription drug directly to a veterinarian's client if the veterinary prescription drug. has never been "certified" by a pharmacist or other licensed practitioner?
This question arose because of recent legislation which allows a "wholesaler" or "distributor" of veterinary prescription drugs to dispense such drugs directly to a veterinarian's client.1 Stated more generally, the question is whether any employee of a "wholesaler" or "distributor" may fill and dispense a veterinary prescription drug - even if that employee is not a registered pharmacist. The answer is no.
Senate Bill 466 amended 59 O.S. 353.13 (2000) as follows:
"A. It shall be unlawful for~any person, other than a registered pharmacist or assistant pharmacist, to certify the finished prescription, as defined by the Board, before delivery ,to, the patient or the patient's agent or care giver.
"B. It shall be unlawful for any person to institute or manage a pharmacy unless such person shall be a registered pharmacist, or shall place in charge of said pharmacy are registered pharmacist.
"C. No registered pharmacist shall manage, supervise nor be in charge of more than one pharmacy.
"D. No pharmacist being requested to sell, furnish or compound any drug, medicine, chemical or other pharmaceutical preparation, by prescription or otherwise, shall substitute or cause to be substituted therefor, without authority of the prescriber or purchaser, any like drug, medicine, chemical or pharmaceutical preparation.
"E. No proprietor of a pharmacy, or other person, shall permit the practice of pharmacy except by a registered pharmacist or assistant pharmacist.
"F. No proprietor of a pharmacy, or other person, shall subvert the authority of the pharmacist in charge of the pharmacy by impeding the management of the prescription department in compliance with federal and state pharmacy laws and regulations.
"G. Nothing in the Oklahoma Pharmacy Act shall prevent veterinary prescription drugs from being shipped directly from a wholesaler or distributor to a client; provided, such drugs may be dispensed only on prescription of a licensed veterinarian and only when an existing veterinary-client-patient relationship exists."
2001 Okla. Sess. Laws ch. 400, sec 7.
Senate Bill 466 also amended 59 O.S. 353.24 (4) (2000), in pertinent part, as follows:
"It shall be unlawful for any.person, firm or corporation to:
* * * * * *
"4. Enter into any arrangement whereby prescription orders are received, or prescriptions delivered at a place other than the pharmacy in which they are compounded and dispensed. However, nothing in this paragraph shall prevent a pharmacist or his employee from personally receiving a prescription or delivering a legally filled prescription at a residence, office or place of employment of the patient for whom the prescription was written. Nothing in this paragraph shall prevent veterinary prescription drugs from being shipped directly from a wholesaler or distributor to a client; provided, such drugs may be dispensed only on prescription of a licensed veterinarian and only when an existing veterinary-client-Patient relationship exists."
2001 Okla. Sess. Laws ch. 400, sec 8.
These amendments modify Oklahoma law by authorizing a "wholesaler" or "distributor" of veterinary prescription drugs to ship the veterinary prescription drugs directly to a client. These amendments do not change or modify the requirement that veterinary prescription drugs must be prescribed by a veterinarian, pursuant to a valid veterinarian-client-patient relationship. See OAC 775:10-5-30(f)(3). Likewise, the amendments do not modify the requirement that before a veterinary prescription drug is dispensed, it must be certified by a pharmacist. See 59 O.S. 353.13 (A) (2001). The certification process does not interfere with or prevent the veterinary prescription drugs from being shipped directly to the client.
The Oklahoma Pharmacy Act requires a registered pharmacist or assistant pharmacist to "certify the finished prescription" before "delivery to the patient or the patient's agent or care giver." 59 O.S. 353.13 (A) (2001). The Pharmacy Board's administrative rules define the term "certify a prescription" as follows:
"The confirmation by the supervising pharmacist of the accuracy and completeness of the acts, tasks or functions undertaken by pharmacy technicians or supportive personnel to assist the pharmacist in the practice of pharmacy. This process shall be completed before the prescription is given to the patient."
OAC 535:15-13-3.
The recent legislation, Senate Bill 466, modified the existing law to allow wholesalers to ship veterinary prescription drugs directly to a veterinarian's client. The modifications, however, did not modify the method by which such prescriptions are to be filled, labeled, and certified. The Oklahoma Veterinary Administrative Rules at, OAC,775:25-1-3(a), (e) (2001), provide the labeling requirements for veterinary prescription drugs.
It should be noted that in addition to a pharmacist, a veterinarian may fill and dispense a prescription for a veterinary prescription drug to that veterinarian's patient where a valid veterinarian-client-patient relationship exists. See 59 O.S. 355.1 (A) (2001); OAC 775:10-5-30(f)(3).
It is, therefore, the official Opinion of the Attorney General that:
1. As of November 1; 2041, a drug "wholesaler" or "distributor," as those terms are defined by. Senate Bill 466 (2001 Okla. Sess. Laws ch. 400, sec 6(15), amending 59 O.S. 353.1 (15) (2000)), may ship a veterinary prescription drug directly to a veterinarian's client, provided such drugs are dispensed only,on,prescription of the licensed veterinarian.
2. The Oklahoma Pharmacy Act requires a registered pharmacist or assistant pharmacist to "certify the finished prescription" before "delivery to the patient or the patient's agent or care giver." 59 O.S. 353.13 (A) (2001). Accordingly, a pharmacist must "certify" a prescription for a veterinary prescription drug before a "wholesaler" or "distributor" of the veterinary prescription drug ships the drug to the patient or the patient's care giver.
( Gretchen Zumwalt-Smith )
(FOOTNOTES):
1 Senate Bill 466 amended the definition of the terms "wholesaler" or "distributor." See 2001 Okla.Sess.Laws ch. 400, 6(15).
Match Number: 10 of 70
Score: 21
This office has received your request for an official Attorney General Opinion in which you ask, in effect, the following question:
Do Sections 6 through 8 of Senate Bill 466 (2001 Okla. Sess. Laws ch. 400, secs 6 - 8, effective November 1, 2001, amending 59 O.S. 353.1 , 59 O.S. 353.13 , 59 O.S. 353.24 (2000)) allow wholesalers or distributors of veterinary prescription drugs to dispense such drugs directly to a veterinarian's client?
I. INTRODUCTION
Your question relates to dispensing veterinary prescription drugs. We addressed this issue earlier in Attorney General Opinion 01-021, and in part stated that a feed store or wholesale distributor may not sell or ship a veterinary prescription drug directly to a client. Id. at 105. You ask what effect, if any, this recent legislation has on the questions addressed in that Opinion.
In A.G. Opin. 01-021, we answered:
"1. Only a pharmacist or veterinarian may lawfully fill and dispense a prescription, or an order, for a veterinary prescription drug which falls within the Pharmacy Act's definitions of "dangerous drug," "legend drug" or "prescription drug." 59 O.S. 355 , 59 O.S. 355.1 (A), 59 O.S. 353.18 (A) (2000); OAC 535:15-3-11(a) (1996).
* * * * * *
"4. Neither a drug wholesaler nor a feed or farm store is authorized to sell a veterinary prescription drug directly to the public. 59 O.S. 353.1 (15), 59 O.S. 355.1 (A), 59 O.S. 353.24 (4) (2000); OAC 530:20-7-1-20-7-9 (1996)."
Id. at 105.
Senate Bill 466 becomes effective on November 1, 2001. This bill changes the law relating to the distribution, i.e. the sale, of veterinary prescription drugs.
II. SENATE BILL 466 AMENDMENTS
In general, the State law which governs dispensing drugs, whether human or animal, is the Oklahoma Pharmacy Act, 59 O.S. 355 - 51 O.S. 366 (1991-2000) ("Pharmacy Act"). Senate Bill 466 amended the Pharmacy Act's definition of "wholesaler" or "distributor" as follows:
""Wholesaler" or "Distributor" means a person engaged in the business of distributing dangerous drugs or medicines at wholesale to pharmacies
, hospitals, practitioners, government agencies, or other lawful drug outlets permitted to sell or use drugs or medicines, or as authorized in subsection G of Section 353.13 of this title."2001 Okla. Sess. Laws ch. 400 sec 6(15) (amending 59 O.S. 353.1 (15) (2000)). Senate Bill 466, sec 7(G) added Section 353.13(G) as follows:
"Nothing in the Oklahoma Pharmacy Act shall prevent veterinary prescription drugs from being shipped directly from a wholesaler or distributor to a client provided such drugs may be dispensed only prescription of a licensed veterinarian and only when an existing veterinary-client-patient relationship exists."
2001 Okla. Sess. Laws ch. 400 sec 7(G) (amending 59 O.S. 353.13 (2000)). Also, Senate Bill 466 amended Section 353.24 as follows:
"It shall be unlawful for any person, firm or corporation to:
* * * * * *
"4. Enter into any arrangement whereby prescription orders are received, or prescriptions delivered at a place other than the pharmacy in which they are compounded and dispensed. However, nothing in this paragraph shall prevent a pharmacist or his employee from personally receiving a prescription or delivering a legally filled prescription at a residence, office or place of employment of the patient for whom the prescription was written. Nothing in this paragraph shall prevent veterinary prescription drugs from being shined directly from a wholesaler or distributor to a client provided such drums may be dispensed once on prescription of a licensed veterinarian and only when an existing veterinary-client patient relationship exists."
2001 Okla. Sess. Laws ch. 400 sec 8 (amending 59 O.S. 353.24 (2000)). These amendments modify Oklahoma law by authorizing a "wholesaler" or "distributor" of veterinary prescription drugs to ship the veterinary prescription drugs directly to a client.1 These amendments do not change or modify the requirement that veterinary prescription drugs must be prescribed by a veterinarian pursuant to a valid veterinary-client-patient relationship.2
III. FEDERAL LAW DOES NOT PROHIBIT A WHOLESALER OR DISTRIBUTOR FROM SHIPPING A VETERINARY PRESCRIPTION DRUG DIRECTLY TO A CLIENT
The Sixth Circuit addressed the issues of prescribing and dispensing veterinary prescription drugs in the case of United States v. Colahan, 811 F.2d 287 (6th Cir. 1987). There, the Sixth Circuit made it clear that under federal law a veterinarian must issue a prescription or order for a veterinary prescription drug. Id. at 294. However, if allowed by a particular state law, that prescription or order could be filled by a non-pharmacist. Id.
The appellants in Colahan argued that in 21 C.F.R. sec 201.105(a)(1), the use of the phrase "prescription or other order of a licensed veterinarian" allowed greater flexibility in the distribution of veterinary prescription drugs than human prescription drugs. Calahan, 811 F.2d at 293. However that greater flexibility was limited. The Court stated that the phrase "order of a licensed veterinarian" was used "so as not to interfere with the practice, legal in several states, for food stores, animal health stores, and other outlets who do not employ pharmacists to sell restricted drugs on veterinarians' orders." Id. at 294. The Court went on to explain that "the difference between prescription and order was intended to accommodate the difference between pharmacist and nonpharmacist vendors and not to indicate a relaxation in the manner in which the veterinarian's order could be communicated." Id. (citation omitted).
Accordingly, with the new amendments in the Pharmacy Act as provided for in Senate Bill 466, a "wholesaler" or "distributor," as those terms are defined by Section 6(15) of Senate Bill 466, may sell a veterinary prescription drug directly to a veterinarian's client, provided such drugs are dispensed only on a valid prescription of the licensed veterinarian. 2001 Okla. Sess. Laws ch. 400 sec 6(15) (amending 59 O.S. 353.1 (15) (2000)). A feed store is not a "wholesaler" or "distributor" unless it is "engaged in the business of distributing dangerous drugs or medicines at wholesale to pharmacies
, hospitals, practitioners, government agencies, or other lawful drug outlets permitted to sell or use drugs or medicines." Id.It is, therefore, the official Opinion of the Attorney General that:
1. Senate Bill 466 allows a veterinary drug "wholesaler" or "distributor," as those terms are defined by Section 6(15) of Senate Bill 466, to sell veterinary prescription drugs directly to a veterinarian's client, provided such drugs are dispensed only on prescription of the licensed veterinarian and only when an existing veterinary-client-patient relationship exists. 2001 Okla. Sess. Laws ch. 400 secs 6 - 8 (amending 59 O.S. 353.1 , 59 O.S. 353.13 , 59 O.S. 353.24 (2000)).
2. Attorney General Opinion 01-021 accurately reflects the law until November 1, 2001.
3. On November 1, 2001, the amendments of Senate Bill 466 take effect. Consequently, after November 1, 2001, a pharmacist or veterinarian may lawfully fill and dispense a prescription or an order for a veterinary prescription drug which falls within the Pharmacy Act's definitions of "dangerous drug," legend drug" or "prescription drug." 59 O.S. Supp. 355, 59 O.S. 355.1 (A), 59 O.S. 353.18 (A); OAC 535:15-3-11(a) (1996). A licensed veterinarian, however, may not dispense a prescription drug to an individual without a valid veterinarian-client-patient relationship. 59 O.S. 355.1 (2000); OAC 775:10-5-30(f)(3) (2000). As of November 1, 2001, a drug "wholesaler" or "distributor," as those terms are defined by Section 6 of Senate Bill 466, may sell a veterinary prescription drug directly to a veterinarian's client, provided such drugs are dispensed only on prescription of the licensed veterinarian. 2001 Okla. Sess. Laws ch. 400 sec 6(15) (amending 59 O.S. 353.1 (15) (2000)). A feed store is not a "wholesaler" or "distributor" unless it is "engaged in the business of distributing dangerous drugs or medicines at wholesale to pharmacies, hospitals, practitioners, government agencies, or other lawful drug outlets permitted to sell or use drugs or medicines." Id.
( Gretchen Zumwalt Smith )
(FOOTNOTES):
1 Oklahoma Administrative Rules describe the manner in which controlled dangerous substances and veterinary prescription drugs maybe dispensed. Such drugs maybe dispensed only on "order" or "written order" of a veterinarian and only when an existing veterinary-client-patient relationship exists. OAC 775:25-1-3(a), (c), (d) (2000). The Rules further provide that such drugs for use in food, or for administration to a food or commercial animal, may be shipped directly from the wholesaler to the client provided certain labeling conditions are met. OAC 775:25-1-3(d) (2000).
2 A "veterinarian-client-patient relationship" is defined at 59 O.S. 698.2 (10) (2000) as:
"a. The licensed veterinarian has assumed the responsibility for making medical judgments regarding the health of an animal or animals and the need for medical treatment, and the client, owner or other caretaker has agreed to follow the instructions of the licensed veterinarian; and
"b. there is sufficient knowledge of the animal or animals by the licensed veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal or animals in that:
"(1) the licensed veterinarian has recently seen or is personally acquainted with the keeping and care of the animal or animals, or
"(2) by medically necessary and timely visits to the premises where the animal or animals are kept or both, and
"c. the licensed veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy, or has arranged for emergency medical coverage
, and"d. would conform to applicable federal law and regulations." Id.
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