Title 20-DEPARTMENT OF INSURANCE, FINANCIAL INSTITUTIONS AND PROFESSIONAL REGISTRATION

Division 2220-State Board of Pharmacy

Chapter 2-General Rules

PROPOSED RULE

20 CSR 2220-2.675 Standards of Operation/Licensure for Class L Veterinary Pharmacies

PURPOSE: This rule defines standards for a Class L veterinary pharmacy.

(1) A Class A or a Class L pharmacy permit shall be required for any entity engaged in the sale, dispensing, or filling of a legend drug for use in animals that must only be dispensed by prescription under state or federal law. For purposes of this rule, a legend drug shall be defined as provided by 21 USC section 353.

(2) Class A Pharmacies. Class A permit holders shall comply with all laws/rules applicable to Class A pharmacies, provided a Class A pharmacy shall comply with sections (7) and (8) of this rule when legend drugs are dispensed for animal use.

(3) Class L Pharmacies. A Class L pharmacy shall dispense, sell, or provide legend drugs only for animal use. Except as otherwise provided in this rule, a Class L pharmacy shall comply with all applicable state and federal pharmacy and controlled substance laws/rules including, but not limited to, all applicable provisions of Chapter 338, RSMo, and the rules of the board.

(4) Pharmacy Operations. A Class L pharmacy shall comply with 20 CSR 2220-2.010, with the following allowed modifications:

(A) The pharmacy permit shall be displayed in plain view at the pharmacy location;

(B) The pharmacy shall maintain sufficient space, equipment, and storage capabilities as necessary to carry out its operations;

(C) Legend drugs shall be properly identified and stored in a defined area within the pharmacy;

(D) Legend drugs shall be stored in a clean and sanitary designated area and within temperature requirements as provided for by the manufacturer or the latest edition of the United States Pharmacopoeia (USP);

(E) The pharmacy shall maintain a current reference manual related to veterinary drugs that complies with 20 CSR 2220-2.010(1)(D);

(F) Appropriate sewage disposal must be available within the pharmacy and a hot and cold water supply shall be accessible to pharmacy staff. If compounding is performed, the hot and cold water supply shall be located within the pharmacy;

(G) Pharmacy compounding shall comply with 20 CSR 2220-2.200, 20 CSR 2220-2.400, and all other applicable provisions of state/federal law;

(H) All dispensing errors shall be documented in the pharmacy's records;

(I) Animals shall not be allowed in the designated area where legend drugs are stored or maintained; and

(J) The pharmacist-in-charge shall be notified within twenty-four (24) hours after a dispensing error is learned by pharmacy staff. Documentation of notification shall be maintained in the pharmacy's prescription records.

(5) A Class L pharmacy shall designate a pharmacist-in-charge as required by 20 CSR 2220-2.010(1)(M). The pharmacist-in-charge shall be responsible for supervising pharmacy operations and ensuring compliance with the provisions of this rule and all applicable state/federal laws. Except as otherwise provided in this rule, the pharmacist-in-charge shall also-

(A) Ensure legend drugs are only sold, dispensed, or filled by the pharmacy for animal use;

(B) Ensure legend drugs have been ordered/prescribed by an authorized prescriber; and

(C) Maintain a policy and procedure manual for pharmacy operations. The policy and procedure manual shall be reviewed annually by the pharmacist-in-charge. The manual shall be available for inspection by board personnel and shall include policies and procedures for:

1. Accepting, compounding, dispensing, or filling prescriptions;

2. Accepting, dispensing, or filling prescriptions in the pharmacist's absence;

3. Drug storage and security;

4. Handling drug recalls;

5. Procedures for offering patient/client counseling;

6. If applicable, procedures for dispensing or providing prescriptions in a pharmacist's absence pursuant to section (8) of this rule;

7. Contacting the pharmacist-in-charge for consultation during the pharmacy's business operations or in the event of an emergency; and

8. Reporting and handling dispensing errors. The pharmacist-in-charge shall be notified of a dispensing error within twenty-four (24) hours after the error is learned by pharmacy staff. Policies/procedures shall include the manner of notification.

(6) A pharmacist shall not be required to be physically present onsite during the business operations of a Class L pharmacy if the pharmacist-in-charge reviews the activities and records of the pharmacy operations on a monthly basis to ensure compliance with this rule. This exemption shall not apply if the pharmacy sells, dispenses, or otherwise provides controlled substances. The date of the pharmacist-in-charge review shall be documented and maintained at the pharmacy.

(7) To be valid for purposes of dispensing, legend drug prescriptions for animal use shall conform to all requirements of sections 338.056 and 338.196, RSMo, and shall contain the following:

(A) The date issued;

(B) The client's/owner's name and the class, species, or identification of the animal, herd, flock, pen, lot, or other group being treated;

(C) The prescriber's name, if an oral prescription, or signature, if a written prescription;

(D) Name, strength, and dosage form of drug and directions for use;

(E) The number of refills, when applicable;

(F) The quantity prescribed in weight, volume, or number of units;

(G) The address of the prescriber and the patient when the prescription is for a controlled substance;

(H) Whether generic substitution has been authorized;

(I) The prescriber's Drug Enforcement Administration (DEA) number when the prescription is for a controlled substance; and

(J) Controlled substance prescriptions shall comply with all requirements of federal and state controlled substance laws.

(8) Dispensing. A Class L pharmacy may accept, fill, enter, dispense, or otherwise provide non-controlled legend drugs for animal use in the absence of a pharmacist, provided the pharmacist-in-charge shall review the prescription record for each such prescription on a monthly basis. The review shall be documented as provided in section (6) of this rule. For purposes of 20 CSR 2220-2.010(3), the dispensing pharmacist shall be identified as the pharmacist-in-charge unless dispensed by another licensed pharmacist.

(A) Legend drugs may only be compounded for use in animals when a pharmacist is present on site.

(B) Clients must be offered an opportunity to consult with a pharmacist as required by 20 CSR 2220-2.190. If the pharmacist is not present on site, a written offer to counsel with a contact telephone number for a pharmacist shall be supplied with the medication.

(9) Labeling. Prescriptions must be labeled as required by section 338.059, RSMo. Prescription labels may be manually written or numbered and shall include:

(A) The class, species, or identification of the animal, herd, flock, pen, lot, or other group being treated; and

(B) If applicable, the veterinarian's specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food which might be derived from the treated animal(s).

(10) Records. Class L pharmacy records shall be maintained as required by Chapter 338, RSMo, and the rules of the board, including 20 CSR 2220-2.018 and 20 CSR 2220-2.080.

(A) The information specified in section (7) of this rule shall be required and recorded on all handwritten, telephone, oral, and electronically produced prescriptions that are processed for dispensing by a pharmacist/pharmacy. If applicable, prescription records shall also include the veterinarian's specified withdrawal, withholding, or discard time identified in section (9) of this rule.

(B) Any change or alteration made to the prescription dispensed based on contact with the prescriber shall be documented in the pharmacy's prescription records. This shall include, but is not limited to, a change in quantity, directions, number of refills, or authority to substitute a drug.

(C) The pharmacy's prescription records shall identify any prescription dispensed in a pharmacist's absence pursuant to subsection (8)(B) of this rule.

(11) A Class L pharmacy shall comply with all applicable state or federal controlled substance laws.

(12) The provisions of this rule shall not be applicable to the sale of medication for use in animals that may lawfully be dispensed without a prescription nor shall this rule be construed to require licensure for entities solely engaged in selling, dispensing, or providing medications authorized for dispensing without a prescription.

(13) The provisions of this rule shall not prohibit or interfere with any legally registered practitioner of veterinary medicine in the compounding, administering, prescribing, or dispensing of their own prescriptions, medicine, drug, or pharmaceutical product to be used for animals.

AUTHORITY: sections 338.056, 338.059, 338.196, 338.250, 338.280, and 338.343, RSMo 2000, and sections 338.010, 338.055, 338.140, 338.150, 338.210, 338.220, and 338.240, HB 412 and SB 325, First Regular Session, Ninety-sixth General Assembly, 2011. Emergency rule filed Aug. 29, 2011, effective Sept. 8, 2011, expires March 5, 2012. Original rule filed Aug. 29, 2011.

PUBLIC COST: This proposed rule will cost state agencies or political subdivisions approximately fifty-one thousand one hundred twenty-seven dollars ($51,127) to sixty-four thousand four hundred eighty-four dollars ($64,484) in the first year of implementation, twelve thousand seven hundred eighty-two dollars ($12,782) to sixteen thousand one hundred twenty-one dollars ($16,121) annually thereafter, and sixty-three thousand one hundred twenty-six dollars ($63,126) to eighty-two thousand seven hundred eight dollars ($82,708) biennially thereafter for the life of the rule. It is anticipated that the costs will recur for the life of the rule, may vary with inflation, and are expected to increase at the rate projected by the Legislative Oversight Committee.

PRIVATE COST: This proposed rule will cost private entities approximately six hundred forty-two thousand six hundred sixty dollars ($642,660) in the first year of implementation, five hundred seventy-five thousand sixty-one dollars ($575,061) annually thereafter, and one hundred thirty-nine thousand sixty-three dollars ($139,063) biennially thereafter for the life of the rule. It is anticipated that the costs will recur for the life of the rule, may vary with inflation, and are expected to increase at the rate projected by the Legislative Oversight Committee.

NOTICE TO SUBMIT COMMENTS: Anyone may file a statement in support of or in opposition to this proposed rule with the Missouri Board of Pharmacy, PO Box 625, 3605 Missouri Boulevard, Jefferson City, MO 65102, by facsimile at (573) 526-3464, or via email at pharmacy@pr.mo.gov. To be considered, comments must be received within thirty (30) days after publication of this rule in the Missouri Register. No public hearing is scheduled.

PUBLIC FISCAL NOTE

I. RULE NUMBER

Title 20 - Department of Insurance, Financial Institutions and Professional Registration

Division 2220 - Board of Pharmacy

Chapter 2 - General Rules

Proposed Rule - 20 CSR 2220-2,675 Standards of Operation/Licensure for Class L Veterinary Pharmacies

Prepared August 23, 2011 by the Division of Professional Registration

II. SUMMARY OF FISCAL IMPACT

Net Effect on Board of Pharmacy Fund

 

 

Board of Pharmacy

1st Year of Implementation of Rule Increase to Fund

$25,516.03 to $38,873.32

 

Annual Increase to Fund Beginning After 1st Year

$6,379.01 to $9,718.33

 

Biennial Increase to Fund

$52,291.92 to $71,874.35

Estimated Revenue for the Missouri Board of Pharmacy

 

1st Year of Implementation of Rule

$90,000.00

Annual Revenue After 1st Year

$22,500.00

Biennial Revenue

$135,000.00

Estimated Costs for the Missouri Board of Pharmacy

 

1st Year of Implementation of Rule

$51,126.68 to $64,483.97

Annual Costs Beginning After 1st Year

$12,781.67 to $16,120.99

Biennial Costs

$63,125-65 to $82,708.08

III. WORKSHEET

ESTIMATED REVENUE - See Private Entity Fiscal Note

ESTIMATED COSTS

1st Year of Implementation

Personal Service Dollars (Y1)

The following individuals will review and process initial Class L permit applications and inspect the facilities for compliance with the statutes and regulations of the board.

Licensure Technician II -responsible for processing and reviewing initial Class L permit applications.

Pharmaceutical Consultant - responsible for initial inspection of pharmacies to ensure compliance with board of pharmacy statutes and regulations.

STAFF

ANNUAL SALARY RANGE

SALARY TO INCLUDE FRINGE BENEFIT

HOURLY SALARY

COST PER MINUTE

TIME PER LICENSEE

COST PER APPLICATION

NUMBER OF ITEMS

TOTAL COST

Licensure Technician II

$24,576 to $26,640

$37,439 to $40,583

$18,00 to $19.51

$0.30 to $0.33

1 hour

$18,00 to $19,51

300 Class L Applicants

$5,399.87 to $5,853,37

Pharmaceutical Consultant

$65,676 to $95,040

$100,051 to $144,784

$48,10 to $69.61

. $0.80 to $1.16

2 hours

$96.20 to $139.22

300 Class L Applicants

$28,860,81 to $41,764.60

 

 

 

 

 

Total Personal Service Costs

$34,260.68 to $47,617.97

Expense and Equipment Dollars (Y1)

Item

Cost

Quantity

Total Cost Per Item

Permit Printing and Postage

$0.72

300

$216.00

Inspection Travel Costs

$55.50

300

$16,650.00

 

Total Expense and Equipment Costs

$16,866.00

Annual Costs After 1st Year of Implementation

Personal Service Dollars (Annual After Y1)

The following individuals will review and process initial Class L permit applications and inspect the facilities for compliance with the statutes and regulations of the board.

Licensure Technician II -responsible for processing and reviewing initial Class L permit applications.

Pharmaceutical Consultant - responsible for initial inspection of pharmacies to ensure compliance with board of pharmacy statues and regulations.

STAFF

ANNUAL SALARY RANGE

SALARY TO INCLUDE FRINGE BENEFIT

HOURLY SALARY

COST PER MINUTE

TIME PER LICENSEE

COST PER APPLICATION

NUMBER OF ITEMS

TOTAL COST

Licensure Technician H

$24,576 to $26,640

$37,439 to $40,583

$18.00 to $19.51

$0.30 To $0.33

1 hour

$18.00 to $19.51

75 Class L Applicants

$1,349.97 to $1,463.34

Pharmaceutical Consultant

$65,676 to $95,040

$100,051 to $144,784

$48,10 to $69.61

$0.80 to $1.16

2 hours

$96.20 to $139.22

75 Class L Applicants

$7,215.20 to $10,441.15

 

 

 

 

 

Total Personal Service Costs

$8,565.17 to $11,904.49

Expense and Equipment Dollars (Annual After Y1)

Item

Cost

Quantity

Total Cost Per Item

Permit Printing and Postage

$072

75

$54.00

Inspection Travel Costs

$55,50

75

$4,162.50

 

Total Expense and Equipment Costs

$4,216.50

Biennial Costs

Personal Service Dollars (Biennial)

The following individuals will review and process Class L renewal applications and perform routine inspection of these facilities. The board currently inspects pharmacies once every 12-18 months so these costs are shown here.

Licensure Technician II -responsible for processing and reviewing designated renewal applications.

Pharmaceutical Consultant - responsible for routine inspection of pharmacies to ensure compliance with board of pharmacy statutes and regulations.

STAFF

ANNUAL SALARY RANGE

SALARY TO INCLUDE FRINGE BENEFIT

HOURLY SALARY

COST PER MINUTE

TIME PER LICENSEE

COST PER APPLICATION

NUMBER OF ITEMS

TOTAL COST

Licensure technician II

$24,576 to $26,640

$37,439,08 to $40,583.38

$18.00 to $19.51

$0.30 to $0.33

30 minutes

$9,00 to $9.76

300 Class L Renewals

$2,699,93 to $2,926,69

Pharmaceutical Consultant

$65,676 to $95,040

$100,050,82 to $144,783.94

$48,10 to $69.61

$0.80 to $1.16

3 hours

$144.30 to $208.82

300 Class L Pharmacies

$43,291,22 to $62,646.90

 

 

 

 

 

Total Personal Service Costs

$45,99L15 to $65,573,58

Expense and Equipment Dollars (Biennial)

Item

Cost

Quantity

Total Cost Per Item

Permit Printing and Postage

$0,72

300

$216,00

Renewal Postcard Notices and Postage

$0.36

300

$108,00

Paper Renewal and Postage Costs

$5-35

30

$160.50

Routine Inspection Travel Costs

$55,50

300

$16,650,00

 

Total Expense and Equipment Costs

$17,134.50

IV. ASSUMPTIONS

1. The estimated revenue is based on the application fees received for Class L permits which are reflected in the private entity fiscal note that is being filed with this rule,

2. The public fiscal note for this rule only reflects the cost for this particular process. However, private entity fees are set at an amount to cover the total actual costs incurred by the office, which includes personal service, expense and equipment, and transfers.

3. Employee's salaries were calculated using the annual salary multiplied by 52.34% for fringe benefits and then divided by 2080 hours per year to determine the hourly salary. The hourly salary was then divided by 60 minutes to determine the cost per minute. The cost per minute was then multiplied by the amount of time individual staff spent on the processing of the specified item. The total cost was based on the cost per item multiplied by the estimated number of items.

4. Currently, veterinary pharmacies as defined by § 338,220 and § 338.240, RSMo, are unregulated in Missouri. Accordingly, the exact number of potential applicants/permit holders is unknown. The board's estimation of potential applicants/permit holders is based on the board's research of publicly available contact information for veterinary pharmacies/animal supply stores operating in Missouri. Based on the information gathered, the board identified approximately 475 veterinary pharmacies/animal supply stores. After discussions with members/representatives of the Missouri Veterinary Board, the Missouri Drug Distributor Advisory Committee, the Missouri Veterinary Association, and Missouri Farm Bureau, the board estimates approximately 300 of the 475 identified entities will require licensure. The board was advised that the actual number of applicants/permit holders may be significantly lower. After the 1st year of implementation, the board estimates approximately 75 new Class L applicants annually.

5. In lieu of mailing paper renewal applications, the board mails renewal notices by postcard with online renewal instructions. However, permit holders may opt to receive a paper renewal. Less than 10% of the board's current permit holders request a paper renewal. Accordingly, the board estimates mat a maximum of 10% of the potential Class L permit holders will request a paper renewal resulting in postage costs (10% of 300 applicants = 30 paper renewal requests).

6. The pharmaceutical consultants that act as inspectors for the board are located throughout the state in assigned territories. The total time estimated for inspection activities includes the complete estimated time for travel and inspection. The inspection travel expenses are based on gas expenses for an average round-trip of 150 miles at $0.37 per mile.

7. It is anticipated that the total revenue and costs will recur annually or biennially as specified above for the life of the rule, may vary with inflation, and is expected to increase at the rate projected by the Legislative Oversight Committee.

PRIVATE FISCAL NOTE

I. RULE NUMBER

Title 20 - Department of Insurance, Financial Institutions and Professional Registration

Division 2220 - Board of Pharmacy

Chapter 2 - General Rules

Proposed Rule - 20 CSR 2220-2.675 Standards of Operation/Licensure for Class L Veterinary

Pharmacies

Prepared August 23, 2011 by the Division of Professional Registration

II. SUMMARY OF FISCAL IMPACT

 

Total Cost of Compliance for the Life of the Rule

 

Class L Permit Holders

1st Year of Implementation of Rule

$642,660.00

 

Annual Costs Beginning After 1st Year

$575,061.00

 

Biennial Costs

$139,063.20

III. WORKSHEET

1st Year of Implementation

Estimate the number of entities by class which would likely be affected by the adoption of the proposed rule:

Classification by type of the business entities which would likely be affected:

Estimated cost of compliance with the rule by affected entities:

300

Class L Pharmacy (Application Fee @ $300)

$90,000.00

300

Class L Pharmacy (Postage @ $0.44)

$132.00

300

Pharmacist in Charge Review Costs (Review @ $153.48/Month)

$552,528.00

 

Estimated Cost for 1st Year of Implementation of Rule

$642,660.00

Annual Costs Beginning After 1st Year

 

Classification by type of the business entities which would likely be affected:

Estimated cost of compliance with the rule by affected entities:

75

Class L Pharmacy (Application Fee @ $300)

$22,500.00

75

Class L Pharmacy (Postage @ $0.44)

$33.00

300

Pharmacist in Charge Review Costs (Review @ $153.48/Month)

$552,528.00

 

Estimated Annual Cost of Compliance for the Life of the Rule

$575,061.00

Biennial Costs

Estimate the number of entities by class which would likely be affected by the adoption of the proposed rule:

Classification by type of the business entities which would likely be affected;

Estimated cost of compliance with the rule by affected entities:

300

Class L Pharmacy (Renewal Fee @ $450)

$135,000.00

30

Class L Pharmacy (Postage @ $0.44)

$13.20

270

Class L Pharmacy (Online Renewal Vendor Processing Fee @$15)

$4,050.00

 

Estimated Biennial Cost of Compliance for the Life of the Rule

$139,063.20

IV. ASSUMPTION

1. The fees reported above are based on FY2009 - FY2010 actuals for other specialty pharmacy classifications licensed by the board.

2. Currently, veterinary pharmacies as defined by § 338.220 and § 338.240, RSMo, are unregulated in Missouri. Accordingly, the exact number of potential applicants/permit holders is unknown. The board's estimation of potential applicants/permit holders is based on the board's research of publicly available contact information for veterinary pharmacies/animal supply stores operating in Missouri. Based on the information gathered, the board identified approximately 475 veterinary pharmacies/animal supply stores. After discussions with members/representatives of the Missouri Veterinary Board, the Missouri Drug Distributor Advisory Committee, the Missouri Veterinary Association, and Missouri Farm Bureau, the board estimates approximately 300 of the 475 identified entities will require licensure. The board was advised that the actual number of applicants/permit holders may be significantly lower. After the 1st year of implementation, the board estimates approximately 75 new Class L applicants annually.

3. Permit renewals may be submitted online or mailed to the board. Based on the board's current percentage of online and paper renewals in FY2009 and FY2010 for other permit classifications, it is estimated that approximately 90% of Class L permit holders will renew online (approx. 270 permit holders) with an estimated 10% requesting a paper renewal (approx. 30 permit holders).

Permit holders submitting a paper renewal will incur related postage costs. Permit holders renewing online are required to pay an online renewal vendor processing fee. The processing fee is established by the state of Missouri's approved online payment vendor and is not established by, or paid to, the Board of Pharmacy. The vendor processing fee is based on currently assessed rates and may be subject to change by the vendor.

4. The rule requires a monthly review of a Class L pharmacy's activities and records if a pharmacist is not present during business operations or if prescriptions are dispensed in the pharmacist's absence by a pharmacist-in-charge. The United States Bureau of Labor Statistics estimates the median annual pharmacist wage/salary to be approximately $106,410 in the Occupational Outlook Handbook, 2010-2011 Edition. Based on the estimated annual salary, the board estimates an hourly pharmacist wage of $51.16. The board further estimated a minimum of 3 hours per month per Class L pharmacy for pharmacist-in-charge review. The pharmacy policy and procedure manual required by this rule will be written and provided by the pharmacist-in-charge. The pharmacist-in-charge's time for this can be figured into the 3 hour per month estimate.

5. It is anticipated that the total costs will recur annually or biennially as specified above for the life of the rule, may vary with inflation, and is expected to increase at the rate projected by the Legislative Oversight Committee.

NOTES: Although the compounding rules are referenced in subsection (4)(G) of this rule, the requirements and related costs are imposed by prexisting rules that apply to all pharmacies. Any Class L pharmacies that this applies to would have already been required to be licensed by existing rules. Therefore, new costs are not shown here.