4729-16-04 Drugs compounded by a prescriber.

 

 

 

Rule Summary and Fiscal Analysis (Part A)

 

State Board of Pharmacy

Agency Name

 

Cameron McNamee

Division                                                                  Contact

 

77 South High Street Room 1702 Columbus OH 43215-6126

614-466-7322

Agency Mailing Address (Plus Zip)                                       Phone                     Fax

[e-mail]

Email

4729-16-04

Rule Number

NEW

TYPE of rule filing

Rule Title/Tag Line              Drugs Compounded by a Prescriber.

RULE SUMMARY

1.  Is the rule being filed for five year review (FYR)? No

2.  Are you proposing this rule as a result of recent legislation? No

3.  Statute prescribing the procedure in accordance with the agency is required to adopt the rule: 119.03

4.  Statute(s) authorizing agency to adopt the rule: 4729.26, 3719.28

5.  Statute(s) the rule, as filed, amplifies or implements: 4729.01, 4729.541, 4729.55

6.  State the reason(s) for proposing (i.e., why are you filing,) this rule:

Compounded drugs, particularly those that are injected or ingested, must be prepared in conditions that ensure the sterility of the medication. Such regulations are necessary to protect patient safety and to ensure uniformity in preparing these drugs in Ohio.

7.  If the rule is an AMENDMENT, then summarize the changes and the content

of the proposed rule; If the rule type is RESCISSION, NEW or NO CHANGE, then summarize the content of the rule:

Provides the requirements for drugs compounded by a prescriber (except a veterinarian), such requirements include:

-Adherence to United States Pharmacopeia Chapter 795 for non-sterile drugs;

-Adherence to United States Pharmacopeia Chapter 797 for sterile drugs;

-Adherence to section 503A of the Federal Food, Drug, and Cosmetic Act for all compounded drugs; and

-Prescribers must oversee the compounding process, perform a final check of the drug, ensure proper labeling and record keeping.

These requirements ensure that drugs compounded by a prescriber meet the same requirements that are currently required for the same drugs prepared in a pharmacy.

8.  If the rule incorporates a text or other material by reference and the agency claims the incorporation by reference is exempt from compliance with sections

121.71 to 121.74 of the Revised Code because the text or other material is generally available to persons who reasonably can be expected to be affected by the rule, provide an explanation of how the text or other material is generally available to those persons:

This rule references the Ohio Revised Code and the Ohio Administrative Code. The

O.R.C. and O.A.C. are generally available in libraries and on the internet to persons who reasonably can be expected to be affected by the rule.

This rule also references the United States Code (U.S.C) and the United States Pharmacopeia (U.S.P.), which is a generally accepted industry standard for compounding drugs. The U.S.C. and U.S.P. are generally available in libraries and on the internet to persons who reasonably can be expected to be affected by the rule.

9.  If the rule incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material electronically, provide an explanation of why filing the text or other material electronically was infeasible:

Ohio Revised Code Sections 121.75 and 121.76 exempts these texts from inclusion in this filing.

10.  If the rule is being rescinded and incorporates a text or other material by

reference, and it was infeasible for the agency to file the text or other material, provide an explanation of why filing the text or other material was infeasible:

Not Applicable.

11.  If revising or refiling this rule, identify changes made from the previously filed version of this rule; if none, please state so. If applicable, indicate each specific paragraph of the rule that has been modified:

Rule is amended as follows:

(C) - Adds the phrase "For all compounded prescriptions" to the existing sentence.

(K) - Changes the phrase "responsible prescriber" to "responsible person". This matches existing terminology used by the Board.

12.  Five Year Review (FYR) Date:

(If the rule is not exempt and you answered NO to question No. 1, provide the scheduled review date. If you answered YES to No. 1, the review date for this rule is the filing date.)

NOTE: If the rule is not exempt at the time of final filing, two dates are required: the current review date plus a date not to exceed 5 years from the effective date for Amended rules or a date not to exceed 5 years from the review date for No Change rules.

FISCAL ANALYSIS

13.  Estimate the total amount by which this proposed rule would increase

/decrease either revenues /expenditures for the agency during the current biennium (in dollars): Explain the net impact of the proposed changes to the budget of your agency/department.

This will decrease expenditures.

$0.00

No net impact.

14.  Identify the appropriation (by line item etc.) that authorizes each expenditure necessitated by the proposed rule:

Not applicable.

15.  Provide a summary of the estimated cost of compliance with the rule to all directly affected persons. When appropriate, please include the source for your information/estimated costs, e.g. industry, CFR, internal/agency:

Provides the requirements for drugs compounded by a physician. This may result in increased compliance costs for prescribers who compound drug but do not meet national standards (i.e. United States Pharmacopeia Convention Chapter 795 and 797). This may include the cost of installing special rooms to compound sterile drugs, employee training, sterilization equipment and other improvements to ensure that drugs are compounded safely.

According to the Ohio Hematology Oncology Society (OHOS), the requirements in USP 797 for separate rooms for hazardous and non-hazardous drugs would require more space. Requirements for this additional space may not be readily available if the practice does not have the available square footage. Additionally, the OHOS also states that the required equipment to ensure the sterility of drugs prepared by prescribers is estimated to result in construction and installation costs ranging anywhere between $70,000 - $300,000 per practice, with annual expenditures for environmental testing at approximately $6,000 per site. The environmental testing is required by USP in order to maintain sterility and prevent contamination.

In addition, requiring the final check by the prescriber prior to personally furnishing or administration may result in increased administration costs to prescriber practices, as it currently deviates from existing practice.

16.  Does this rule have a fiscal effect on school districts, counties, townships, or municipal corporations? No

17.  Does this rule deal with environmental protection or contain a component dealing with environmental protection as defined in R. C. 121.39? No

S.B. 2 (129th General Assembly) Questions

18.  Has this rule been filed with the Common Sense Initiative Office pursuant to

R.C. 121.82? Yes

19.  Specific to this rule, answer the following:

A.) Does this rule require a license, permit, or any other prior authorization to engage in or operate a line of business? No

B.) Does this rule impose a criminal penalty, a civil penalty, or another sanction,

or create a cause of action, for failure to comply with its terms? Yes

Violation of the rules may result in administrative licensure discipline for a prescriber or location licensed as a terminal distributor of dangerous drugs. Discipline might include reprimand, suspension of a license, required course work, monetary penalty and/or revocation of a license.

C.) Does this rule require specific expenditures or the report of information as a condition of compliance? No