CABINET FOR HEALTH AND FAMILY SERVICES

Office of Inspector General

Division of Audits and Investigations

(Amendment)

 

††††† 902 KAR 55:090. Exempt anabolic steroid products.

 

††††† RELATES TO: KRS 218A.010-218A.250[218A.030, 218A.080-218A.090], 21 C.F.R. 1308.13, 1308.33-1308.34, 21 U.S.C. 801, 812

††††† STATUTORY AUTHORITY: KRS 218A.020

††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020 authorizes the Cabinet for Health and Family Services to add, delete, or reschedule substances enumerated in KRS Chapter 218A. This administrative regulation exempts certain anabolic steroid products from the licensing, distribution,[and] recordkeeping, and reporting provisions of KRS Chapter 218A if the products have received approval as an exempt anabolic steroid product pursuant to 21 C.F.R. 1308.34.

 

††††† Section 1. Exempt Anabolic Steroid Products. The Cabinet for Health and Family Services exempts anabolic steroid products from the licensing, distribution, recordkeeping, and reporting provisions of KRS 218A.150 Ė 218A.172, 218A.180, 218A.200, and 218A.202 if the products have received approval as exempt anabolic steroid products pursuant to 21 C.F.R. 1308.34[the following anabolic steroid containing compounds, mixtures, or preparations from the provisions of KRS 218A.150 Ė 218A.180 and 218A.200: (1) Androgyn L.A., vial, NDC number 0456-1005: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (2) Andro-Estro 90-4, vial, NDC number 0536-1605: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (3) Component E-H in process granulation, pail or drum: testosterone propionate 10 parts, estradiol benzoate 1 part;

††††† (4) Component E-H in process pellets, pail: testosterone propionate 25 mg, estradiol benzoate 2.5 mg/pellet;

††††† (5) Component TE-S in process granulation, pail or drum: trenbolone acetate 5 parts, estradiol USP 1 part;

††††† (6) Component TE-S in process pellets, pail: trenbolone acetate 120 mg, estradiol USP 24 mg/pellet;

††††† (7) DepANDROGYN, vial, NDC number 0456-1020: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (8) DEPO-T.E., vial, NDC number 52765-257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (9) Depo-Testadiol, vial, NDC number 0009-0253; testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (10) depTESTROGEN, vial, NDC number 51698-257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (11) Duomone, vial, NDC number 52047-360: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (12) DURATESTRIN, vial, NDC number 43797-016: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (13) DUO-SPAN II, vial, NDC number 0684-0102: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (14) Estratest, tablet, NDC number 0032-1026: esterified estrogens 1.25 mg, methyltestosterone 2.5 mg;

††††† (15) Estratest HS, tablet, NDC number 0032-1023: esterified estrogens 0.625 mg, methyltestosterone 1.25 mg;

††††† (16) Menogen, tablet, NDC number 59243-0570: esterified estrogens 1.25 mg, methyltestosterone 2.5 mg.;

††††† (17) Menogen HS, tablet, NDC number 59243-0560: esterified estrogens 0.625 mg, methyltestosterone 1.25 mg.;

††††† (18) PAN ESTRA TEST, vial, NDC number 0525-0175: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (19) Premarin with Methyltestosterone, tablet, NDC number 0046-0879: conjugated estrogens 1.25 mg, methyltestosterone 10.0 mg;

††††† (20) Premarin with Methyltestosterone, tablet, NDC number 0046-0878: conjugated estrogens 0.625 mg, methyltestosterone 5.0 mg;

††††† (21) Synovex H in-process bulk pellets, drum: testosterone propionate 25 mg., estradiol benzoate 2.5 mg.;

††††† (22) Synovex H Pellets in-process granulation, drum: testosterone propionate 10 parts, estradiol benzoate 1 part;

††††† (23) Synovex Plus, in-process bulk pellets, drum: trenbolone acetate 25 mg., estradiol benzoate 3.5 mg/pellet;

††††† (24) Synovex Plus, in-process ganulation, drum: trenbolone acetate 25 parts, estradiol benzoate 3.5 parts;

††††† (25) TEST-ESTRO Cypionates, vial, NDC number 0536-9470: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (26) Testagen, vial, NDC number 55553-257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (27) Testoderm, 4 mg/d, patch, NDC number 17314-4608: testosterone 10 mg.;

††††† (28) Testoderm, 6 mg/d, patch, NDC number 17314-4609: testosterone 15 mg.;

††††† (29) Testoderm, with Adhesive, 4 mg/d, patch, export only: testosterone 10 mg;

††††† (30) Testoderm, with Adhesive, 6 mg/d, patch, NDC number 17314-2836: testosterone 15 mg.;

††††† (31) Testoderm, in-process film, sheet: testosterone 0.25 mg/cm≤;

††††† (32) Testoderm, with Adhesive, in-process film, sheet: testosterone 0.25 mg/cm≤;

††††† (33) Testosterone Cyp 50 Estradiol Cyp 2, vial, NDC number 0814-7737: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (34) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 54274-530: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (35) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 0182-3069: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (36) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 0364-6611: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (37) Testosterone Cypionate-Estradiol Cypionate Injection, vial, NDC number 0402-0257: testosterone cypionate 50 mg/ml, estradiol cypionate 2 mg/ml;

††††† (38) Testosterone Enanthate-Estradiol Valerate Injection, vial, NDC number 0182-3073: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (39) Testosterone Enanthate-Estradiol Valerate Injection, vial, NDC number 0364-6618: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (40) Testosterone Enanthate-Estradiol Valerate Injection, vial, NDC number 0402-0360: testosterone enanthate 90 mg/ml, estradiol valerate 4 mg/ml;

††††† (41) Testosterone Ophthalmic Solutions, ophthalmic solutions: testosterone <0.6%w/v;

††††† (42) Tilapia Sex Reversal Feed (Investigational), Rangen, Inc., plastic bags: methyltestosterone 60 mg/kg fish feed; and

††††† (43) Tilapia Sex Reversal Feed (Investigational), Zeigler Brothers, Inc, plastic bags: methyltestosterone 60 mg/kg fish feed.]

 

CONNIE PAYNE, Acting Executive Director

AUDREY TAYSE HAYNES, Secretary

††††† APPROVED BY AGENCY: April 11, 2014

††††† FILED WITH LRC: April 11, 2014 at 3 p.m.

††††† PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on May 21, 2014, at 9:00 a.m. in Auditorium A, Health Services Building, First Floor, 275 East Main Street, Frankfort, Kentucky. Individuals interested in attending this hearing shall notify this agency in writing by May 14, 2014, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. The hearing is open to the public. Any person who attends will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to attend the public hearing, you may submit written comments on the proposed administrative regulation. You may submit written comments regarding this proposed administrative regulation until close of business, June 2, 2014. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to:

††††† CONTACT PERSON: Tricia Orme, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40621, phone (502) 564-7905, fax (502) 564-7573, email tricia.orme@ky.gov

 

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

 

Contact Persons: Connie Payne, Stephanie Hold, Stephanie Brammer-Barnes

††††† (1) Provide a brief summary of:

††††† (a) What this administrative regulation does: This administrative regulation exempts certain anabolic steroid products from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A if the products have been exempted by the Drug Enforcement Administration (DEA) from the application of certain provisions of the federal Controlled Substances Act pursuant to 21 C.F.R. 1308.34.

††††† (b) The necessity of this administrative regulation: This administrative regulation is necessary to exempt certain prescription products from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A.

††††† (c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms to the content of KRS 218A.020 by establishing Kentuckyís exempt anabolic steroid products.

††††† (d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation assists in the effective administration of the statutes by establishing Kentuckyís exempt anabolic steroid products.

††††† (2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

††††† (a) How the amendment will change this existing administrative regulation: This amendment deletes the obsolete list of exempt anabolic steroid products in Kentucky, and adds language to clarify that those anabolic steroid products which are exempt from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A shall be the same products that have received approval from the DEA for exemption from the application of certain provisions of the federal Controlled Substances Act pursuant to 21 C.F.R. 1308.34.

††††† (b) The necessity of the amendment to this administrative regulation: This amendment is necessary to ensure consistency between state and federal regulations which exempt certain anabolic steroid products from the licensing, distribution, recordkeeping, and reporting provisions of the state and federal Controlled Substances Acts.

††††† (c) How the amendment conforms to the content of the authorizing statutes: This amendment conforms to the content of the authorizing statutes by ensuring consistency between state and federal regulations related to exempt anabolic steroid products.

††††† (d) How the amendment will assist in the effective administration of the statutes: This amendment assists in the effective administration of the statutes by ensuring consistency between this administrative regulation and 21 C.F.R 1308.34.

††††† (3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: This amendment affects Kentuckyís pharmacists who rely on state and federal regulations for information regarding exempt anabolic steroid products.

††††† (4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

††††† (a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: Under this amendment, Kentuckyís pharmacists will use the DEAís most current Exempt Anabolic Steroid Products List to ensure compliance with both this administrative regulation and federal regulations.

††††† (b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): No costs will be incurred by any pharmacies for compliance with this amendment.

††††† (c) As a result of compliance, what benefits will accrue to the entities identified in question (3): By making Kentuckyís exempt anabolic steroid products list consistent with the DEAís exempt anabolic steroid products list, this amendment reduces confusion for pharmacists who rely on state and federal regulations for such information.

††††† (5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:

††††† (a) Initially: No costs are necessary to implement this amendment.

††††† (b) On a continuing basis: No costs are necessary to implement this amendment.

††††† (6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: No additional funding is necessary to implement this administrative regulation.

††††† (7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No fees or funding will be necessary to implement this administrative regulation.

††††† (8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees: This administrative regulation does not establish or increase any fees.

††††† (9) TIERING: Is tiering applied? Tiering is not applicable as compliance with this administrative regulation applies equally to all individuals or entities who elect to be regulated by it.

 

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

 

††††† 1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? This administrative regulation affects Kentuckyís pharmacists who rely on state and federal regulations for information regarding exempt anabolic steroid products.

††††† 2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation. KRS 218A.020, 21 C.F.R. 1308.33-1308.34

††††† 3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

††††† (a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? This amendment will not generate additional revenue for state or local government during the first year.

††††† (b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? This amendment will not generate additional revenue for state or local government during subsequent years.

††††† (c) How much will it cost to administer this program for the first year? No additional costs are necessary to administer this program during the first year.

††††† (d) How much will it cost to administer this program for subsequent years? No additional costs are necessary to administer this program for subsequent years.

††††† Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

††††† Revenues (+/-):

††††† Expenditures (+/-):

††††† Other Explanation

 

FEDERAL MANDATE ANALYSIS COMPARISON

 

††††† 1. Federal statute or regulation constituting the federal mandate.

21 C.F.R. 1308.33-1308.34

††††† 2. State compliance standards. KRS 218A.020(3)

††††† 3. Minimum or uniform standards contained in the federal mandate. 21 C.F.R. 1308.33 provides an application procedure whereby any person may apply for exemption for anabolic steroid products which meet certain criteria. 21 C.F.R. 1308.33(a) further states that the Administrator of the DEA may exempt from the application of all or any part of the federal Controlled Substances Act any compound, mixture, or preparation containing an anabolic steroid which is intended for administration to a human being or animal, if, because of its concentration, preparation, formulation, or delivery system, it has no significant potential for abuse. 21 C.F.R. 1308.34 establishes the list of anabolic steroid products which are exempt from all or part of the federal Controlled Substances Act.

††††† 4. Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate? This administrative regulation does not impose stricter requirements that those required by federal mandate.

††††† 5. Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements. Not applicable.