EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb1099*
HOUSE BILL 1099
M4, J2 4lr1728
By: Delegate Guyton
Introduced and read first time: February 7, 2024
Assigned to: Environment and Transportation
A BILL ENTITLED
AN ACT concerning 1
Veterinary Practitioners and Veterinary Technicians – Compounding 2
Prescription Drugs – Authorization and Requirements 3
FOR the purpose of authorizing certain veterinary practitioners and veterinary technicians 4
to compound prescription drugs under certain circumstances; requiring a veterinary 5
clinic or hospital that carries out compounding to establish certain policies and keep 6
certain records regarding certain compounded prescription drugs; authorizing an 7
office manager or veterinary assistant to maintain certain records in a certain 8
manner and update certain policies under certain circumstances; requiring a 9
veterinary clinic or hospital that compounds drugs on–site to take certain actions for 10
purposes of quality assurance; prohibiting a veterinary practitioner or veterinary 11
technician from compounding a drug under certain circumstances; authorizing a 12
veterinary practitioner to purchase, store, and distribute certain compounded drugs 13
under certain circumstances; requiring the State Board of Veterinary Medical 14
Examiners to establish certain safety standards and guidelines; and generally 15
relating to the compounding of prescription drugs by veterinary practitioners and 16
veterinary technicians. 17
BY repealing and reenacting, without amendments, 18
Article – Agriculture 19
Section 2–301(a), (i), and (j) 20
Annotated Code of Maryland 21
(2016 Replacement Volume and 2023 Supplement) 22
BY adding to 23
Article – Agriculture 24
Section 2–313.4 25
Annotated Code of Maryland 26
(2016 Replacement Volume and 2023 Supplement) 27
2 HOUSE BILL 1099
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 1
That the Laws of Maryland read as follows: 2
Article – Agriculture 3
2–301. 4
(a) In this subtitle the following words have the meanings indicated. 5
(i) “Veterinary practitioner” means a licensed and registered veterinarian 6
engaged in the practice of veterinary medicine. 7
(j) “Veterinary technician” means a person who is registered with the Board as a 8
veterinary technician. 9
2–313.4. 10
(A) (1) IN THIS SECTION THE FOLLOWING WORDS HAVE THE MEANINGS 11
INDICATED. 12
(2) (I) “COMPOUNDING ” MEANS: 13
1. ALTERING THE DOSAGE F ORM OF A DRUG ; 14
2. ALTERING THE DELIVERY SYSTEM OF A DRUG ; 15
3. ALTERING THE STRENGTH OF A DRUG; 16
4. COMBINING INGREDIENTS OF DIFFERENT DRUGS ; OR 17
5. PREPARING A COMPOUNDE D DRUG PREPARATION 18
FROM CHEMICALS . 19
(II) “COMPOUNDING ” INCLUDES: 20
1. THE PREPARATION OF A COMPOUNDED DRUG FROM 21
BULK SUBSTANCES ; AND 22
2. THE PREPARATION OF OFFICE –USE PRODUCTS 23
APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION THAT HAVE BEEN 24
CREATED IN: 25
HOUSE BILL 1099 3
A. A PHARMACY EQUIPPED WI TH A CLASS A 1
PRESCRIPTION BALANCE AND WEIGHTS , OR A PRESCRIPTION BA LANCE WITH 2
EQUIVALENT OR SUPERI OR SENSITIVITY TO A CLASS A PRESCRIPTION BALANCE ; OR 3
B. AN OUTSOURC ING FACILITY REGISTE RED WITH THE 4
U.S. FOOD AND DRUG ADMINISTRATION . 5
(3) “OFFICE USE” MEANS PATIENT TREATM ENT CARRIED OUT BY A 6
VETERINARY PRACTITIO NER OR A VETERINARY TECHNICIAN UNDER THE DIRECT OR 7
INDIRECT SUPERVISION OF A VETERINARY PRAC TITIONER. 8
(4) “PATIENT TREATMENT” INCLUDES: 9
(I) TREATMENT PROVIDED DU RING A PATIENT ’S OFFICE OR 10
HOSPITAL VISIT; 11
(II) TREATMENT PROVIDED DU RING SURGERY ; 12
(III) EMERGENCY TREATMENT ; AND 13
(IV) PRESCRIBED AT–HOME TREATMENT . 14
(B) COMPOUNDING MAY BE CARRIED OUT BY: 15
(1) A VETERINARY PRACTITIO NER WHO HAS AN ESTAB LISHED 16
RELATIONSHIP WITH TH E CLIENT; OR 17
(2) A VETERINARY TECHNICIA N UNDER THE DIRECT S UPERVISION OF 18
A VETERINARY PRACTIT IONER WHO HAS AN ESTABLISH ED RELATIONSHIP WITH THE 19
CLIENT. 20
(C) A VETERINARY CLINIC OR HOSPITAL THAT CARRIE S OUT COMPOUNDING 21
SHALL: 22
(1) ESTABLISH POLICIES AN D CREATE A MANUAL ON COMPOUND ING 23
THAT INCLUDE : 24
(I) HOW EACH COMPOUNDED D RUG WAS CREATED , 25
INCLUDING: 26
1. THE MANUFACTURER ’S NAME; 27
2. THE ORIGINAL DOSAGE; 28 4 HOUSE BILL 1099
3. THE LOT NUMBER ; 1
4. THE EXPIRATION DATE ; AND 2
5. THE PURCHASE DATE ; AND 3
(II) HOW VETERINARY TECHNI CIANS SHALL BE TRAIN ED AT 4
COMPOUNDING ; 5
(2) MAINTAIN A RECORD OF : 6
(I) THE FORMULA USED WHEN COMPOUNDING ; 7
(II) ALL ACTIVE AND INACTIVE INGREDI ENTS; 8
(III) ANY EQUIPMENT USED ; 9
(IV) THE EXPIRATION DATE O F: 10
1. THE COMPOUNDED DRUG; AND 11
2. ANY INGREDIENTS USED ; 12
(V) THE SPECIFIC STEPS TA KEN WHILE COMPOUNDIN G; 13
(VI) INSTRUCTIONS ON PROPE R STORAGE , HANDLING, 14
ADMINISTRATION , AND DISPOSAL OF THE COMPOUNDED DRUG; AND 15
(VII) THE NAME OF THE INDIVIDUAL WHO PREPARED THE DRUG 16
AND THE DATE OF PREPARATION ; 17
(3) MAINTAIN THE FOLLOWING INFORMATIO N IN A PATIENT RECORD : 18
(I) THE NAME OF THE VETER INARY PRACTITIONER W HO 19
COMPOUNDED , OR SUPERVISED THE CO MPOUNDING OF , THE DRUG, AND THE NAME 20
OF THE VETERINARY TE CHNICIAN, IF APPLICABLE; 21
(II) THE EXPIRATION DATE O F THE COMPOUNDED DRU G; 22
(III) INSTRUCTIONS ON PROPE R STORAGE , HANDLING, 23
ADMINISTRATION , AND DISPOSAL OF THE COMPOUNDED DRUG ; 24
HOUSE BILL 1099 5
(IV) THE NAME , STRENGTH, AND QUANTITY OF THE 1
COMPOUNDED DRUG ; AND 2
(V) THE DATE THE DRUG WAS COMPOUNDED ; AND 3
(4) MAINTAIN PROPER STORA GE FOR COMPOUNDED DR UGS. 4
(D) AN OFFICE MANAGER OR VETERINARY ASSIST ANT, UNDER THE 5
SUPERVISION OF A VET ERINARY PRACTITIONER , MAY: 6
(1) MAINTAIN THE RECORDS REQUIRED UNDER SUBSE CTION (C) OF 7
THIS SECTION IN WRIT TEN OR ELECTRONIC FO RMAT; AND 8
(2) UPDATE THE POLICIES AND MAN UAL REQUIRED UNDER 9
SUBSECTION (C) OF THIS SECTION. 10
(E) A VETERINARY PRACTITIONER S HALL PROVIDE TRAINING FOR A 11
VETERINARY TECHNICIA N WHO IS COMPOUNDING DRUGS OR HANDLING 12
COMPOUNDED DRUGS UNDER THE SUPERVISIO N OF THE VETERINARY 13
PRACTITIONER . 14
(F) A VETERINARY CLINIC OR HOSPITAL THAT COMPOUNDS DRUGS ON–SITE 15
SHALL: 16
(1) CREATE A QUALITY ASSU RANCE PROGRAM THAT D OCUMENTS 17
AND ASSESSES MEDICAT ION ERRORS; 18
(2) DOCUMENT ANY CAUSES , REACTIONS, AND TREATMENTS 19
RESULTING FROM MEDIC ATION ERRORS ; 20
(3) CONTACT A CLIENT AS SOON AS POSSIBLE TO NOTIFY THE M OF 21
ANY ERRORS AND THE STEPS REQUIR ED TO FIX THE ERROR AND TO AVOID INJURY 22
OR ILLNESS; AND 23
(4) BE SUBJECT TO QUESTIO NS AND REVIEW FROM T HE BOARD AND 24
THE STATE BOARD OF PHARMACY. 25
(G) A VETERINARY PRACTITIO NER OR VETERINARY TECHNICIAN MAY NOT 26
COMPOUND A DRUG IF T HE COMPLEXITY OF COM POUNDING THE DRUG IS BEYOND 27
THE VETERINARY PRACT ITIONER’S OR VETERINARY TECHNI CIAN’S KNOWLEDGE , 28
SKILL, EXPERTISE, OR AVAILABLE FACILIT IES OR EQUIPMENT . 29
6 HOUSE BILL 1099
(H) A VETERINARY PRACTITIO NER MAY PURCHASE COMPOUN DED DRUGS 1
FOR OFFICE USE IF TH E DRUGS WERE COMPOUN DED AT A LICENSED PH ARMACY IN 2
THE STATE OR AT AN OUTSOU RCING FACILITY. 3
(I) A VETERINARY PRACTITIO NER MAY STORE COMPOU NDED DRUGS FOR 4
IN–OFFICE OR HOSPITAL USE: 5
(1) IF COMPOUNDED AT A LICENSED PHARMACY IN THE STATE OR AT 6
AN OUTSOURCING FACIL ITY, FOR A PERIOD OF 21 DAYS; AND 7
(2) IF COMPOUNDED IN THE VETERINARY PRACTITIO NER’S OFFICE 8
OR HOSPITAL, FOR A PERIOD OF 14 DAYS. 9
(J) A VETERINARY PRACTITIO NER MAY DISPENSE COM POUNDED DRUGS 10
IN–OFFICE: 11
(1) FOR IMMEDIATE MEDICAL NEED; 12
(2) WHEN THERE ARE LIMITE D OR NO RETAIL OPTIO NS AVAILABLE 13
TO THE PATIENT; AND 14
(3) WHEN THERE IS A POTEN TIAL RISK OF HARM TO THE PATIENT IF 15
THE COMPOUNDED DRUGS ARE NOT DISPENSED . 16
(K) THE BOARD SHALL EST ABLISH STANDARDS AND GUIDELINES FOR 17
VETERINARY PRACTITIO NERS AND VETERINARY TECHNICIANS TO ENSURE THE 18
SAFETY OF COMPOUNDED DRUGS. 19
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 20
October 1, 2024. 21