4729-9-21 Drugs compounded in a pharmacy.

 

 

 

TO BE RESCINDED

 

4729-9-21                    Drugs compounded in a pharmacy.

 

 

 

(A)   In order to compound prescriptions, a pharmacy shall meet the minimum standards for a pharmacy pursuant to rule 4729-9-02 of the Administrative Code.

 

(B)   Parenteral and sterile product prescriptions shall be compounded in accordance with Chapter 4729-19 and/or Chapter 4729-15 of the Administrative Code.

 

(C)  For all compounded prescriptions, the pharmacist shall:

 

(1)   Comply with the "United States Pharmacopeial Convention Chapter 795" when compounding non-sterile drug products;

 

(2)   Comply with the "United States Pharmacopeial Convention Chapter 797" when compounding sterile compounded drug products;

 

(3)     Comply  with  section  503A  of  the  Federal  Food,  Drug,  and  Cosmetic  Act (11/27/2013).

 

(4)   Inspect and approve the compounding process;

 

(5)   Perform the final check of the finished product.

 

(D)  For all compounded prescriptions, the pharmacist shall be responsible for:

 

(1)  All compounding records;

 

(2)      The  proper  maintenance,  cleanliness,  and  use  of  all  equipment  used  in compounding.

 

(E)   Personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the operation being performed. Protective apparel shall be worn as necessary to protect personnel from chemical exposure and drug products from contamination.

 

(F)   A prescription shall be compounded and dispensed only pursuant to a specific order for an individual patient issued by a prescriber. A limited quantity may be compounded in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

 

(G)   A compounded prescription that is dispensed to a patient must be labeled according

 

 

to rule 4729-5-16 of the Administrative Code.

(H)      Labels  for  a  compounded  prescription  that  is  prepared  in  anticipation  of  a prescription drug order shall contain, but not be limited to, the following:

(1)     The  name,  strength,  and  quantity  of  each  drug  used  in  the  compounded prescription;

(2)   The identification of the repackager by name or by the final seven digits of its terminal distributor of dangerous drugs license number;

(3)   Pharmacy control number;

(4)   The pharmacy's expiration date or beyond use date.

Effective:	04/28/2016
Five Year Review (FYR) Dates:	01/21/2016
CERTIFIED ELECTRONICALLY
Certification
04/18/2016
Date
Promulgated Under:	119.03
Statutory Authority:	3715.69 , 3719.28 , 4729.26
Rule Amplifies:	3715.521 , 3715.63 , 3715.64 , 3719.05 , 4729.28 ,
	4729.55
Prior Effective Dates:	7/1/1994, 3/1/1999, 2/1/2005, 1/1/09, 01/01/2015