A Short Law Summary: Written Agreements for office use of Compounded Preparations

Three such states that provide written agreements or contracts  for office use of compounded preparations are Florida, Oklahoma and Texas.  The language of each law is very similar.  Be sure to check your state law to make sure you are in compliance.

Florida

Florida revised its limited in-office use exception where it only applies to patient-specific compounding. See Fla. Admin. Code R. 64B16-27.700(3). This amendment became effective  March, 21, 2013. As modified, the exception now requires the compounding pharmacy and the practitioner must enter into a written agreement which provides:

• The compounded drug may only be administered to the patient listed in the prescription, and may not be dispensed to the patient or sold to anyone else
• The practitioner must record on the patient’s chart the lot number and beyond-use date of the compounded drug
• The practitioner must provide the patient with a means to report complaints or adverse reactions to facilitate recalls.

See Fla. Adm. Code R. 64B16-27.700.

Oklahoma

In Oklahoma,  the applicable section of the administrative code is codified in the Oklahoma Statutes and provides:

(d) A retail pharmacy that provides compounded preparations to practitioners for office use
or to an institutional pharmacy shall enter into a written agreement with the practitioner or
pharmacy.  The written agreement shall:
(1) Address acceptable standards of practice for each party entering into agreement
and include a statement that the compounded preparation may only be administered
to the patient and may not be dispensed to the patient or sold to any other person or
entity
(2) Include liability language, references to performance improvement and quality
controls
(3)  require the practitioner or receiving pharmacy to include on patient’s record,
medication order, or medication administration record the batch number and BUD of
the compounded preparation administered to a patient
(4) Describe the scope of services to be performed by the filling pharmacy and
practitioner or receiving pharmacy, including a statement of the process for:
(A) A patient to report an adverse reaction or submit a complaint; and
(B) The pharmacy to recall compounded preparations.

535 O.S. § 15-10-64(d)(1)-(4).




Texas

In Texas, the administrative code provides:


(2) Written Agreement. A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall:
(A) address acceptable standards of practice for a compounding pharmacy and a practitioner and receiving pharmacy that enter into the agreement including a statement that the compounded drugs may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except as authorized by §563.054 of the Act;
(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient;
(C) describe the scope of services to be performed by the pharmacy and practitioner or receiving pharmacy, including a statement of the process for:
(i) a patient to report an adverse reaction or submit a complaint; and
(ii) the pharmacy to recall batches of compounded preparations.

Tex. Adm. Code R.   §291.133