Prescriber's Agreement

PHARMACY REQUIREMENTS

The compounding of preparations will include the following activities by the Pharmacy: verification of the source of raw materials to be used; compliance with applicable United States Pharmacopoeia guidelines (including testing requirements), the Health Insurance Portability and Accountability Act of 1996, and all applicable competency and accrediting standards as determined by the Ohio State Board of Pharmacy as well as the Board of Pharmacy in the Practice's state residence. Pharmacy agrees to record the lot numbers of compounded preparation supplied for office administration so that, in the event a recall of the preparation is required, Pharmacy shall notify Physician of the recall and can facilitate contacting any patients who received the product. In such an event, Pharmacy’s existing protocols for notifying patients, quarantine of the product (if applicable), and/or recall will be followed.

Any adverse reactions or complaints may be submitted by the patient to either Pharmacy or Physician; in the event a report is made, the entity receiving
the report will forward a copy to the other entity. If patient harm is suspected or confirmed to be due to a preparation compounded by Pharmacy, Pharmacy will notify the Ohio State Board of Pharmacy, the Board of Pharmacy where the patient resides, and the FDA.

Lee Silsby Compounding Pharmacy is a licensed 503A compounding pharmacy. The following provisions are required - 

• Compounding must be based on the receipt of a valid prescription for an identified individual patient. It can occur after the receipt of the prescription, or in limited quantities before the receipt of such a prescription.

PRESCRIBER REQUIREMENTS

1. These compounded preparations may only be administered to the patient for which the medication was prescribed, and may not be sold to any other. These compounded preparations may only be administered to the patient for which the medication was prescribed, and may not be sold to any other person or entity. When the compounded preparation is administered, physician agrees to indicate on the patient’s medical chart the lot number and beyond-use date (BUD) of the preparation used. The drugs may only be administered by an individual authorized by law to administer the drugs.

2. Physician is licensed in the same state as Practice.

3. Prescribers must acknowledge a patient assessment and diagnosis is required prior to initiating a pre-printed order in accordance with the prescriber's scope of practice, in accordance with OAC 4729:5-3-12.

4. If Physician terminates relationship with Practice, Physician will immediately notify Pharmacy the date of termination.

5. Please note that per OAC 4729:5-5-12(B)(2) , a prescriber's practice location is required for outpatient prescriptions:

(2) Contain the manually printed, typewritten, or preprinted full name, professional title, and address of the prescriber. The prescriber's address shall include the physical address of the prescriber's practice location.

6. Prescribers must acknowledge the requirement to document - (1) patient assessment, (2) diagnosis and (3) the drugs shall be administered by an individual authorized by law to administer the drugs:

Defined in Ohio Administrative Code Rules -  4729:5-3-12 Protocols and pre-printed orders for medication administration and 4729:5-3-12 Protocols and pre-printed orders for medication administration.

California Prescribers Only

Summary 
The California Board of Pharmacy has continued to prosecute pending enforcement
actions against pharmacies that compound sterile preparations using bulk drug
substances that do not have USP/NF drug monographs. This includes compounding with Glutathione and Methylcobalamin – bulk drug substances that appear on FDA’s 503A Category 1 list, but they do not possess a USP/NF drug monograph.

Our clinical pharmacists recommend the following commercially available products instead of Compounded Glutathione or Methylcobalamin:

N- Acetylcysteine 7mg/mL Injection (Commercially product available for
purchase at Lee Silsby)
Hydroxocobalamin 1,000 mcg/mL Injection (Commercially product available for purchase at Lee Silsby)

By signing this agreement, you are acknowledging that

(A) diverting Methylcobalamin or Glutathione is against California Board of Pharmacy rules and regulation and

(B) Lee Silsby Compounding Pharmacy has the right to discharge your practice without notice if it is suspected that you are sending compounded Glutathione and Methylcobalamin directly or indirectly to patients in California.

CONTROLLED SUBSTANCE REQUIREMENTS

The State, Medical, and Pharmacy Board requirements located in your state, as well as the Drug Enforcement Agency (DEA), regulate the legal requirements for generating prescriptions for a legitimate medical purpose. DEA rules also explicitly define the use of agents to help facilitate the transmission of controlled substance prescription orders. The summary of the DEA rule is noted below, and the language in that rule serves as the foundation for terms of using our e-prescription portal.

For a prescription for a controlled substance to be effective, the prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice. This determination is the sole responsibility of the practitioner and may not be delegated. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

A prescription may be prepared by the secretary or agent for the signature of a practitioner. Accordingly, an authorized agent may prepare a controlled substance prescription only based on the instructions of the prescribing practitioner as to the required elements of a valid prescription and then provide the prescription to the practitioner to review. The authorized agent does not have the authority to make medical determinations. For a controlled substance, the practitioner must personally sign the prescription, whether manually or electronically. The prescribing practitioner cannot delegate his or her signature authority. 21 CFR 1306.05(f)

As noted above, the practitioner remains responsible for ensuring that the prescription conforms to State and Federal Laws and Regulations, and the practitioner cannot delegate to an agent the authority to make a medical determination of need for a controlled substance prescription. However, the prescriber may delegate the transmission of the prescription drug order to an authorized agent.

REQUIRED SIGNATURE BY A LICENSED PRACTITIONER

By signing this form, l declare under penalty of perjury (under the laws of the United States of America) that I am a licensed practitioner with prescriptive authority. I also agree that this agent authority agreement may be electronically signed only by licensed prescribers that are in good standing with their overseeing state and federal agencies. I agree that the electronic signatures appearing on this agreement are the same as handwritten signatures for the purposes of validity, enforceability and admissibility. Specifically, any false or misleading e-signatures will carry the same level of criminal prosecution as forgery using handwritten signatures.