FDA's Most Recent Guidance: Prescription Requirements Under Section 503A

On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses:

• Compounding after the receipt of a prescription for an identified individual patient,
• Compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding) and
• Compounding for “office use”

The Prescription Guidance notes that a valid prescription order for a compounded product must be received from a licensed physician or other licensed practitioner authorized by state law to prescribe drugs before dispensing a compounded drug.

In addition, the policy notes that a pharmacist may consult with the prescriber to determine whether the patient needs a compounded drug and make appropriate notations on the prescription order. Such notations, which would serve as the basis for compounding under Section 503A, must include the prescriber’s determination that a compounded drug is necessary for the identified patient.

The FDA recommends using the following statement:

“Per [type of communication] with [name of prescriber] on [date], [name of prescriber] has advised that compounded [name of drug] for the treatment of [name of patient].”

The Prescription Guidance does recognize the statutory authority to engage in “anticipatory compounding,” or the practice of compounding drugs in advance of receiving a valid prescription order based on the historical needs and relationship between a licensed pharmacist and the prescriber.

However, FDA notes that the “limited quantity” restriction regarding anticipatory compounding would likely be interpreted as a limit of a 30-day supply based on the relationship.

Finally, the Prescription Guidance addresses office use, or the practice of shipping compounded drugs to hospitals, clinics and physician offices in advance or without first obtaining a prescription for an individual patient.

The FDA acknowledges that hospitals, clinics and health care practitioners have valid needs for office stock and office use compounded drug products to administer to patients who present with an immediate need for a compounded drug product. However, the the FDA notes that such compounded products can be obtained from FDA outsourcing facilities registered under Section 503B or via anticipatory compounding in a limited quantity provided a patient-specific prescription order is presented for the compounded drug product.

Up next: Analysis on the third FDA draft guidance which clarifies the definition of “Facility” under Section 503B.