January 20, 2017 — The Food and Drug Administration (FDA) recently issued a Guidance concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act (the “Act”).  The Guidance does not set forth any legal responsibilities.  Rather, the FDA describes how the agency plans to implement and interpret the prescription requirement. Some of the more important parts of the Guidance are highlighted below.

Section 503A describes certain circumstances under which drugs compounded for human use by a licensed pharmacist in a State licensed pharmacy or Federal facility, or a licensed physician will be exempt from other sections of the Act, specifically (a) section 501(a)(2)(B) – concerning current good manufacturing practice or CGMP requirements, (b) section 502(f)(1) – concerning the labeling of drugs with adequate directions for use and (c) section 505 – concerning the approval of drugs under new drug applications or abbreviated new drug applications (NDAs or ANDAs, respectively).

The Guidance notes that while compounded drugs often serve important medical needs, they present a number of risks to patients not associated with FDA-approved drugs, including the fact that they have not undergone an FDA premarket review for safety, effectiveness, and quality, and the greater risk of contamination during the compounding process. Due to these and other risks, the FDA places conditions on compounding that must be met for compounded drugs to qualify for the exemptions in section 503A. Those conditions include:

  • Compounding is for an identified individual patient;
  • The drug must be compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or by a licensed physician;
  • Drugs compounded in advance of receiving prescriptions are compounded only in limited quantities; and
  • Drugs are distributed pursuant to a valid patient-specific prescription.

Valid Patient-Specific Prescription

As set forth in the Guidance, a valid prescription order for a compounded drug is

  • A prescription that identifies the patient for whom the drug has been prescribed AND
  • Is issued from a licensed physician or other licensed practitioner authorized by state law to prescribe drugs (“prescriber”); or
  • Is set out in an order or notation made by a prescriber in a patient’s health record or chart in an inpatient setting; or
  • Is set out in an order or notation by a physician who compounds a drug for his or her own patient documented in that patient’s health record.

When a Drug Can Be Compounded Under Section 503A

A drug can be compounded after receipt of a valid prescription order OR, in more circumscribed circumstances, BEFORE receipt of a valid prescription order. Those circumstances are described as follows:

  • Except as described below, in order to qualify for the exemptions under section 503A, the drug product must be compounded after the licensed pharmacist or licensed physician receives a valid prescription order for an individual patient.
  • A drug may be compounded before the receipt of a valid prescription order (“anticipatory compounding”) for an individual patient IF all of the conditions of section 503A are met, including:
    • The compounding is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the human drug product; and
    • The orders have been generated solely within an established relationship between the licensed pharmacist or licensed physician and either such patient for whom the prescription order will be provided or the physician or other licensed practitioner who will write such prescription order.

Quantity of Drug Compounded

A drug that falls under the category of “anticipatory compounding” may only be produced in limited quantities. Per the guidance, the FDA indicates that it will not consider whether a compounder has exceeded the limited quantity condition under 503A if:

  • The compounder holds for distribution no more than a 30-day supply of a particular compounded drug product to fill valid prescriptions it has not yet received; and
  • The amount of the supply of a particular compounded product is based on the number of valid prescriptions that the compounder has received for identified individual patients in a 30-day period over the past year that the compounder selected.

The FDA guidance document is a key guidepost for entities compounding for human use under Section 503A of the Act. The FisherBroyles Pharmacy and Health Care Law team is well versed in these matters and welcomes your questions. Please contact any one of the following attorneys:

 

Amy Butler, FisherBroyles Partner
Amy Butler
amy.butler@fisherbroyles.legal
419.340.8466
Cleveland (Toledo Branch), Chicago, Detroit Offices

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci
Anthony.calaunci@fisherbroyles.legal
419.376.1776
Cleveland (Toledo Branch), Chicago, Detroit and New York Offices

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson
brian.dickerson@fisherbroyles.legal
202.570.0248
Naples and Washington D.C. Offices

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid
nicole.waid@fisherbroyles.legal
202.906.9572
Naples and Washington D.C. Offices

Katy Wane, FisherBroyles Partner
Katy Wane
Katy.wane@fisherbroyles.legal
502-890-5920
Cincinnati Office