Please note that these Draft Guidances are NOT FINALIZED; when they become finalized, they will represent the current thinking of the FDA on the specific topics.

Summary:

This Guidance 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

Organization:

1. Introduction and Scope
2. Background
   1. Overview
   2. The Prescription Requirement (Section 503A(a)
3. Policy
   1. Receipt of a Valid Prescription Order or a Notation Approved by the Prescriber Under Section 503A.
      • A valid prescription order for a compounded drug product means a valid prescription order from a licensed physician or other licensed practitioner authorized by state law to prescribe drugs.
      • It also includes a valid order or notation written by a prescriber in a patient's chart.
      • A prescription must identify the patient for whom the drug has been prescribed.
   2. When a Drug Can Be Compounded Under Section 503A
      • Generally, the drug must be compounded after receiving a specific prescription.
      • Compounding can be done prior to receiving a prescription IF it is done in limited quantities and is based on a history of receiving valid prescription orders for the compounded product.
      • No more than a 30-day supply of a particular compounded drug product is considered reasonable and is based on the number of valid prescriptions received.
   3. When a Compounded Drug Product Can Be Distributed Under Section 503A
   4. Office Stock/Office Use
      • Hospitals, clinics, and healthcare practitioners can obtain non-patient-specific compounded drug products from outsourcing facilities registered under section 5034B.
      • Outsourcing facilities can compound and distribute sterile and non-sterile non-patient-specific drug products to hospitals, clinics, and healthcare practitioners for office use. An entity that only compounds non-sterile drugs does not meet the definition of an outsourcing facility.
   5. Recordkeeping

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Checking Orders is Not Dispensing
A Massachusetts federal judge recently dismissed criminal charges against two NECC pharmacists who were not directly involved in the compounding process. The indictment alleged that they "dispensed drugs in interstate commerce without a valid prescription." The pharmacists worked in the packing area checking orders prior to shipment to NECC's customers. The government alleged the pharmacists "should have known from the improbable names of some of the patients whose addresses they were presumably checking (which included celebrities, star athletes, and fictional characters) that no medical practitioner had issued a valid prescription.

The court focused on the issue of whether checking orders meets the definition of "dispense." The term "dispense" is undefined in the FD&C Act, and the pharmacists argued that the court should determine the statute to be unconstitutionally void for vagueness in the absence of a definition. The judge analyzed the case in this way:

"Here, the issue is not ambiguity. The statute as written clearly punishes pharmacists who fill or take part in the filling of invalid prescriptions placed into interstate commerce with the intent to defraud or mislead the government. What the [FD&C Act] does not reach is conduct incidental to the distribution of a prescribed drug, such as 'checking a package,' or taking it to the extreme picking it up for delivery. Returning to the basics, the issue in this case is one of fair notice. Would a reasonable person, even a reasonable pharmacist, understand from the indictment that by matching orders to packages prior to their being shipped, she was criminally liable for participating in the filling of a prescription that she had never approved (or is even alleged to have seen), and as a result was guilty of dispensing (misbranding) the prescribed drug with the intent to defraud? The answer, as best as I can determine, is that she would not. Absent allegations of conduct amounting to fair notice of a crime under the [FD&C Act], the indictment fails."

The judged dismissed the criminal indictment against the two pharmacists.
http://www.pharmacytoday.org/article/S1042-0991(16)31404-9/fulltext

VA Expanding Scope of Nurse Practice
The Veteran Affairs Department has finalized a rule that will allow advanced-practice registered nurses to practice to their full authority at VA facilities. This new permission will not extend to certified registered nurse anesthetists. The change has long been opposed by the AMA, which immediately criticized the rule. About half of the states have full scope of practice laws for nurse practitioners. The purpose of the rule is to make it easier for veterans to be seen by medical professionals by increasing the number of available primary-care providers. The new policy is effective January 14, 2017. http://www.modernhealthcare.com/article/20161213/NEWS/161219974

Another Compounded Drug (DHEA Vaginal Insert) Approved by FDA
The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse, a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA).
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm529641.htm

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Did You Know ...

�that we hear a lot about translational science or translational research today, and it sounds quite complex, new, and intriguing. But, what is the relationship between translational science and applied science?

Tip of the Week

Translational science/research is, very generally speaking, "applied" science/research. Some state that translational research is increasingly a separate research field. It applies findings from basic science to enhance human health and well-being. It aims to "translate" findings in fundamental research into medical practice and meaningful health outcomes. It basically implements a "bench-to-bedside" model harnessing knowledge from basic sciences to produce new drug devices, and treatment options for patients.

Looking Back

His cheek was rough,
His chick vamoosed,
And now she won't,
Come home to roost!
     Burma Shave