The organization of the Guidance is as follows:

1. INTRODUCTION AND SCOPE
   
   
2. BACKGROUND
   1. Section 503B of the FD&C Act
   2. Compounding, Generally
   3. Compounding Drugs From Bulk Drug Substances
   4. Process for Developing the 503B Bulks List
      
      
3. POLICY
   1. Bulk Drug Substance for Which There Is a Clinical Need
   2. Analysis for Evaluating Nominated Bulk Drug Substances

Due to the length of this document, only a summary will be provided here of the highlighted portion above, and readers are encouraged to read the document in its entirety at:

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/
guidances/ucm602276.pdf

• The purpose of this Guidance is to provide FDA's policy for evaluating bulk drug substances nominated for use in compounding by OUTSOURCING FACILITIES registered under section 503B.
  
  
• Two requirements for compounding using bulk drug substances:
  • Clinical need
  • Appearance on drug shortage list
    
    
• Compounding using FDA-approved drug products instead of a bulk drug substance would meet patients' medical needs and present less risk.

A. Bulk Drug Substance for Which There Is a Clinical Need

• There must be a clinical need.
• It requires compounding using the bulk drug substance.
• Supply issues/back orders are not considered as a clinical need (drug shortage list is not included here).
• Use of bulk drug substance may be limited to specific strengths, routes of administration, or dosage forms.
• Only the particular salt or ester appearing on the 503B Bulks List can be used.
• Inclusion of a substance on the 503B Bulks List does not equate with or be considered an FDA approval, endorsement, or recommendation of any drug product compounded using the substance. If represented as such, it will cause the drug to be misbranded.

B. Analysis for Evaluating Nominated Bulk Drug Substances

• Two Part Evaluation:
  • Part I: Is the bulk drug substance a component of an FDA-approved product?
  • Part II: Is the substance clinically necessary?
• Is there a basis to conclude that the use of the FDA-approved drug product makes it medically unsuitable to treat certain patients?
• Is there a basis to conclude that the drug product proposed to be compounded must be produced from a bulk drug substance rather than from an FDA-approved drug product?
• If the answer is "yes" to the previous two questions, a "balancing test" will be considered, including the following factors:
  • The physical and chemical characterization of the substance,
  • Any safety issues raised by the use of the substance in compounding,
  • The available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists, and
  • Current and historical use of the substance in compounded drug products, including information about the medical condition(s) that the substance has been used to treat and any references in peer-reviewed medical literature.
• Historical and current use in compounding will be considered. The longer a substance has been used in compounding and the broader its use, particularly to compounding drug products for office stock, the more this factor will generally weigh in favor of inclusion of the substance on the Bulks List.

The 17-page Guidance is quite detailed and oftentimes confusing. The above is simply a summary. If depending upon this Guidance in your facility or for nominating drug substances for inclusion on the Bulks List, it must be read in its entirety.

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

The Joint Commission Deletes Two Requirements for Hazardous Drugs
The Joint Commission (TJC) has announced the deletion of two Elements of Performance (EPs) from their "Compounding Sterile and Nonsterile Preparations" (MDCSN) chapter in the Medication Compounding Certification Program. The deletions were effective as of March 9, 2018.

TJC is deleting two EPs from the "Medication Compounding" (MC) chapter in the Home Care Accreditation Program. These deletions were also effective March 9, 2018. The deleted EPs are related to environmental surface sampling for the residual hazardous medication compounding processes.

Sources:

• Prepublication Standards - Deletion of Requirements Related to Medication Compounding, Medication Compounding Certificate Program
• Prepublication Standards - Deletion of Requirements Related to Medication Compounding, Home Care

New FDA Drug Shortages Update

• Amino Acids (Updated - Currently in Shortage)
• Atenolol Tablets (Updated - Currently in Shortage)
• Diclofenac Sodium Extended Release Tablets (New Discontinuation)
• Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
• Potassium Chloride Injection (Updated - Currently in Shortage)
• Sodium Chloride 0.,0% Injection Bags (Updated - Currently in Shortage)
• Sterile Water (Updated - Currently in Shortage)

For a complete drug shortage list, go to the FDA website at: www.fda.gov.

Did You Know ...

�that Will Rogers made the following statement?

"Never miss a good chance to shut up!"

Tip of the Week

Along with the above quote by Will Rogers, one thinks of:

• "Silence is Golden" (Maybe that's why there is so little of it!)
• Most people agree with the person that keeps their mouth shut.
• There are two occasions especially when one should keep his mouth shut-when swimming underwater and when angry!
• Half the world consists of people who have something to say and don't; the other half have nothing to say and keep on saying it!
• Silence-what would follow if the average politician spoke their mind.

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Looking Back

The draftee tried a tube
And purred,
Well whaddya know,
I've been defurred!
     Burma Shave