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		U.S. Food and Drug Administration Compliance Policy Guidelines

The following is a tabular summary of the Guidance for Industry, "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act".

CATEGORY	FDA POLICY
The bulk drug substance appears in 503A Category 1 on FDA's website at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/PharmacyCompounding/UC M467373.pdf. Such substances may be eligible for inclusion on the 503A bulks list, were nominated with sufficient supporting information for FDA to evaluate them, and do not appear to present a significant safety risk.	FDA does not intend to take action for compounding a drug product from a bulk drug substance in Category 1 that does not meet the conditions of section 503A(b)(1)(A)(i), provided that the bulk drug substance was manufactured by an establishment registered with FDA under section 510 of the FD&C Act and is accompanied by a valid COA from the entity that originally produced the bulk drug substance and provided that the drug compounded from the bulk drug substance is compounded in compliance with the other conditions of section 503A.
The bulk drug substance is a component of an FDA-approved drug and/or the subject of an applicable USP or NF monograph.	The bulk drug substance can be used in compounding under section 503A of the FD&C Act, provided it complies with the standards of the monograph (if one exists) and is compounded in compliance with the other conditions of section 503A.
The bulk drug substance appears on the withdrawn or removed list.	The bulk drug substance cannot be used in compounding under section 503A of the FD&C Act. A drug compounded using the bulk drug substance is subject to regulatory action.
The bulk drug substance appears in 503A Category 2 on FDA's website at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/PharmacyCompounding/UC M467373.pdf. The substance has been identified by FDA as presenting a significant safety risk.	The bulk drug substance cannot be used in compounding under section 503A of the FD&C Act unless and until FDA publishes a final rule authorizing its use under section 503A.
The bulk drug substance is a biological product subject to approval in a BLA.	The substance is not eligible for the 503A bulks list. FDA has issued a separate draft guidance document describing the Agency's proposed policies concerning mixing, diluting, and repackaging biological products subject to approval in a BLA.²²
The bulk drug substance appears in 503A Category 3 on FDA's website at http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/PharmacyCompounding/UC M467373.pdf. The substance may be eligible for inclusion on the 503A bulks list, but was nominated with insufficient supporting information for FDA to evaluate it.	The bulk drug substance cannot be used in compounding under section 503A of the FD&C Act., See section III.B of this guidance for information about re-nominating substances that were previously nominated with insufficient supporting information.

²²See FDA's draft guidance, Mixing, Diluting, and Repackaging Biological Products Subject to Approval in a Biologics License Application.

Next week, we will begin looking at the DRAFT Guidances that are out for comment.

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

Express Scripts Putting Burden on Pharmacies in the Antitrust Suit
Express Scripts has petitioned a federal court to force compounding pharmacists to materially substantiate their claims. The pharmacies behind the legal challenge accuse the PBM of:

implementing prior authorizations on prescriptions,
rejecting most of them, and
then diverting customers to other compounding facilities where it is financially vested.

The complaint states that the PBMs' actions breached state and federal antitrust laws, costing the specialty pharmacies more than $100 million. Express Scripts has requested:

tax returns,
information on copayment policies and claims reimbursement, and
other documentation

from the pharmacies to help it determine if the case has any merit or if the pharmacies somehow acted improperly.

The compounding pharmacies have resisted on the grounds that the request is premature and that attorney-client privilege applies.

Express Scripts counters that the request is not out of line, considering that fact discovery ends December 1, and insists it has the right to know the basis of the lawsuit.
https://www.law360.com/articles/857964?sidebar=true

Topical Analgesics Decreases Use of Other Pain Medications
Patients treated for at least five months with topical analgesics used less oral medication, including opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and over-the-counter (OTC) agents. (PAINWeek 2016 , Abstract 47). The OPERA (Optimizing Patient Experience and Response to Topical Analgesics) study wanted to determine whether there were any differences between topical analgesics and other types of available treatments.

A brief summary of the study shows that after three months on topical therapy, patients experienced reduced use of opioids (27.5%), NSAIDs (64.1%), and OTC analgesics (51.4%). After at least five months with the topical therapy, the reductions were more pronounced: 41.5% for opioids, 70.9% in those taking NSAIDs (70.9%), and 51.6% for OTC analgesics.
http://www.painmedicinenews.com/Clinical-Pain-Medicine/Article/11-16/Topical-Analgesics-Result-in-Decreased-Use-of-Other-Pain-Medications/38446

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Did You Know ...

ï¿½that at the FDA Pharmacy Compounding Advisory Committee meeting last week, the following voting actions were voted on as recommendations to the FDA? They are not final.

Bulk Substances List

Diindolylmethane		8-1 to NOT place on the list
Glycolic acid		8-0 to ADD it to the list
Kojic acid		3-4-1 to NOT place on the list
Trichloracetic acid		7-1 to ADD it to the list
Vasoactive Intestinal Peptide		8-0 to NOT place on the list

Demonstrably Difficult to Compound List
Transdermal Delivery Systems ADDED (Note: These are the patches.)

Tip of the Week

All compounding pharmacists should follow the activities of the Pharmacy Compounding Advisory Committee by either keeping up-to-date on the IACP website or going direct to the FDA.org website. Just a comment, it is far easier to use the IACP website for news as the FDA website is not as well organized and is sometimes difficult to navigate.

Looking Back

My cheek, says she,
Feels smooth as satin,
Ha! Ha! Says he,
That's mine you're pattin'!
Burma Shave


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