Category Archive: Compounding

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CVM Issues Guidance on Enforcement Policy Regarding the Compounding of Vet Drugs Using Bulk Drug Substances

By | November 19, 2019 | Compliance, Compounding, CVM, Regulatory Affairs | Like |

In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals.

Unlike the statute and regulations for human drugs, there are no provisions for compounding animal drugs using bulk drug substances.  

Vasopressin Verdict May be Precedent for Drug Companies Seeking to Protect Approved Products

By | October 1, 2019 | Compounders, Compounding, FDA, NDA, Regulatory Affairs | 1 |

In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community.  The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first approval through an NDA process. 

stack of one hundred dollars notes

FDA Announces MDUFA and Outsourcing User Fee Rates for FY 2020 – All Fees Higher

By | July 30, 2019 | Compounding, FDA, Medical Devices, Regulatory Affairs, User Fees | Like |

In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020.  The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020.

The medical device fees are provided in the charts below,

503A Compounders May Get Another Bulk Substance Permitted, But For Now, Enforcement Discretion

By | July 8, 2019 | Bulk Drugs List, Compounding, FDA | Like |

In a Federal Register Notice (here) published today, the FDA announced a Compliance Policy which will exercise enforcement discretion relative to 503A compounders using the bulk drug, Oxitriptan, for compounding oral forms of the drug.  Remember, “FDA issued a final rule (84 FR 4696) (“February 19, 2019, final rule”), which established the list of bulk drug substances that can be used to compound drug products under Section 503A of the FD&C Act even though they are not the subject of an applicable USP or NF monograph or a component of an FDA approved drug product (the 503A Bulks List).” Oxtriptan was specifically excluded from that list.

Could the Compounding Responsibility Move to CDER’s Office of Compliance Signal Increased Enforcement Priorities?

By | June 12, 2019 | Compounders, Compounding, FDA | Like |

We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.”  While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a tougher enforcement stance from the Agency.

Gottlieb’s Parting Message on Compounding – Priorities for 2019

By | April 4, 2019 | Compliance, Compounding, FDA, Regulatory Affairs | 1 |

As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs.  As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the public if not prepared properly. 

Compounder of Sterile Products Hit with Consent Decree

By | March 12, 2019 | Compliance, Compounding, FDA | Like |

A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas.  According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products.  “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.  

Capsules in mortar

Final Guidance on Bulk Drugs that Can Be Used for Compounding for 503B Outsourcing Facilities

By | March 1, 2019 | Compliance, Compounding, FDA, Regulatory Affairs | Like |

The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here).  After the posting of the draft guidance, the FDA says that it received approximately sixty comments from stakeholders and,

Happy Holidays from Us to You!

By | December 20, 2018 | ANDAs, Approvals, Bioequivalence, Biologics, Chemistry, Combination Products, Complex Generics, Compliance, Compounding, Data Integrity, Dietary Supplements, eCTD, FDA, FDA, Generics, Guidance, Manufacturing, NDA, News, OTC, Regulatory Affairs, Science & Technology, Shortages, Training, Uncategorized, User Fees, Validation | Like |

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

FDA Revises 503B cGMP Guidance for Outsourcing Compounders

By | December 10, 2018 | Compliance, Compounding, FDA | Like |

On Monday, the FDA revised the “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance” (here).  The initial draft guidance issued in 2014.

According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “[t]his revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.