Question

STUDY SCENARIO AND QUESTIONS Compoundit Pharmacy is near a clinic with three dermatologists, and as a result receives several prescrip tions a week for various topical prescription ointments, creams, and gels. Most of the ointments, creams, and gels are available commercially, but Compoundit prefers to compound them because of the greater profits. Compoundit makes about a week's supply of the various topical drugs at a time. Other pharmacies in the area also get prescriptions for these topicals but dispense the commercially made products. Compoundit approached these pharmacies, offering to make and sell them the topicals at a lower price than they pay from the manufacturers. The pharmacies agreed to purchase the products from Compoundit. The FDA and board of pharmacy launch an investigation of Compoundit. 1. Analyze and discuss each of the activities presented in this scenario and whether each activity consti tutes compounding or manufacturing 2. Would Compoundit be on more firm legal grounds if it registered as an "outsourcing facility?"

Answer 1

Food and Drug Administration(FDA) investigator made inspection in facility.. inspection was conducted after receipt of a medwatch report..During the inspection,the investigators noted that drug products are failed to meet their conditions of section 503A of the federal food,Drug, and cosmetic Art(FDCA)..in addition,the FDA investigators noted serious deficiencies in your practices for producing non_sterile drug products which lead patient at risk..FDA also look for all unexpired lots of compounded drug products.. section 503A of the FDCA which human drug products compounded by a licensed pharmacy or a federal facility or licensed physician,with 3 quality reason like1,compliance with current good manufacturing practice(CGMP)2,labelling with adequate direction for use and FDA approval prior to marketing of the FDCA 3,receipt of valid prescription for individually _identified patients and bulk drug substance used to compound it should be 1,comply with the standards of US pharmacopeia 2,if such standards does not exists and be components of drugs approved by the secretary 3, if such a standards not exists drug substance is not a components of a drug approved by the secretary,developed by regulations..it is not compound a drug product have been withdrawn or removed from the market.. because it was unsafe or not effective..

2,compound it legal grounds in outsourcing facility:

In traditional components,outsourcing facilities satisfying legal requirements,compound and distribute drug without receiving prescription for individually identified patients and over quantity of drugs ship to investigate..

A,statutory framework:

Under section 503B FDA defines an outsourcing facilities to address to sterile drug,has elected to register as an outsourcing facikfac,w with all requirements of section 503B,labelling with adequate direction of use,new drug approval requirements,drug supply chain security..

B,profile of outsourcing facilities:

Many compound of sterile and non_sterlie drugs for both human and animals..FDA approval Drug,mixing,diluting and repackaging of biological products and drugs..

Operations:

It must be engage with sterile human drugs.. entities that do not compound sterile human drugs should not register as out sourcing facilities..

FDA inspection:

Under FDA inspection outsourcing facilities will be determined.. new outsourcing facilities within two months it should be inspected..it need CGMP requirements and the condition of section 503B..By observation FDA will decide this facilities to be closed or need further action..

Post inspection:

Forms FDA_483 are issued to firm management on inspection when an investigators has observed any conditions that in their judgement may violation of the FD&C Act and regulations..if outsourcing facilities have objection over observation FDA 483 form violation cited in a warning letter.. information submitted to FDA should be sufficient for the agency to determine proposed corrective action id adequate..