Feedback for Seeking Feedback on Non-Sterile Compounding Standards

Pharmacist  ·  Nov. 1, 2016

Feedback on Model Standards for Pharmacy Compounding of Non-Sterile Preparations Draft 5b- August 5, 2016

Background- worked in pediatric hospital for 20 years. Have completed PCCA compounding course. Currently drug information pharmacist responsible for compliance with accreditation standards.

Page 8 – typo – second last paragraph – extra , However, ,

Page 9 & Page 11 – reference to CF – Canadian Formulary – appears that this document was used in the 1930’s . As a graduate from 1980s, have never used this document and would presume that the standards set forth in the document are very outdated. Would remove reference to this document.

Page 11 – USP 795 simple insert – would remove the example of captopril oral solution. Captopril oral solution has lead to therapeutic failures at our institution because some formulations for this product do not pH adjust. Would suggest change to simpler example such as spironolactone suspension.

Page 24 – use of the table for BUD dating. Most people will read the table in isolation, not reading the ** note. Add line as indicated to have people use published stability data to establish BUD.

Table 1 BUD for Non-sterile Preparations by Type of Formulation

For Formulations with Published Stability Data – BUD is the date as established in the published data. For Nonaqueous Formulations – The BUD is not later than the time remaining until the earliest expiration date of any API or 6 months, whichever is earlier. For Water- Containing Oral Formulations – The BUD is not later than 14 days when stored at controlled cold temperatures. For Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations – The BUD is not later than 30 days.

For water – containing oral formulations, and a BUD of 14 days in the fridge, in the absence of stability data, this seems rather long. Our institution does not allow for formulations to be made in the absence of stability. We would do a process called “dissolve and dose” immediately prior to administration, rather than advanced formulation of “lets throw that into water and give it a 2 week expiry”.

Page 26 – SDS sheets – section 7.3.1 …about the risks and preventive measures that apply to the use of active pharmaceutical ingredients (raw chemicals). Rather than “products “ as people mistakenly look for SDS sheets for drugs which are exempt from SDS requirements.

Page 27 – purified water – this needs a definition.

Page 41 – unpacking hazardous products. This procedure is difficult to implement because shipping regulations only mandate that packages from pharmaceutical manufacturers or wholesalers be given an external label as containing cytotoxic drugs – not all hazardous products. Therefore any pharmaceutical shipment can arrive and contain hazardous products which will not be known until the package is opened.

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