Section 144-266-3 - EVALUATION OF THE LABORATORY AND PERSONNELA. No person shall be certified unless his work is done in a well organized laboratory which has been inspected and approved by the Department of Human Services. Said Laboratory shall have adequate space, facilities and equipment necessary to assure that competent, professional service is performed. Such equipment shall be maintained in good working order, routinely checked and properly calibrated. Adequacy of equipment and proper maintenance thereof may be checked as deemed necessary by visits by the certifying authority or agent appointed by him.B. Laboratories shall possess a Controlled Substance Registration Certificate as issued by the Drug Enforcement Administration, U.S. Department of Justice.C. For each drug which will be identified, a laboratory shall stock a reference standard sample, if commercially available; reference standards may be prepared by synthesis or by extraction and purification of a drug in dosage form, and checking identity by comparison of its infrared absorption spectrum, mass spectra, or x-ray diffraction pattern with those published in the appropriate scientific literature which shall include but not be limited to:1. Association of Official Analytical Chemists "Infrared and Ultraviolet Spectra of Some Compounds of Pharmaceutical Interest"2. Bureau of Narcotics, United States Dept. of Justice, "Analytical Manual, Analysis of Drugs"3. E.G.C. Clarke, "Isolation and Identification of Drugs", the Pharmaceutical Press, London4. Sunshine and Gerber, "Spectrophotometric Analysis of Drugs", Thomas5. Sadtler Standard Spectra, Philadelphia6. Journal of Forensic Sciences8. The Journals of the American Chemical SocietyD. Certification shall also require satisfactory performance on proficiency testing. In proficiency testing results returned shall include complete data of all tests used to establish proof of identity, such as Rf of controls and samples if TLC is used, retention times in gas chromatography, mass spectra, ultraviolet, infrared or fluorescence spectrophotometer curves if applicable, or such other scientific information as may be required for the identification of the particular scheduled drug involved.
Failure to perform satisfactorily on proficiency test samples shall result in denial or revocation of certification.
If certification is denied because of incorrectly identifying a particular drug, applicant may reapply after 6 months. If denied or revoked because a drug is not identified or because proof of identity is deemed insufficient, applicant may reapply immediately.
E. Proficiency testing shall be made annually.10- 144 C.M.R. ch. 266, § 3