{"id":4340,"date":"2022-06-10T09:51:31","date_gmt":"2022-06-10T13:51:31","guid":{"rendered":"https:\/\/a4pc.org\/?p=4340"},"modified":"2022-06-10T09:51:31","modified_gmt":"2022-06-10T13:51:31","slug":"cc-june-10-2022","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-06\/cc-june-10-2022\/","title":{"rendered":"CC: June 10, 2022"},"content":{"rendered":"
News about what’s happening in our industry<\/span><\/div>\n
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The voice for pharmacy compounding \u2502 10 June 2022<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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From APC’s President<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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A win for Glutathione\u00a0<\/span><\/p>\n

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Look at that graphic on the right: does it represent one of the most dangerous substances on earth?\u00a0It is made from glycine, cysteine, and glutamic acid. It is produced by the liver and involved in many body processes.<\/p>\n

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But lately, some regulators have taken extreme enforcement positions against this \u201cdangerous substance\u201d when used in pharmacy compounding.<\/p>\n

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Of course, this substance is glutathione. You can purchase glutathione from any health food store or vitamin shop in the country. Yet, the position of some is that it is illegal to compound.<\/p>\n

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This week, the FDA\u2019s Pharmacy Compounding Advisory Committee met to discuss changing the status of glutathione from a 503A Category I substance to inclusion on FDA\u2019s list of bulk substances that can be used in compounding.\u00a0<\/p>\n

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APC board member A.J. Day gave compelling evidence in support of glutathione to the PCAC. Even though his testimony was hurried by the PCAC hosts, he did a fantastic job.\u00a0\u00a0<\/p>\n

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For once, sanity seemed to prevail.\u00a0The PCAC voted 8 to 5 to add glutathione to the FDA\u2019s list of bulk substances that can be used in compounding.\u00a0We are hopeful that the FDA will accept the recommendation of the PCAC, although the agency is not bound to do so.<\/p>\n

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APC and our allies will continue to fight for your right to make customized medications.\u00a0Thank you for your membership.\u00a0It\u2019s only with you and your generosity that we can fight these fights.\u00a0Thank you for your investments in\u00a0CompPAC, One Fund and the Legal Action Fund<\/a>.\u00a0You make these fights happen.<\/p>\n

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\u2022 \u2022 \u2022<\/span><\/p>\n

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David Miller\u00a0is APC\u2019s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at\u00a0<\/span>drdave@keystonepharm.com<\/a>.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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This week<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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PCAC recommends glutathione for bulks list<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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FDA\u2019s Pharmacy Compounding Advisory Committee this week voted to recommend that FDA add glutathione to the final 503A Bulks List, signaling that it can be compounded. The 8-5 vote, with one abstention, is not binding on FDA, however.<\/p>\n

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\u201cAs with methylcobalamin last year, the committee bucked the FDA staff\u2019s recommendation against adding glutathione to the bulks list,\u201d said APC\u2019s Scott Brunner. \u201cAnd just as with methylcobalamin, now we wait to see what formal action FDA may take on PCAC\u2019s recommendation.\u201d<\/p>\n

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Representing PCCA and NCPA, APC board member and PCCA Vice President of Clinical Services A.J. Day made a case to the committee for why the substance should be added to the bulks list.<\/p>\n

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\u201cA.J. did a heroic job dismantling FDA\u2019s inaccurate assessments of research that the agency referenced to argue against the addition of glutathione,\u201d said Brunner, \u201cAnd he did it under duress. While the FDA had a fairly unlimited time to present to the committee, A.J.\u2019s presentation was limited, and he was cut off before completion.<\/p>\n

He was forced to speak incredibly rapidly, yet still made a thorough case for why FDA was off base in its recommendation.\u201d<\/p>\n

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\u201cThis is a win, thanks to A.J., and we\u2019ll take it,\u201d added Brunner. \u201cBut we simply must protest this PCAC process, from the insufficient time to review materials prior to the meeting to the limit of a 10-minute presentation per substance to the lack of any deliberation at all among committee members. We will raise it at next week\u2019s compounding listening session with FDA for sure.\u201d<\/p>\n

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In addition to glutathione, PCAC considered three additional substances for the 503A Bulks List in its meeting this week. The other three are ferric subsulfate, enclomiphene citrate, and ammonium tetrathiomolybdate. Only glutathione received the committee\u2019s recommendation.\u00a0PCAC also voted to add lorcaserin hydrochloride to the Withdrawn or Removed List, which affects 503A and 503B compounders.<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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Got “the right stuff”?<\/span><\/h3>\n

APC Fellow nominations due June 30<\/span><\/h3>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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The APC Fellows Program recognizes pharmacists and pharmacy technicians who are exemplary in their professionalism and commitment to the practice of pharmacy compounding.<\/p>\n

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Interested candidates must be registered pharmacists or pharmacy technicians who are APC members and who have practiced pharmacy for at least five years and practiced in the compounding pharmacy profession for at least three years.<\/p>\n

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The application deadline is June 30, 2022.\u00a0Click here<\/a> to learn more about the requirements and to submit an application.<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n
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Show your APC membership pride<\/h3>\n

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Want to flaunt your APC membership on your website, business card and\/or email signature? Individual and Pharmacy\/Facility Members (PFMs) can do just that.<\/span><\/p>\n

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Click on the appropriate link below, then complete, sign and return the agreement. Upon completion, we’ll send you the appropriate logos so you can start showing your APC pride.<\/span><\/p>\n

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