Guest guest Posted June 25, 2003 Report Share Posted June 25, 2003 Yes, We all have to be so careful this day and age ( Thanks Helen for the post, it is shocking isn't it? Anne Signature Creations by PANDORASBOX8 angelbear1129@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 24, 2005 Report Share Posted July 24, 2005 Hi Janet, From the information I could find, it appears that the pharmacy is not responsible for contacting patients in the event of a Class I Recall. It is the responsibility of the drug manufacturer to contact anyone who may have recieved the product. Although individual pharmacies may have their own policies pertaining to recalls, none of those are put in place or enforced by the FDA. I tried to cut/paste this section from the FDA rules but it won't copy correctly. You can read the law under Title 21 Food and Drugs Chapter 1 Food and Drug Administration, Department of Health and Human Services Part 7 Enforcement Policy. Or you can try the link below. http://tm.ask.com/r?t=c & s=a & sv=0a300518 & uid=0C52D05A7F91A8C24 & sid=10A23E0A149824\ E24 & o=0 & id=30787 & p=%2Ffr & u=http%3A%2F%2Fwww.access.gpo.gov%2Fnara%2Fcfr%2Fwaisid\ x_02%2F21cfr7_02.html -Textpert Apr<24>2002 15:16 May 02, 2002 Jkt 197062 PO 00000 Frm 00083 Fmt 8010 Sfmt 8010 Y:\SGML\197062T.XXX pfrm13 PsN: 197062T -- To love what you do and feel that it matters - how could anything be more fun? -- Graham .. . . for my heart rejoiced in all my labour . . . Ecclesiastes 2:10 -------------- Original message -------------- Dear all, I see that you all have been very busy with the testtakers! I do appreciate all that are so willing to help! anyway, the nature of my question is this... Is there a required length of time that a pharmacy is supposed to contact patients in the event of a recall? Thanks, Janet Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 25, 2005 Report Share Posted July 25, 2005 Dear , While it is the responsibility of the firm or mfg to recall this includes contacting all consignees. A consignee is defined in the definitions as a purchaser, user etc. This includes the pharmacy and the pt. Below you will find the pharmacy must take appropriate action in the Recall of a Class I . See the 'effectiveness checks' for this info. Cutting a pasting from the text files i s better than from PDF file. Still I see no mention of time. Hope this helps Jeanetta Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR7.42] [Page 81] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 7--ENFORCEMENT POLICY--Table of Contents Subpart C--Recalls (Including Product Corrections)--Guidance on Policy, Procedures, and Industry Responsibilities Sec. 7.42 Recall strategy. (a) General. (1) A recall strategy that takes into account the following factors will be developed by the agency for a Food and Drug Administration-requested recall and by the recalling firm for a firm- initiated recall to suit the individual circumstances of the particular recall: (i) Results of health hazard evaluation. (ii) Ease in identifying the product. (iii) Degree to which the product's deficiency is obvious to the consumer or user. (iv) Degree to which the product remains unused in the market-place. (v) Continued availability of essential products. (2) The Food and Drug Administration will review the adequacy of a proposed recall strategy developed by a recalling firm and recommend changes as appropriate. A recalling firm should conduct the recall in accordance with an approved recall strategy but need not delay initiation of a recall pending review of its recall strategy. ( Elements of a recall strategy. A recall strategy will address the following elements regarding the conduct of the recall: (1) Depth of recall. Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows: (i) Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or (ii) Retail level, including any intermediate wholesale level; or (iii) Wholesale level. (2) Public warning. The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations where other means for preventing use of the recalled product appear inadequate. The Food and Drug Administration in consultation with the recalling firm will ordinarily issue such publicity. The recalling firm that decides to issue its own public warning is requested to submit its proposed public warning and plan for distribution of the warning for review and comment by the Food and Drug Administration. The recall strategy will specify whether a public warning is needed and whether it will issue as: (i) General public warning through the general news media, either national or local as appropriate, or (ii) Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc. (3) Effectiveness checks. The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. A guide entitled ``Methods for Conducting Recall Effectiveness Checks'' that describes the use of these different methods is available upon request from the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. The recalling firm will ordinarily be responsible for conducting effectiveness checks, but the Food and Drug Administration will assist in this task where necessary and appropriate. The recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted, as follows: (i) Level A--100 percent of the total number of consignees to be contacted; (ii) Level B--Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of the total number of consignees; (iii) Level C--10 percent of the total number of consignees to be contacted; (iv) Level D--2 percent of the total number of consignees to be contacted; or (v) Level E--No effectiveness checks. [43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, 1994] [[Page 82]] --- cphtgenius@... wrote: > Hi Janet, > > From the information I could find, it appears that > the pharmacy is not responsible for contacting > patients in the event of a Class I Recall. It is > the responsibility of the drug manufacturer to > contact anyone who may have recieved the product. > > Although individual pharmacies may have their own > policies pertaining to recalls, none of those are > put in place or enforced by the FDA. > > I tried to cut/paste this section from the FDA rules > but it won't copy correctly. You can read the law > under Title 21 Food and Drugs Chapter 1 Food and > Drug Administration, Department of Health and Human > Services Part 7 Enforcement Policy. Or you can try > the link below. > http://tm.ask.com/r?t=c & s=a & sv=0a300518 & uid=0C52D05A7F91A8C24 & sid=10A23E0A149824\ E24 & o=0 & id=30787 & p=%2Ffr & u=http%3A%2F%2Fwww.access.gpo.gov%2Fnara%2Fcfr%2Fwaisid\ x_02%2F21cfr7_02.html > -Textpert > > > Apr<24>2002 15:16 May 02, 2002 Jkt 197062 PO 00000 > Frm 00083 Fmt 8010 Sfmt 8010 Y:\SGML\197062T.XXX > pfrm13 PsN: 197062T > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2011 Report Share Posted February 15, 2011 This article points up some of the beefs I have with the present system of device and drug approvals for patient use. Even though this talks about devices, I believe that drug approvals are not obtained in the most optimum of circumstances, and that is why there are dangerous drug recalls too. http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/24875 <>Roni Immortality exists! It's called knowledge! Just because something isn't seen doesn't mean it's not there<> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2011 Report Share Posted February 15, 2011 IMHO some of the medical research if far from impressive. I believe the article on placebos from Wikipedia that I quoted recently [not sure that was it] mentions drug manufacturers doing multiple tests to try to get results above placebo. .. .. > > Posted by: " Roni Molin " matchermaam@... > <mailto:matchermaam@...?Subject=%20Re%3A%20Recalls> > matchermaam <matchermaam> > > > Mon Feb 14, 2011 4:26 pm (PST) > > > > This article points up some of the beefs I have with the present system of > device and drug approvals for patient use. Even though this talks about > devices, I believe that drug approvals are not obtained in the most > optimum > of circumstances, and that is why there are dangerous drug recalls too. > > http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/24875 > <http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/24875> > > > <>Roni Quote Link to comment Share on other sites More sharing options...
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