PHA 620 Quiz #3 objectives
References (Orange Book) and generic substitution
Allows one to find and compare therapeutic equivalence codes for multi-source products includes tables which indicate the therapeutic equivalence evaluations (TE), the Reference Listed Drug (RLD), dosage form, strength, proprietary name and applicant The electronic version of the Orange Book is updated regularly. You can search by active ingredient, brand name, application number, or patent number. If you search by active ingredient, you'll get a list of approved products sorted by dosage form and route of administration. For each dosage form and route, there will be a reference listed drug (RLD), which can be identified with "RLD" under the "RLD" column (or a "+" in the printed version of the book) and/or a "reference standard," which can be identified with "RS" under the "RS" column (or a "!" in the printed version of the book). As previously mentioned, the RLD and RS are often the same product. But in cases where the RLD has been withdrawn from sale, the RS may be assigned to a different product. Approved generic products are tested against these "reference" drugs for bioequivalence. Approved generics have a therapeutic equivalence code (listed in the "TE Code" column of the book) which can be used to determine if the generic product is therapeutically equivalent to the reference product. Keep in mind that not all brand-name products are an RLD. To avoid confusion, also look at the "proprietary name" column to identify whether the entry is referring to a brand or generic product. When deciding whether a generic product is therapeutically equivalent to a brand, be sure to also match up the dosage form, route of administration, and strength. This will help you make sure the equivalent generic is matched with the right brand name product. Generic substitution rules apply when a prescription is written for a specific drug, usually indicated by the specific brand name for a drug. Alternatively, when a prescriber writes a prescription using the generic name of a medication, either a brand or generic may be dispensed. In these cases, cost or insurance co- pay will likely influence what the patient receives. Substitution is NOT allowed when prescribers specifically indicate that substitution is not allowed.
Define central fill pharmacy
"Central Fill Pharmacy" shall mean a pharmacy which is permitted by the state in which it is located to prepare prescription orders for dispensing pursuant to a valid prescription transmitted to it by an originating pharmacy and to return the labeled and filled prescriptions to the originating pharmacy for delivery to the ultimate user
Tax-free alcohol purchases for pharmacies
**Found this in my P1 notes** The Bureau of Alcohol, Tobacco, and Firearms (BATF) control/regulate the sale of alcohol Pharmacies can purchase 95% ethanol for routine compounding using Form ATF-11 If a pharmacy is selling alcohol in the form of a beverage, then a retail liquor dealer's stamp is required Prescriber's orders for alcohol-containing beverages may either be purchased by the institution and provided/billed to the patient or permission given to patient's family to bring-in alcohol for the patient's consumption Pharmacies that require a large amount of alcohol may purchase tax-free alcohol using Form ATF-1447 Federal statutes related to the use of tax-free alcohol include: use is limited to medicinal or scientific use (or in patient treatment) The alcohol may not be sold or loaned to other pharmacies or physician offices A running, accurate inventory must be kept for all alcohol in stock Containers of alcohol (usually 10 or 55 gallon drums) must be stored in a securely locked and fire-resistant storage room The alcohol (either alone or as a component of other products) may not be sold to outpatients unless it is a nonprofit clinic and the client is not charged for the medication
Conscientious objection by the pharmacist
**found this in my notes from P1 year** A pharmacist has a right to refuse a dispense a prescription if he/she has moral or religious opposition However, the pharmacist should not obstruct a patient's legal right to receive a lawful medication. "other" arrangement should be made
State (GA) immunization protocol requirements
**found this in my notes from P1 year...help** History: Prior to 2009, pharmacists were "allowed" to immunize but immunizing-pharmacists were not formally recognized in the Pharmacy Practice Act. In 2009, legislation was passed outlining requirements for pharmacists to follow to allow for the lawful provision of pharmacist-provided immunizations. Immunization protocol agreements requirements of the law -Proper Training and Affidavit -Protocol Agreement -Patient Encounters -Documentation Immunization protocol agreement checklist for requirements of the law : -Vaccine Protocol Agreement -Training (CPR/BLS, OSHA & Immunization Certification) -Liability Insurance -Affidavit -GRITS Account Online -Safety Policy and Procedures -Immunization Record Card -Appropriate Patient History -Patient Consent Form A-dverse Events Policy and Procedures (include supplies) -Private Room/Area -Vaccine Information Statements Required by law to be given to patients and must be the most UPDATED form -Vaccine Administration Record -PCP Educational Handout -PCP Notification Form
Rules of Thumb to Remember for Traditional Compounding
-Keep a "Master Formulation Record" or recipe for each product you make. -Record each time you compound a product. -Pharmacists should verify all weights and measures before a technician does the final mixing. -Review and document compounding proficiency annually. -Use ingredients that have a United States Pharmacopoeia (USP) or National Formulary (NF) monograph, meet Food Chemicals Codex (FCC) standards (e.g., are "food grade"), or are on the FDA "Bulks List" (more information provided below). -Don't make specific efficacy claims for products you compound. -Follow state laws for dispensing to medical offices. -Limit the number of compounded Rxs you mail out of state to 5% or less (check with your state board to see if this rule applies in your state). -You can still make batches of compounded products ahead of time, but quantities should be limited to those that match your historical demand based on individual patient Rxs. -Include appropriate beyond-use dates. If not specified in the compounding recipe, refer to current USP guidance for sterile (USP Chapter <797>) or non-sterile compounding (USP Chapter <795>). -Remember that the same rules apply to veterinary meds.
State (GA) requirements for oral contraception prescription authorization
No prescription drug order issued by an APRN can be used to authorize refills more than twelve (12) months past the date of the original drug order unless the prescription drug order is for oral contraceptives, hormone replacement, or prenatal vitamins. Oral contraceptives, hormone replacement and prenatal vitamins may be refilled up to twenty-four (24) months from the date of the original drug order.
Compounding regulations
Pharmacy compounding rules have been in turmoil since a serious meningitis outbreak linked to contaminated compounded products killed 61 patients in 2012. The outbreak was traced back to epidural injections of corticosteroids made by a large-scale Massachusetts compounding pharmacy that functioned more like a mini-drug manufacturer. This tragedy ended in the passage of a new law that creates a voluntary system for compounding facilities to register with FDA. But this isn't the first time compounding facilities have caught the eye of government agencies. To understand where we are today, it's helpful to first review where we've been. In 1992 the FDA wanted to consider compounded products new drugs and apply the same rules to their approval that pharmaceutical manufacturers have to follow, such as filing of a new drug application (NDA) with subsequent FDA review and approval. The FDA felt some large-scale compounding facilities were closer to functioning as pharmaceutical manufacturers than pharmacies. In 1997, the Food and Drug Administration Modernization Act (FDAMA) defined the difference between manufacturing and compounding. This exempted compounded products from the "new drug" rule as long as certain criteria were met: - Prescriptions can only be compounded for an identified individual patient and by a licensed pharmacist. -Bulk drug substances used for compounding must be manufactured by an establishment registered with the FDA. -The prescription isn't for a drug previously found unsafe or ineffective. -The compounded product isn't a copy of a commercially available drug product. In addition, a pharmacy could not promote or advertise the compounding of any drug, class of drug, or type of drug. Promotion and advertising were identified as the territory of drug manufacturers. The water was then muddied by a court case. In 2001 the Ninth Circuit court ruled that the anti-advertising requirement violated free speech rights. Even more interesting, they ruled that the advertising provision could not be extracted from the rest of the compounding statute, making that section of FDAMA unconstitutional. FDA subsequently released a Compliance Policy Guide on compounding in which they made it clear they would continue to defer to the states to regulate compounding. But they would consider going after pharmacies that: -Compound drugs in anticipation of prescriptions (except in very limited quantities) -Compound drugs withdrawn or removed from the market due to safety concerns -Compound drugs using bulk active ingredients not approved by the FDA -Use ingredients that don't meet compendia requirements or that aren't from an FDA-approved facility -Use commercial-scale manufacturing or testing equipment to compound -Compound products for a third-party to resell -Compound products that are commercially available or are essentially copies of commercially available FDA-approved products During this time, a group of compounding pharmacies in Texas had the Fifth Circuit court review the Ninth Circuit court's decision regarding the ability to separate the rest of that section from the unconstitutional advertising limitation. They concluded that it could be separated and stated that this section of the FDAMA should be used to determine FDA's involvement with compounding pharmacies. This caused even more confusion over who was in charge. Was it the state boards of pharmacy or was it FDA? Because it was not clear, most compounding pharmacies were not heavily regulated during this time.
Reimportation of prescription drugs
Prescription Drug Marketing Act of 1987 placed control on the distribution process of prescriptions and drug samples and licensing prescription drug wholesalers. It also specified storage/handling requirements for drugs along with prohibiting reimportation of prescription drugs in the US and the resale of drugs purchased by healthcare facilities.
State (GA) required elements for a written prescription
Rule 480-10-.15. Requirements of a Prescription Drug Order. A Prescription Drug Order (defined as a "lawful order of a Practitioner for a Drug or Device for a specific patient") shall include, but not be limited to the following information as well as any information required by Rule 480-22: (1) Full name and address of the patient; (2) Name, address of the prescribing practitioner and DEA registration number in the case of controlled substances; (3) Date of issuance; (4) Name, strength, if needed, dosage form and quantity of drug prescribed; (5) Directions for use by the patient; (6) Refills authorized, if any; (7) If a written Prescription Drug Order, prescribing practitioner's signature; and (8) A serial number assigned by the Pharmacist so that Prescription Drug Orders may be filed in a numerical and retrievable sequence.
State (GA) requirements for central fill pharmacies
Rule 480-10A-.02. Licensing and Contracting (1)All pharmacies providing central filling services to retail pharmacies in Georgia must be appropriately licensed in Georgia. (2)A central fill pharmacy shall be deemed "authorized" to fill prescriptions on behalf of an originating pharmacy only if the parties have a contractual relationship permitting such activity or share a common owner. (a)The contract or agreement shall outline the services to be provided and the responsibilities and accountabilities of each pharmacy, in relation to such services, in compliance with federal and state laws, rules and regulations. (b)Central prescription filling of controlled substances requires compliance with all Drug Enforcement Administration ("DEA") regulations permitting a central fill pharmacy to fillprescriptions for controlled substances on behalf of an originating pharmacy as well as state laws, rules and regulations. (3)The originating and central fill pharmacy shall be jointly responsible for all prescriptions filled utilizing central fill services. ---------------------------------------------Rule 480-10A-.05. Transmission and Labeling (1)The transmission and labeling of controlled substance prescriptions processed utilizing central fill services must comply with all federal and state laws, rules, and regulations. (2)The originating pharmacy must comply with the minimum required information for the patient record system and all requirements of a prescription drug order as outlined in the Georgia law and Board rules prior to sending a prescription to the central fill pharmacy. (3)All prescriptions may be transmitted electronically from an originating pharmacy to a central fill pharmacy including via facsimile. (4)All transmission records must include the following: (a)"CENTRAL FILL" written on the face of a prescription if it is a hard copy prescription (b)The name, address, telephone number, Georgia license number, and DEA registration number (if the prescription is a controlled substance), of the central fill pharmacy to which the prescription has been transmitted (c)Number of refills already dispensed and number of refills remaining (if applicable) (d)The name of the originating pharmacy pharmacist transmitting the prescription, and (e)The date of transmittal. (5)All receipt of transmission records must include all information included in subsection 4 and the name, address, telephone number, Georgia license number, and DEA registration number (if the prescription is a controlled substance), of the originating pharmacy transmitting the prescription. (6)The label affixed to the container of a dangerous drug or other non-controlled substance filled by a central fill pharmacy must contain the following: (a)Date of fill or refill (b)The originating pharmacy name, address, and telephone number (c)The central fill pharmacy's unique identifier (d)The serial number of the prescription (e)The name of the patient (f)The name of the prescribing practitioner (g)Name of supervising physician if applicable (h)Expiration date of the dispensed drug, and (i)The directions for use and cautionary statements, if any, contained in such prescription or required by law. --------------------------------------------- Rule 480-10A-.06. Information Systems, Record Keeping, and PDMP Compliance (1)The originating and central fill pharmacies must share common electronic files or have appropriate technology to allow secure access to sufficient information necessary or required to process and dispense the prescription. (2)The originating pharmacy shall be responsible for maintaining compliance with the Prescription Drug Monitoring Program for all qualifying prescriptions pursuant to O.C.G.A. 16-13-59 including those filled utilizing central fill services. (3)The record keeping of prescriptions processed utilizing central fill services must comply with all federal and state laws, rules, and regulations. (4)The originating pharmacy must have a pharmacist, pharmacy intern, pharmacy extern, or pharmacy technician sign for the receipt of all prescriptions received from the central fill pharmacy. (a)Such receipts must be maintained as a part of the prescription record. Receipts shall include the date of receipt, the method of delivery (private, common, or contract carrier) and the name of the originating pharmacy employee accepting delivery. (b)The pharmacist on duty at the originating pharmacy must verify the receipt of all controlled substances. (5)The originating pharmacy is responsible for maintaining records of the processing of all prescriptions entered into their information system including prescriptions filled at a central fill pharmacy. (a)The information system must have the ability to audit the activities of the individuals at the central fill pharmacy filling the originating pharmacy's prescriptions. --------------------------------------------- Rule 480-10A-.07. Patient Counseling (1)It shall be the responsibility of the pharmacist on duty at the originating pharmacy to perform patient counseling of all prescriptions. (2)The central fill pharmacy shall not perform patient counseling on behalf of the originating pharmacy.
Section 503A Bulk Substances & Compounding Lists
Section 503A of the Food, Drug, and Cosmetic Act requires compounders to use bulk substances for compounding that either have a USP or NF monograph, are a component of an approved drugproduct, or appear on FDA's "Bulks List" described below. Keep in mind that all bulk substances used for compounding must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA. Certificates of analysis summarize key information on product quality testing to help verify the purity and quality of the ingredients. Section 503A charged the FDA with developing three lists. These include the "Bulk Drug Substances," "Withdrawn or Removed," and the "Demonstrable Difficulties for Compounding" lists. The "Bulk Drug Substances" list, also referred to as the "positive list," or "Bulks List," is intended to provide a list of bulk substances that don't have a USP or NF monograph and aren't components of approved drug products, but still can be used to compound drug products.28 The current list is very short, including only six substances, such as N-acetyl-D-glucosamine (a naturally produced derivative of glucose that gets metabolized into hyaluronic acid which may improve appearance of skin) and squaric acid dibutyl ester (an organic acid that is used for the treatment of warts or alopecia), both for topical use only. FDA continues to review bulk substances nominated for inclusion on this list on an ongoing basis. The "Withdrawn or Removed" list, also referred to as the "negative list," contains all active ingredients which have been withdrawn or removed from the marketplace for issues with safety or efficacy. Examples of substances on this list include cerivastatin (the ingredient in the withdrawn statin, Baycol) and rofecoxib (the ingredient in the withdrawn COX-2 inhibitor, Vioxx). These chemicals cannot be used for human compounding. The "Demonstrable Difficulties for Compounding" list has not been made official yet and is still under review. This will be a list of categories of drugs the FDA believes are too difficult for compounders to make. Examples of drug categories nominated to be placed on this list are metered-dose and dry-powder inhalers as well as several hormone products, such as bioidentical hormone pellets, progesterone or estradiol (both oral and topical), or testosterone pellets.
Drug Quality and Security Act of 2013 - Title 1: Compounding Quality Act
The Compounding Quality Act (CQA), which is Title I of the Drug Quality and Security Act (DQSA) of 2013, picked up where FDAMA and the Ninth Circuit court left off. It removed the "unconstitutional" section of the FDAMA and added new content. The Act clearly defines the difference between traditional pharmacy compounding, which is exempt from the Act and continues to be regulated by state boards of pharmacy, and pharmacies that do large-scale compounding without a specific patient prescription in hand. These large-scale compounders now fall under FDA's scope of oversight. However, FDA has also developed guidance that pharmacies performing traditional compounding should follow. The guidance covers topics such as what constitutes a compounded drug, who is allowed to compound, rules regarding compounding of a drug withdrawn from the market, and rules about bulk drug substances not listed in the USP and that aren't components of FDA-approved drugs. And it lays out what actions FDA may take if compounding rules aren't followed. In the end, the Compounding Quality Act continues to exempt traditional pharmacy compounding practices from the good manufacturing procedures and new drug provisions of the Food, Drug, and Cosmetic Act as long as certain conditions are met. This means you can still compound a sterile or non-sterile drug for an identified individual patient based on a valid prescription. You can also produce limited quantities of compounded products in advance of receiving a prescription, but the quantities should be in line with the numbers of these prescriptions you've received in the past. Be aware, products cannot be compounded using drugs that were removed from the market as unsafe or not effective. You also cannot compound products that are basically copies of commercially available drugs, and the number of out-of-state shipments of compounded products you can make may be limited to 5% of compounded prescription orders dispensed, depending on your state's relationship with FDA. The Compounding Quality Act also requires large-volume compounders to voluntarily register with the FDA as an "outsourcing facility." These facilities have significantly more federal oversight and quality control rules reminiscent of the ones pharmaceutical manufacturers must follow, but they are exempted from the labeling and new drug-approval requirements that conventional manufacturers are held to. These outsourcing facilities pay a yearly fee, have to submit to quality standards and inspections, and must report adverse effects.
Orange book practice: JT comes to your pharmacy to get his prescription for Pristiq (desvenlafaxine succinate extended-release) filled. JT says he doesn't want to use a generic because he's concerned it will not work as well. You look at the prescription and see it is written for Pristiq 50 mg, take one tablet daily, and has allowed for generic substitution. After giving JT more information on generic drugs, he agrees to try a generic version of Pristiq. You realize you are out of the generic desvenlafaxine succinate extended-release 50 mg tablets. But you do have a generic desvenlafaxine extended-release 50 mg base (not a salt form) tablets on the shelf. You look up "desvenlafaxine" in the Orange Book and see that Pristiq (desvenlafaxine succinate) is the RLD, and all of its generics are AB-rated. However, desvenlafaxine base is its own RLD and there is no entry in the "TE Code" column. What does this mean? Does FDA consider these products to be therapeutically equivalent?
The answer is no, desvenlafaxine succinate and desvenlafaxine base are not considered to be therapeutically equivalent according to FDA. Depending on your state law you may or may not be able to automatically substitute these products.
Pharmacist-pharmacy technician ratios for GA
The pharmacist to registered pharmacy technician ratio shall not exceed one pharmacist providing direct supervision of three registered pharmacy technicians. One of the three technicians must: (1)Have successfully passed a certification program approved by the Board of Pharmacy; (2)Have successfully passed an employer's training and assessment program which has been approved by the Board of Pharmacy; or (3)Have been certified by the Pharmacy technician Certification Board. (f)In addition to the utilization of three (3) registered pharmacy technicians, if one is certified, a pharmacist may be assisted by and directly supervise at the same time one (1) pharmacy intern, as well as one (1) pharmacy extern, and one (1) pharmacy observer. (g)The board may consider and approve an application to increase the ratio in a pharmacy located in a licensed hospital. Such application must be made in writing and may be submitted to the Board by the pharmacist in charge of a specific hospital pharmacy in this state. "Current through Rules and Regulations filed through May 23, 2022"
State (GA) requirements for transferring non-controlled prescriptions
The transfer of original prescription drug information for the purpose of refill dispensing is permissible between pharmacies subject to the following requirements: (a) The prescription drug order is transmitted directly to the pharmacy of the patient's choice. (b) The transfer is communicated directly between licensed pharmacists or licensed interns or externs under the direct supervision of a licensed pharmacist and the transferring pharmacist or intern or extern records the following information: 1. The word "VOID" is written on the face of the invalidated prescription drug order, and/or indicate in the pharmacy's electronic data system this prescription is void; 2. Record on the reverse of the invalidated prescription drug order the name and address of the pharmacy to which it was transferred and the name of the pharmacist or intern or extern under the direct supervision of a licensed pharmacist receiving the prescription drug order information, or have the electronic data system reflect the fact that the prescription drug order has been transferred, the name and address of the pharmacy to which it was transferred and the name of the pharmacist or intern or extern under the direct supervision of a licensed pharmacist to which it was transferred, and the date of the transfer; and 3. Record the date of the transfer and the name of the pharmacist or intern or extern under direct supervision of a licensed pharmacist transferring the information. (c) The pharmacist or intern or extern under the direct supervision of a licensed pharmacist receiving the transferred prescription drug order shall reduce to writing, or cause the computer to reduce to writing, the following information which shall be filed as required by O.C.G.A. Title 16, Chapter 13 and Title 25, Chapter 4: 1. The word "TRANSFER" shall be written on the face of the transferred prescription and/or indicate in the pharmacy's electronic data system this prescription was a transfer; 2. All information required to be included on the prescription drug order pursuant to all State and Federal laws and regulations shall be provided which shall include at a minimum the following: (i) Date of issuance of the original prescription drug order (ii) Original number of refills authorized on the original prescription drug order; (iii)Date of original dispensing; (iv)Number of valid refills remaining and date of last refill; (v) The pharmacy's name, address, and original prescription serial number from which the prescription drug order information was transferred; and (vi)Name of transferring pharmacist. 3. Both the original and transferred prescription must be maintained for a period of two years from the date of last refill. (d) Pharmacies accessing a common electronic file or database used to maintain required dispensing information are not required to record on the original hard copy prescription drug order any information when transferring or refilling prescription drug orders as required for pharmacies not utilizing a common electronic file as noted in this Chapter. However, a hard copy of the prescription drug order must be generated and maintained by the pharmacist refilling or receiving the electronically transferred prescription drug order information. The common database must contain complete records of each prescription drug order transferred.
Orange book practice question from law book: which of the following designations indicate that drug products of the same strength and dosage form may be interchangeable? I. A II. AB III.B A) 1 only B) III only C) I & II only D) II & III only E) I, II, & III
C) I & II only
Orange book practice question from law book: The Electronic orange book uses the abbreviation RLD to indicate.... A) a bioequivalence problem B) no bioequivalence problem C) drug product is used as the reference standard D) least expensive drug product E) drug product that is preferred by most pharmacists for substitusion
C) drug product is used as the reference standard
Restricted drug product sales (pseudoephedrine)
Combat Methamphetamine Act The Combat Methamphetamine Epidemic Act (CMEA) of 2005 was signed into law on March 9, 2006. This law establishes federal requirements for the sale of scheduled listed chemical products containing ephedrine, pseudoephedrine, or phenylpropanolamine, which are key ingredients used in the illicit manufacture of methamphetamine and amphetamine. It also includes other key provisions that, among other things, provide resources for law enforcement and toughen international enforcement of trafficking. Sellers of these OTC drug products must follow this law; however, some states and localities have enacted tougher laws regulating the sale of these products. For example, a number of states or localities are requiring, or considering requiring, a prescription for products containing pseudoephedrine. In these areas, you must follow the applicable laws in addition to the federal law. In other words, you always follow the stricter requirements. Federal Logbook Requirements One of the key requirements of the CMEA is that sellers of drug products containing pseudoephedrine, ephedrine, or phenylpropanolamine must maintain a logbook of sales. The logbook can either be written or electronic or a combination of the two. After the customer provides acceptable identification (see Identification Requirements below), one of the following needs to be done to log the sale: -Written logbooks: You enter the name of the drug product and the quantity sold. Your customer enters their name, address, the date and time of the sale, and signs the entry. -Electronic logbooks: The customer signs a device that captures their electronic signature and links it to the rest of the required information that you've either entered or scanned into the computer. -Bound paper logbooks: You place a printed sticker in the book next to the signature line at the time of sale. The sticker must have the product name, quantity purchased, name and address of the customer, and date and time of the sale, OR a unique ID that can be linked to this information. Or you can write in the book the unique identifier that links to the required information. Either way, the customer still must sign the entry. -Printed documents: You print a document at the time of the sale that includes the name of the product sold, the quantity sold, the customer's name and address, the date and time of the sale, and the warning notice below. The customer then signs on a signature line. You must place the signed page in a binder or another secure means of storage immediately after it is signed. The name of the product and the quantity sold can be logged using electronic means such as electronic data capture or a bar code reader. Quantity can be reported by weight per package and number of packages sold; the total weight for each chemical sold; the quantity, using the Universal Product Code; or through electronic means. As the individual selling the product, it's your responsibility to make sure the name entered by the customer matches their identification and that the date and time of the sale entered by the customer is correct. In cases where the customer cannot enter the information themselves, you should ask for their name and address and enter it for them, not simply copy it from their photo ID. If you are the one entering that data, then the customer must verify that the information you logged is correct. The logbook must be kept in a secure spot. You can share the log information to comply with law enforcement or for a product recall, but ONLY with local, state, or federal law enforcement. Sharing the information may include copying the logbook, allowing inspection of it, or turning the book over to authorities. Always talk to your supervisor or follow company policy before sharing logbook information. If you release logbook information in good faith to law enforcement authorities, you are immune from civil liability for releasing the logbook unless it constitutes gross negligence or intentional, wanton, or willful misconduct. The logbook, whether hardcopy or electronic, must contain the following statement to purchasers: WARNING: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device, a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both. Your pharmacy is required to maintain the log for a period of two years after the date of its last entry. Unless your pharmacy has notified the DEA, these records must be kept at your pharmacy and be readily retrievable for inspection and copying by the DEA If additional, more stringent state requirements exist, you must follow these, but also meet the federal requirements. In other words, the DEA sets the floor for logging the sale of these products, but not the ceiling. States can, and often do, impose additional requirements. Identification Requirements Another important requirement of the CMEA is that customer identity must be verified at the time of purchase of any regulated products. Customers must show state or federal government-issued photo identification, such as a driver's license or state ID card. You cannot sell these products to a customer who doesn't have the appropriate identification. However, if a customer doesn't have a driver's license or state ID card, he/she may use an acceptable alternate form of ID. (Be sure to verify age if state law or company policy has age limits for the purchaser.) You must verify that the name on the photo ID matches the name the customer wrote in the logbook. You must also verify that the date and time the customer wrote in the logbook are correct, unless you wrote them; then the customer should verify your entry is correct. Once the logbook entry is complete and you've verified the above items, you can give the product directly to the customer who signed for it. Exclusions from Logbook and ID Requirements Per Federal law, the ONLY time a customer does not have to sign the logbook to purchase OTC pseudoephedrine is when they are buying a single package of a product containing not more than 60 mg of pseudoephedrine (one 60 mg tablet or two 30 mg tablets). They don't have to show ID in this case either. This exclusion DOES NOT apply to ephedrine or phenylpropanolamine. Storage of Scheduled Listed Chemical Products Non-liquid dosage forms (including gel caps) of pseudoephedrine, ephedrine, and phenylpropanolamine must be in blister packs or unit-dose packaging, if blister packs aren't feasible. Per federal law, products containing these ingredients must be stored either behind the counter or in a locked cabinet. Some state laws are more restrictive about storage requirements. When a product containing one of these ingredients is being purchased you must give it directly to the customer who signs the logbook. Federal Limits on the Sale of Scheduled Listed Chemical Products - LISTED AS THE BASE (NOT THE SALT FORM) OF THE DRUG: - You cannot sell more than 3.6 g PER DAY of pseudoephedrine, ephedrine, or phenylpropanolamine BASE to a customer. -Your customer cannot buy more than 9 g of the BASE form of drug products containing these ingredients IN A 30-DAY PERIOD. -Mail-order customers cannot buy more than 7.5 g of the BASE IN A 30-DAY PERIOD.
Duties and responsibilities of the pharmacist
From Title 26: Duties requiring professional judgment; responsibilities of licensed pharmacist (a) In dispensing drugs, no individual other than a licensed pharmacist shall perform or conduct those duties or functions which require professional judgment. It shall be the responsibility of the supervising pharmacist to ensure that no other employee of the pharmacy, including pharmacy technicians, performs or conducts those duties or functions which require professional judgment. (b) For all prescriptions, it shall be the responsibility of the pharmacist on duty at a facility to ensure that only a pharmacist or a pharmacy intern under the direct supervision of a pharmacist provides professional consultation and counseling with patients or other licensed health care professionals, and that only a pharmacist or a pharmacy intern under the direct supervision of a pharmacist accepts initial telephoned prescription orders or provides information in any manner relative to prescriptions or prescription drugs. (c) In the dispensing of all prescription drug orders: (1) The pharmacist shall be responsible for all activities of the pharmacy technician in the preparation of the drug for delivery to the patient; (2) The pharmacist shall be present and personally supervising the activities of the pharmacy technician at all times; (3) When electronic systems are employed within the pharmacy, pharmacy technicians may enter information into the system and prepare labels; provided, however, that it shall be the responsibility of the pharmacist to verify the accuracy of the information entered and the label produced in conjunction with the prescription drug order; (4) When a prescription drug order is presented for refilling, it shall be the responsibility of the pharmacist to review all appropriate information and make the determination as to whether to refill the prescription drug order; and (5) Pharmacy technicians in the dispensing area shall be easily identifiable. (d) The board of pharmacy shall promulgate rules and regulations regarding the activities and utilization of pharmacy technicians in pharmacies, including the establishment of a registry as required in paragraph (7) of subsection (a) of Code Section 26-4-28; provided, however, that the pharmacist to pharmacy technician ratio shall not exceed one pharmacist providing direct supervision of three pharmacy technicians. The board may consider and approve an application to increase the ratio in a pharmacy located in a licensed hospital. Such application must be made in writing and must be submitted to the board by the pharmacist in charge of a specific hospital pharmacy in this state. One of the three technicians must: (1) Have successfully passed a certification program approved by the board of pharmacy; (2) Have successfully passed an employer's training and assessment program which has been approved by the board of pharmacy; or (3) Have been certified by either the Pharmacy Technician Certification Board or any other nationally recognized certifying body approved by the board of pharmacy. (e) In addition to the utilization of pharmacy technicians, a pharmacist may be assisted by and and directly supervise one pharmacy intern and one pharmacy extern.
NAPLEX/MPJE testing requirements
In all states, the written test required for licensure is the North American Pharmacist Licensure Examination (NAPLEX). In addition, states administer an examination on state and federal laws, either one developed specifically by that state or the Multistate Pharmacy Jurisprudence Exam (MPJE) administered under the auspices of the NABP.
