Alabama Board of Pharmacy



Authority to Prescribe

1. Can certified nurse practitioners and PAs write prescriptions for C-II controlled substances?

Certified nurse practitioners and PAs can write prescriptions for C-II controlled substances if the following requirements have been met:

  1. Must be registered with the Board of Medical Examiners with a DEA # and have the practice registration amended to include C-IIs.
  2. Must have a current collaborative practice agreement.
  3. Must have an active QACSC (Qualified Alabama Control Substance Certificate)--allows writing of C-III through C-V prescriptions.
  4. Must have an active LPSP (Limited Purpose Schedule II Permit)--an extension of the QACSC to include practice specific C-II prescriptions. The permit number will be the same as the QACSC certificate number

? The medication being prescribed must fall within the practitioner’s scope of practice and listed in the formulary set forth by the collaborating physician. In order to verify which CIIs are allowed to be prescribed by a practitioner, visit the Alabama Board of Medical Examiner’s website: www.albme.org


2. Can certified nurse practitioners and PAs write prescriptions for C-III through C-V controlled substances?

According to the Alabama Board of Medical Examiners & Medical Licensure Commission of Alabama,

“The Alabama Legislature has passed Act 2013-223 which confers to Certified Registered Nurse Practitioners and Certified Nurse Midwives authority to prescribe controlled substances in Schedules, III, IV, and V. The Board (Medical Board) will act as the certifying board and issue Qualified Alabama Controlled Substances (QACSC) certificates in much the same way that Physician Assistants are issued QACSCs, that is, a CRNP/CNM in a collaborative agreement with a physician may apply for a QACSC to prescribe controlled substances in Schedules III, IV and V without a collaborating physician’s review or signature, provided such is agreed to in the collaborative practice agreement.”

To qualify for a controlled substances certificate, a CRNP or CNM must:

  1. Be in a collaborative practice with a physician who holds a valid, unrestricted ACSC (Alabama Controlled Substances Certificate)
  2. Submit documentation of attendance at an eight credit, Board approved course entitled, “Prescribing Controlled Drugs,” plus attendance at four credits of advanced pharmacology and controlled substance prescribing trends. These courses became available this past summer for those interested.
  3. Provide documentation of a minimum of 12 months of active clinical practice pursuant to an approved collaborative. Once the required information is submitted to the Medical Board, The applicant must submit a form to DEA. DEA will confirm with the Alabama Medical Board that the person is approved for authority to prescribe controlled substances, and will provide the nurse with a DEA number. Look for the nurse’s DEA number on prescriptions you receive from the nurse. Unlike physician assistants, no limitations were legislated on the prescribing rights of CRNPs and CNMs. There is not a limit in the number of doses prescribed, or the number of refills allowed other than those already in the law for physicians.


Expiration Dating

1. Do prescription orders or prescription documents have an expiration date?

Non-controlled legend drugs: There is no expiration date for a prescription for any noncontrolled legend drug

Schedule III--V controlled substances: Prescriptions for schedule III-V controlled substances expire 6 months after the written date on the prescription

Schedule II controlled substances: There is no expiration date for prescriptions written for schedule II controlled substances; however, they may only be written for a 90 day supply maximum.

2. If a patient does not pick up his or her prescription and the medication is returned to stock, what is the resulting expiration date?

If the stock bottle for that medication has been thrown away, the resulting expiration date is either the expiration date on the label or 12 months, whichever date is less. If the stock bottle has not been thrown away, it is acceptable to use the expiration date printed on the stock bottle.



Labeling

1. Must a prescription label state the drug's generic name?

The prescription label may contain the brand name, generic name, or both

2.What are the requirements for the content of a label?

The label must contain the phrase “Caution, federal law prohibits dispensing without a prescription”

The label must also contain the name and address of the pharmacy, name of the prescriber, the name of the drug being dispensed, the directions for use, the serial number,

3. What should be on the label of a prescription?

The following is required to be on the label of a prescription:

  • Name and address of the dispensing pharmacy
  • Serial number of the prescription
  • Date of the prescription
  • Name of the prescriber
  • Name of the patient
  • Name and strength of the drug
  • Directions for use
  • Appropriate cautionary statements, such as “do not take with food” or “shake well”
  • The expiration or discard date.
  • “Filled by” or “dispensed by” with at least the first initial and last name of the dispensing pharmacist.


Prescriptions: E-prescribing

1. May a pharmacist process Schedule II through V prescriptions using e-prescribing?

Yes, assuming the proper requirements for proper e-prescribing have been met.

2.What are the record requirements for e-prescribed controlled substances?

All records must be backed up daily and stored for a minimum of 2 years

3.What are the options for prescribers to be credentialed?

The prescriber must be credentialed. The prescriber must use two of these three credentials:

  • a password or response to a challenge question
  • a biometric, such as a fingerprint or iris scan
  • a hard token, such as a cryptographic module

The act of applying the two credentials ensures the legal electronic signature on the prescription. The software should not permit the transmission of the controlled e-prescription unless the prescription is properly signed by a credentialed prescriber using the two-factor system.

4. What are the software requirements for e-prescribing controlled substances?

The software used by the prescriber and the software used by the pharmacy must be audited by a third party, and that third party must be approved by the DEA. In the situation where the prescription has been digitally signed by the prescriber using his or her private cryptographic key, the pharmacy software must be able to apply the prescriber’s public key to confirm that the prescription was, in fact, signed. The software must check to verify that the prescriber’s digital certificate is still valid and has not been revoked. Otherwise, the software must be able to read and/or display the transmitted flag indicating that the prescription was signed. The soft must retain the full DEA number of the prescriber. On receipt of a controlled-substance e-prescription, the software must digitally sign the prescription. The digitally signed prescription must then be archived by the software. The pharmacy software must have logical access controls that restrict access by name or role. The software must store all applicable dispensing information, such as the number of units dispensed. it must also have an internal audit trail, and must perform automated internal audits and provide reports of incidents to the pharmacist.



Technicians

1.What is a pharmacy technician?

An individual, other than an intern, extern, or an assistant pharmacist, who performs pharmacy functions under the direct supervision of a licensed pharmacist

2.What is the role of the pharmacy technician?

A pharmacy technician shall not perform pharmacy functions or be present in the prescription department of a pharmacy unless he or she is under the direct supervision of a licensed pharmacist. A pharmacy technician shall not perform pharmacy functions or be present in the prescription department of a pharmacy unless he or she is registered by the board.

When supervision is required, a licensed pharmacist shall be jointly responsible and liable for the actions of a pharmacy technician.

3.Are there continuing education requirements for a pharmacy technician?

In addition to any other registration requirements, a pharmacy technician shall complete three hours of continuing education annually, of which one hour shall be live presentation.

4. If a technician chooses not to practice as a pharmacy technician any longer, are they required to keep their license current?

No. However, if that person wants to re-enter the pharmacy technician field in the future, they will have to pay back fees plus penalties to get their lapsed license current. The person is not able to re-enter the technician profession using a new technician application.

5. If a technician registers for the first time any time in the calendar year, are they required to obtain the full three (3) hours of continuing education the first year?

No. They will be required to obtain the full three (3) hours the first full year of registration.

6. Can a technician carry over CE hours from one year to the next year?

No. A technician must obtain three (3) hours of continuing education each year with one (I) hour being a "live" credit hour. CE hours must be earned each calendar year.

7. When does a technician need to submit for a renewal registration?

Technician renewals are biennial on odd years. Registration starts October 1st and is null and void on December 31st of the expiring registration year.



Faxing Prescriptions

1. Can prescription orders be transmitted by fax in Alabama?

All non-controlled substances and schedule III-V prescriptions may be transmitted via fax. Schedule II medications may not be faxed unless the patient is under hospice care or in a long term care facility.



Licensing

1.How soon must I notify the ALBOP with change of employment?

You must notify ALBOP within 10 days of change of employment.

2.How often must a pharmacist renew their license?

Must renew biennially on even numbered years (license expires December 31st of that year).

3.How many continuing education (CE) hours must a pharmacist obtain each year?

A pharmacist must obtain 15 ACPE approved CE hours, requiring 3 of those hours to be “live”

4.How often must a pharmacy technician renew their license?

Must renew biennially on odd numbered years.

5. How many continuing education (CE) hours must a pharmacy technician obtain each year?

A pharmacy technician must obtain 3 ACPE approved CE hours annually, requiring 1 of those hours to be “live.” (§ 34-23-131).

6. If a pharmacist completes more than 15 ACPE approved CE hours in one year can extra hours be carried over to the next year to use?

Yes, up to 12 extra CE hours can be carried over to the next year but once carried over they cannot count towards “live” hours regardless of whether or not they were completed “live” at the time.



Non-Sterile Compounding

1.If I am a retail/ independent pharmacy and conduct non- sterile compounding are there additional rules and regulations I must abide by?

Yes, USP 795

2.Can a pharmacist compound a preparation using all over-the-counter drugs and sell the compounded preparation without a prescription?

A pharmacy may prepare a compounded drug product to be sold over the counter without a prescription order. The product shall not contain an ingredient that exceeds recommended strengths and doses for over the counter drugs. The finished product shall not be one for which a prescription is required. It shall be properly labeled with the product’s name, directions for use, list of active ingredients, and any necessary warnings. A compounded product shall be sold directly to the consumer after professional interaction or consultation between the pharmacist and the consumer. The product may be prepared in advance in reasonable amounts in anticipation of estimated needs. The product shall be stored within the prescription department. The product may not be sold in bulk to other pharmacies or vendors for resale.



Prescribers Treating Family Members/Self

1. Under what circumstances can physicians treat themselves or members of their immediate families?

Physicians generally should not treat themselves or members of their immediate families except in emergency settings or isolated settings where there is no other qualified physician available and only until another physician becomes available. Prescribing or dispensing a controlled substance to oneself or to one’s spouse, child, or parent is not allowed unless such prescribing or dispensing is necessitated by emergency or other exceptional circumstances.

2. What is the process for pharmacists if they suspect a physician is writing prescriptions for family members or themselves?

Pharmacists should contact the Board of Medical Examiners if they experience physicians writing controlled substances to family members, or especially to themselves. It can avert future problems for the physician who is simply acting out of ignorance or be the catalyst for help for an impairment issue.



Prescriptions: Noncontrolled Substances

1.What must be included as the content of the prescription?

Alabama pharmacy law does not designate fully what must be included on a prescription. We have used information found in the Code of Federal Regulations, Title 21, part 1300, which refers primarily to controlled drugs. Alabama law does require that there be two signature lines on each prescription.

Federal regulations state the prescription should include the name and address of the patient; name, address, and DEA number of prescriber; name, strength, dosage form, quantity of the drug prescribed; directions for use, number of refills, and signature of the prescriber. A prescription may only include one page and may not be multiple pages with a signature at the end. A prescription should be for one patient.



Weight Loss Medications

1.May a physician prescribe a Schedule II controlled substance for patients for the purpose of weight reduction?

No

2.May a physician or agent of a physician call in orders for controlled substances for patients for the purpose of weight reduction?

No

3.May anyone other than a licensed MD or DO prescribe controlled substances for weight reduction?

Only a doctor of medicine or doctor of osteopathy licensed by the Medical Licensure Commission of Alabama may order, prescribe, dispense, supply, administer or otherwise distribute a controlled substance in Schedule III, IV or V to a person for the purpose of weight control, weight loss, weight reduction or treatment of obesity, except that a Physician Assistant, Certified Registered Nurse Practitioner or Certified Nurse Midwife may prescribe Belviq® or Qsymia(TM) for such purpose. If a Physician Assistant, Certified Registered Nurse Practitioner or Certified Nurse Midwife prescribes Belviq® or Qsymia(TM), the prescriber shall comply with the guidelines and standards of this Chapter which apply to M. D.s and D. O.s.

4. May a prescription or order for any controlled substance for a patient for the purpose of weight loss or treatment of obesity be called into the pharmacy?

No, such prescriptions may not be called in to a pharmacy by the physician or agent of the physician. Such prescriptions may be written or e-prescribed.

5. What is the maximum days’ supply a physician may prescribe for a weight loss medication?

Physicians may only prescribe a maximum of 35 days’ supply of medication. At the end of that prescription, the patient must be seen by the physician, a physician assistant, or a certified registered nurse and should be evaluated. If medically established goals have been met, the patient may have another prescription for a 35 day supply.

6. Under what circumstances may a patient be eligible for a prescription for a weight loss medication?

The patient should have any of the following before being prescribed a weight loss medication:

  • Body Mass Index (BMI) of 30 or above
  • Body Mass Index (BMI) of greater than 25 with at least one comorbidity factor
  • Male patients: A measurable body fat content greater than or equal to 25% of total body weight
  • Female patients: A measurable body fat content greater than or equal to 30% of total body weight
  • Male patients: An abdominal girth of at least 40 inches.
  • Female patients: An abdominal girth of at least 35 inches
7. Under what circumstances may a prescription for weight loss medication be refilled?

After an original prescription for Qsymia® or Belviq® and an office visit for evaluation, the prescription may be refilled up to 5 times in a six month period. Refills are specific to brand name drugs Qsymia® and Belviq®, and refills are not allowed for generic substitutes or for individual prescriptions of phentermine or topiramate.

7. What are some examples of weight loss drugs covered by this policy?
  • Belviq® (lorcaserin)
  • Qsymia® (phentermine and topiramate)
  • Fastin® (phentermine)
  • Adipex® (phentermine)
  • Suprenza® (phentermine)
  • Tenuate® (diethylpropion)
  • Bontril® (phendimetrazine)
  • Ionamin® (phentermine resin)
  • Didrex® (benzphetamine)


Destruction of Unwanted Medications

1.What are my options for disposing of unwanted medications?

Many community-based drug “take-back” programs offer the best option. A small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed. Many of these medicines have specific disposal instructions on their labeling or patient information leaflet. CLICK HERE for a list of medications recommended by the FDA for disposal by flushing and more information concerning medication destruction.

2.Are there guidelines in place for proper disposal of unwanted medications?

The following guidelines were developed to encourage the proper disposal of medicines and help reduce harm from accidental exposure or intentional misuse after they are no longer needed:

  • Follow any specific disposal instructions on the prescription drug labeling or patient information that accompanies the medicine. Do not flush medicines down the sink or toilet unless FDA safe disposal of medicine states you can?
  • Take advantage of programs that allow the public to take unused drugs to a central location for proper disposal. Call your local law enforcement agencies about take back or contact your city or county government’s household trash and recycling service to learn about medicine disposal options and guidelines for their area.
3.What if there are no medicine take-back programs in my area?

If no medicine take-back programs or DEA-authorized collectors are available in your area, you can also follow these simple steps to dispose of most medicines in the household trash:

  • Mix medicines (do not crush tablets or capsules) with an unpalatable substance such as dirt, kitty litter, or used coffee grounds;
  • Place the mixture in a container such as a sealed plastic bag;
  • Throw the container in your household trash;
  • Scratch out all personal information on the prescription label of your empty pill bottle or empty medicine packaging to make it unreadable, and then dispose of the con


MEDICATIONS FOR THE TREATMENT OF ADDICTION

1.Can Suboxone be used for pain management? (Check with calling in for addiction and confidentiality.)

Yes. If the physician writes a prescription for Suboxone for pain management, the prescription may be called in to the pharmacy. Suboxone prescriptions for addiction management may not be called into the pharmacy.

2.What other information should I relay to patients?

It is important that you make sure patients understand the instructions from the physician, and that you answer any questions they may have. When counseling patients, be sure to discuss any relevant precautions as listed in the prescribing information, including but not limited to the following:

  • Patients should be cautioned that a serious overdose may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as Suboxone or Subutex.
  • Patients should be cautioned that Suboxone or Subutex may impair the mental or physical abilities required for the performance of potentially dangerous tasks, such as driving a car or operating machinery. Patients should be cautioned not to drive or operate complex machinery until they know how Suboxone or Subutex affects their ability to function in these circumstances
  • Patients should consult their physician if other prescription medications are currently being used or are prescribed for future use.
3.What is the role of the pharmacist in ensuring safe use of Suboxone and Subutex?

Each time a pharmacist fills a prescription for Suboxone or Subutex, he or she must:

  • Verify that the prescriptions received are from physicians who are in compliance with the provisions of the Drug Addiction Treatment Act (DATA).
  • Remind patients who are picking up induction doses to return as directed to the doctor’s office so that they can be supervised while taking the medication.
  • Be vigilant in detecting fraudulent prescriptions or simultaneous prescriptions for the same patient from multiple suppliers.
4. Who is qualified to prescribe Suboxone and Subutex?

The DATA limits office-based use of Suboxone and Subutex to physicians who meet special training criteria and can provide appropriate services. To be qualified, physicians must meet one or more of the following training requirements:

  • Hold a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties
  • Hold a subspecialty board certification in Addiction Medicine from the American Osteopathic Association
  • Hold an addiction certification from the American Society of Addiction Medicine.
  • Have completed no less than 8 hours of authorized training on the treatment or management of opioid-dependent patients. This training may include classroom situations, seminars at professional society meetings, electronic communications, or other media. The American Society of Addiction Medicine, The American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, and the American Psychiatric Association are all authorized to provide this training.
  • AND meet both of the following criteria:
    1. Have the capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy
    2. Agree to treat no more than 30 patients at any one time in their individual or group practice.
5.How can I be sure a physician is qualified to prescribe Suboxone and Subutex?

Physicians who meet the qualification criteria listed above must also notify the Secretary of Health and Human Services of their intent to prescribe Suboxone and Subutex before doing so. Once all relevant criteria are verified, DEA will issue the physician a unique identification number indicating that he or she is a qualifying physician under the DATA. The Center for Substance Abuse Treatment will send a letter informing the physician of the new DEA identification number. The physician will subsequently receive a revised DEA registration certificate.

6. What if I get a prescription from a doctor who does not have a special DEA identification number?

A special DEA number is not required for physicians prescribing Suboxone/Subutex for the treatment of pain. If this is the case, the prescription must indicate “for pain”. Call that physician for clarification that the physician has made the appropriate notification to DHHS. DEA is developing regulations that will require this number along with the physician's existing DEA registration number to be included on all prescriptions issued for the treatment of opioid dependence; therefore, physicians are being strongly urged to include this number on prescriptions. Most physicians will make arrangements to obtain the identification number before prescribing Suboxone or Subutex, but in rare cases a physician may need to write a prescription before the number has been issued. This is allowed under the DATA provided the physician has notified the Department of Health and Human Services of higher intention to begin treating a patient right away; the notification form includes a check box for this situation.

7. Are there any special storage, record-keeping, or other requirements associated with Suboxone and Subutex?

As Schedule III controlled substances, Suboxone and Subutex are subject to certain federal regulations covering areas such as record-keeping, inventory, proper dispensing, and disposal.



OPERATING A PHARMACY

1.What is the technician to pharmacist ratio for Alabama?

The technician to pharmacist ratio is 3:1, of which one must be certified by a board-approved pharmacy technician certification program.

2.What is the minimum number of hours a pharmacy must be open?

The pharmacy must be open for a minimum of twenty (20) hours per week. A pharmacy may apply to the Board for a waiver or exception under special circumstances. A representative from the pharmacy may be required to appear before the Board in order for this waiver or exception to be considered. A sign in block letters not less than one inch in height shall be displayed either at the main entrance of the establishment or at or near the place where prescriptions are dispensed in a prominent place that is in clear and unobstructed view. Such sign shall state the hours the prescription department is open each day.

3.What does the law state regarding keys to the pharmacy in Alabama?

Any pharmacy doing business within the State of Alabama must be physically enclosed, secured and locked when not open for business, except in the temporary absence of the pharmacist on duty as provided for in §34-23-70(a), Title 34, Chapter 23, Code of Alabama 1975. At all times, registered pharmacists designated by the licensee must have all keys or other controlled access device or method in their possession. The owner of the pharmacy may designate one (1) unregistered person to have a key or other controlled access device or method to the pharmacy and still be considered to be in their possession. The Supervising Pharmacist must agree to this arrangement. The enclosed and secured area must encompass all drugs, products, and devices, the character of which require dispensing or sale by a registered pharmacist, and include store rooms used for receiving or storing these items. The permit holder (owner) must execute a signed agreement with the individual in possession of a key or other controlled access device or method to the pharmacy and must submit a copy to the Board of Pharmacy for approval prior to issuing a key or other controlled access device or method to any person that does not hold an active pharmacist license in the state of Alabama. Forms for this purpose may be obtained from the Board of Pharmacy. Further, if the municipality or other government authority in the jurisdiction where a pharmacy is located requires compliance with a Fire Code that mandates making a key or other controlled access device or method to the premises available to First Responders, the permit holder (owner) must execute a signed agreement with the highest ranking official of the agency that wants access to the key or other controlled access device or method and submit a copy to the Board of Pharmacy for approval prior to providing access to a key or other controlled access device or method; the Knox Box or other system for accessing the key or other controlled access device or method must have a working tamper protection system that is connected to an alarm system that will notify the permit holder (owner) or the supervising pharmacist if an attempt is made to remove the key or other controlled access device or method by unauthorized persons. Where the pharmacist does not have access to the prescription department by other entrances after normal operating hours of the entire store, the owner shall have an action plan that allows the pharmacist to gain access in case of an emergency.

4. If my pharmacy is changing its hours of operation, how soon do I have to notify the public before implementing the change?

There is no law that requires a pharmacy to notify the public a certain time period before implementing its change of operating hours.

5.What does the Alabama law state regarding offering to counsel patients at the pharmacy?

In the best interest of the public health, the patient must be offered counseling for all new prescriptions and, where appropriate, for refill prescriptions. The offer to counsel shall be made by the pharmacist or the pharmacist's designee in a face to face oral communication with the patient, or the patient’s representative, unless in the professional judgment of the pharmacist, it is deemed inappropriate or unnecessary. If it is deemed inappropriate or unnecessary by the pharmacist, it would be permissible for the offer to counsel to be made in a written communication, by telephone, or in a manner determined by the pharmacist to be appropriate. Said counseling must be performed by the pharmacist or properly supervised pharmacist intern. A printed statement shall be included with every prescription listing the pharmacy's telephone number, for the patient to call with questions about their medication.

6. What does the Alabama law state regarding operating a pharmacy during pharmacist breaks?

This rule is to allow pharmacists to have breaks and meal periods without unreasonably impairing the ability of a pharmacy to remain open. In any pharmacy that is staffed by a single pharmacist, the pharmacist may leave the pharmacy area or department, temporarily, for breaks and meal periods without closing the pharmacy and removing interns/externs and technicians from the pharmacy, if the pharmacist reasonably believes that the security of the controlled substances will be maintained in his or her absence. If, in the professional judgment of the pharmacist, the pharmacist determines that the pharmacy should be closed during his or her absence, then the pharmacist shall close the pharmacy area or department and remove all interns/externs and technicians from the pharmacy during his or her absence. During the pharmacist’s temporary absence, no prescription medication may be provided to a patient or to a patient’s agent unless the prescription medication is a new or refill medication that the pharmacist has checked, released for furnishing to the patient and was determined not to require the consultation of a pharmacist. During such times that the pharmacist is temporarily absent from the pharmacy area or department, the interns/externs and technicians may continue to perform the nondiscretionary duties authorized to them by any applicable law or rule. However, any duty performed by an intern/extern or technician shall be reviewed by a pharmacist upon his or her return to the pharmacy. The temporary absence authorized by this rule shall be limited to thirty (30) minutes. The pharmacist shall remain within the facility during the break period and be available to handle all emergency situations. The pharmacy shall have written policies and procedures regarding the operations of the pharmacy area or department during the temporary absence of the pharmacist for breaks and meal periods. The policies and procedures shall include the authorized duties of interns/externs and technicians, the pharmacist’s responsibility for maintaining the security of the pharmacy. The policies and procedures shall be open to inspection by the Board or its designee at all times during business hours.

7. What steps should a pharmacist take in the event of a pharmacy burglary, robbery, or theft?
  • Notify the appropriate local law enforcement agency
  • File a form 106 with the DEA if controlled substances are involved located on the DEA website.
  • Notify the Alabama State Board of Pharmacy
  • Send a copy of DEA 106 form and a copy of the police report to the Alabama State Board of Pharmacy by email or fax.
  • If a theft is committed by an ALBOP licensed pharmacy staff member, report the name and permit or registration number of the member to the state drug inspector assigned to your area.
  • If a theft of non-controlled substances occurs, notify your area ALBOP state drug inspector.


Prescriptions: C-II with Multiple Prescriptions

1.What does the rule state concerning the issuance of multiple prescriptions for schedule II controlled substances?

A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90-day supply of that controlled substance.

2. What are the requirements for the issuance of multiple prescriptions for schedule II controlled substances?

Each prescription issued is for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice. The individual practitioner must provide written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription. The issuance of multiple prescriptions is permissible under applicable state laws. The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and implementing regulations, as well as any additional requirements under state law.

3.Does this rule require or mandate a practitioner to issue multiple prescriptions for schedule II controlled substances?

No. This rule does not require individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days.

4. Is there a limit on the number of schedule II dosage units a practitioner can prescribe to a patient?

There is no federal limit as to the amount of controlled substances a practitioner can legitimately prescribe. However, if a registered practitioner issues multiple schedule II prescriptions, he/she is limited to the combined effect of allowing a patient to receive, over time, up to a 90-day supply of a particular schedule II controlled substance.

5.Is there a limit on the number of separate prescriptions per schedule II controlled substance that may be issued for the 90-day supply?

This rule does not stipulate how many separate prescriptions per schedule II controlled substance may be issued for the 90-day supply. It is up to the practitioner to determine how many separate prescriptions to be filled sequentially are needed to provide adequate medical care. For example, a practitioner may issue three 30-day schedule II prescriptions to cover a 90-day supply or he/she may issue nine prescriptions for the same schedule II controlled substance, each for a ten-day supply, having the combined effect of a 90-day supply.

6. How is the issuance of multiple schedule II prescriptions different than issuing a refill of a schedule II prescription?

The issuance of refills for a schedule II controlled substance is prohibited by law. The use of multiple prescriptions for the dispensing of schedule II controlled substances, under the conditions set forth in the Final Rule, ensures that the prescriptions are treated as separate dispensing documents, not refills of an original prescription. Each separate prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Each separate prescription must contain written instructions indicating the earliest date on which a pharmacy may fill each prescription.

7. Is post-dating of multiple prescriptions allowed?

No. Federal regulations have always required that all prescriptions for controlled substances “be dated as of, and signed on, the day when issued.”

What is expected of the pharmacist when filling a prescription issued pursuant to this regulation?

Where a prescription contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. In addition, when filling any prescription for a controlled substance, a pharmacist who fills multiple prescriptions issued in accordance with this regulation has a corresponding responsibility to ensure that each sequential prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.



Refusal to Fill

1. What grounds are listed in the Board rule on refusing to fill or refill a prescription?

Pharmacists may refuse to fill or refill prescriptions if they believe it would be harmful to the patient, if there’s a question as to its validity, or they believe it is not in the patient’s best interest.



Emergency Refills

1. Can a pharmacist give an emergency refill on a weekend if a patient needs it when there are no refills left on the prescription?

In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber, the pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication, providing that:

  • The prescription is not a medicinal agent listed in Schedule II appearing in Title 20, chapter 2.
  • The medication is essential to the maintenance of life or the continuation of therapy in a chronic condition. Only those drugs designed by a joint rule adopted by the board of pharmacy and the board of medical examiners shall be refilled, according to the procedure established in this section
  • The dispensing pharmacist created a written order containing all the prescription information required by this chapter and Title 20, Chapter 2.
  • The dispensing pharmacist notifies the prescriber of the emergency dispensing within 72 hours after such dispensing.


MEDICATION SAFETY: SHARPS AND SHARPS CONTAINERS

1.What safety precautions should I be aware of when using sharps?

Sharps is a medical term for devices with sharp points or edges that can puncture or cut skin. They may be used at home, at work, and while traveling to manage the medical conditions of people or their pets, including allergies, arthritis, cancer, diabetes, hepatitis, HIV/AIDS, infertility, migraines, multiple sclerosis, osteoporosis, blood clotting disorders, and psoriasis. Sharps Include:

  • Needles: hollow needles used to inject drugs under the skin
  • Syringes: devices used to inject medication into or withdraw fluid from the body
  • Lancets/ “fingerstick” devices: instruments with a short, two-edged blade used to get drops of blood for testing
  • Auto Injectors: syringes pre-filled with fluid medication designed to be selfinjected into the body (ex: epinephrine and insulin pens)
  • Infusion sets: tubing systems with a needle used to deliver drugs to the body.

Used sharps should be immediately placed in a sharps disposal container. FDA-cleared sharps containers are generally available through pharmacies, medical supply companies, and health care providers and online. These containers are made of puncture-resistant plastic with leakresistant sides and bottom. They also have a tight fitting, puncture-resistant lid

If an FDA-cleared container is not available a heavy-duty plastic household container, such as a laundry detergent container can be used as an alternative

2.What precautions should I take when disposing of sharps?

Never place loose needles and other sharps (those that are not placed in a Sharps disposal container) in the household or public trash cans or recycling bins, and never flush them down the toilet. This puts trash and sewage workers, janitors, housekeepers, household members, and children at risk of being harmed.

Pet owners who use needles to give medicine to their pets should follow the same sharps disposal guidelines used for humans.

3.What should I do if I am accidentally stuck by used needle or other sharp?

If you are accidentally stuck by another person’s used needle or other sharp:

  • Wash the exposed area right away with water and soap or use a skin disinfectant (antiseptic) such as rubbing alcohol or hand sanitizer.
  • Seek immediate medical attention by calling your physician or local hospital

Follow these same instructions if you get blood or other bodily fluids in your eyes, nose, mouth, or on your skin

4. Where can I find more information on safety measures with sharps?

Below are links to FDA information regarding safety measures when using various sharp instruments:

  • HTTP://WWW.FDA.GOV/MEDICALDEVICES/PRODUCTSANDMEDICALPROCEDURES/HOMEHEALTHANDCONSUMER/CONSUMERPRODUCTS/SHARPS/
  • HTTP://WWW.FDA.GOV/FORCONSUMERS/CONSUMERUPDATES/UCM101653.HTM


Over the Counter Medications

1.May syringes be sold in Alabama without a prescription?

Yes, syringes may be sold in Alabama without a prescription. There are a few states which still require prescriptions as part of paraphernalia laws, and some states have age restrictions on purchasing syringes. A pharmacist always has the right to deny a sale which the pharmacist believes is not appropriate.

2.What are the Alabama restrictions on the sale of ephedrine or pseudoephedrine containing products?

These products must be sold by a pharmacy licensed by ALBOP from behind the counter and a person may purchase no more than 3.6 grams per calendar day and no more than 7.5 grams per 30 days (AL law). Purchaser must be at least 18 years of age and provide a valid, unsuspended driver’s license or non-driver ID card issued by one of the 50 states, a U.S. Uniformed Services Privilege and ID card or a US or foreign passport.

3.Does Alabama law require a “wet signature” or hand signed signature on prescriptions given to the patient for non-controlled drugs?

Please note sections (4) and (7). As you will read, this law refers to “Every written prescription issued in this State by a licensed practitioner”…….and “the practitioner shall communicate the instructions to the pharmacist by SIGNING on the appropriate line.” It does not limit the prescriptions to Controlled Substances only. Also, please note (7) specifies the punishment that could result from violations of this law. This particular law is part of the State Pharmacy Practices Act, not the Medical Practices Act. I can tell you that any time a prescription is printed out from a fax machine and provided to a patient to take to a pharmacy, or defaults to a pharmacy’s fax machine for filling, it is not an “Electronic Prescription.” That prescription becomes an original / hard copy prescription and it must have an original / “wet signature” on it. That means that if it is faxed to a pharmacy, or if it is understood that it will default to the pharmacy’s fax machine, you must stop the transmission of the prescription, sign the prescription and then you can send it on to the pharmacy. You stated that the patients are advising that the prescriptions are “not being honored” by a pharmacy. When this is the case, you need to sign the EMR prescription before giving it to the patient



PRESCRIPTIONS: CONTROLLED SUBSTANCES

1. What are the requirements for schedule II controlled substances?

Schedule II controlled substances require a written prescription which must be manually signed by the practitioner or an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances.

2. Is there a time limit within which a schedule II prescription must be filled after being signed by the practitioner?

No. However, the pharmacist should determine that the prescription is still needed by the patient.

3. Is there a limit to the quantity of controlled substances dispensed to a 30-day supply?

No. While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no expressed federal limits with respect to the quantities of drugs dispensed via a prescription. However, the amount dispensed must be consistent with the requirement that a prescription for a controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

4. Is an oral order for a schedule II controlled substance permitted?

No. Only in an emergency situation is an oral order for a schedule II controlled substance permitted. The physician must provide a hard copy of the prescription within 72 hours. If the prescriber does not provide said hard copy, the pharmacist is responsible for contacting the DEA.

5. What items may be changed on a Schedule II prescription?

Since there are no direct rulings in Alabama Pharmacy Statues, Alabama pharmacists may refer to the DEA Diversion Website, which states a pharmacist may change or add the dosage form, drug strength, drug quantity, direction for use, or issue date only after consultation with and agreement of the prescribing practitioner. Dates for prescriptions which are dated for later fill may be changed with permission of the physician.

6. What information is required on a prescription for a controlled substance?

A prescription for a controlled substance must include the following information:

  • Date of issue
  • Patient's name and address
  • Practitioner's name, address, and DEA registration number
  • Drug name
  • Drug strength
  • Dosage form
  • Quantity prescribed
  • Directions for use
  • Number of refills (if any) authorized
  • Manual signature of prescriber

A prescription must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner. An individual may be designated by the practitioner to prepare the prescriptions for his/her signature. The practitioner is responsible for making sure that the prescription conforms in all essential respects to the law and regulation.

Prescriptions for schedule II controlled substances must be written and be signed by the practitioner. In emergency situations, a prescription for a schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription being sent to the pharmacy within seven days. Prescriptions for schedules III through V controlled substances may by written, oral or transmitted by fax.

7. May a prescriber use an electronic signature in preparing a prescription?

In Alabama, a prescription which is printed or prepared in the prescriber’s office for a controlled drug may NOT have a signature from the printer, or an electronic signature. All prepared or hard copy prescriptions for controlled substances must have a “wet” signature. This means the prescription must be signed manually.

8. Can controlled substance prescriptions be refilled?

Prescriptions for schedule II controlled substances cannot be refilled. A new prescription must be issued. Prescriptions for schedules III and IV controlled substances may be refilled up to five times in six months. Prescriptions for schedule V controlled substances may be refilled as authorized by the practitioner.

9. Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in a greater number of dispensations than the number of refills indicated on the prescription?

Yes. Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue.

10. Can controlled substance prescriptions for hospice patients be faxed to a pharmacy?

A prescription written for a schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.

A pharmacist may dispense directly a controlled substance listed in schedules III, IV, or V pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist.

11. Is it appropriate to provide a DEA registration number on prescriptions written for medications other than controlled substances?

DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. Although DEA has repeatedly made its position known to industries such as insurance providers and pharmacy benefit managers, there is currently no legal basis for DEA to prevent or preclude companies from requiring or requesting a practitioner's DEA registration number.

The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final Rule was May 23, 2005; all covered entities were to begin using the NPI in standard transactions by May 23, 2007. A contingency extension was provided to covered entities unable to meet the 2007 deadline. Contingency plans were to not extend beyond May 23, 2008

12. What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?

On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally."

The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations*** or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.

Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.

***ALABAMA PERMITS THE SAME CHANGES AS MAY BE MADE TO A SCHEDULE III-V.

13. What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?

The pharmacist may add or change the patient's address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.

The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.

14. Can a practitioner prescribe methadone for the treatment of pain?

Federal law and regulations do not restrict the prescribing, dispensing, or administering of any schedule II, III, IV, or V narcotic medication, including methadone, for the treatment of pain, if such treatment is deemed medically necessary by a registered practitioner acting in the usual course of professional practice.

Confusion often arises due to regulatory restrictions concerning the use of methadone for the maintenance or detoxification of opioid addicted individuals, in which case the practitioner is required to be registered with the DEA as a Narcotic Treatment Program (NTP).

15. Can an individual return his/her controlled substance prescription medication to a pharmacy?

No. An individual patient may not return his/her unused controlled substance prescription medication to the pharmacy. Federal laws and regulations make no provisions for an individual to return the controlled substance prescription medication to a pharmacy for further dispensing or for disposal. There are no provisions in the Controlled Substances Act or Code of Federal Regulations (CFR) for a DEA registrant (i.e., retail pharmacy) to acquire controlled substances from a non-registrant (i.e., individual patient).

The CFR does have a provision for an individual to return his/her unused controlled substance medication to the pharmacy in the event of the controlled substance being recalled or a dispensing error has occurred.

An individual may dispose of his/her own controlled substance medication without approval from DEA. Medications should be disposed of in such a manner that does not allow for the controlled substances to be easily retrieved. In situations where an individual has expired, a caregiver or hospice staff member may assist the family with the proper disposal of any unused controlled substance medications.

16. Under what conditions can a controlled substance prescription, CII-CV be issued electronically (E-prescribing)?

Yes you may accept e-prescribed control drugs. In order for a controlled substance prescription to be valid electronically (E-scribing), both the prescriber and pharmacy must use DEA approved software and have a certificate stating they have been approved. (More detail via DEA pharmacist manual: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html)

17.What changes may be made to a CII prescription?

CII prescription (Federal): “When information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.” (More detail at http://www.deadiversion.usdoj.gov/faq/prescriptions.htm#rx-7)

CII prescription (State): A pharmacist may add or change the patient’s address upon verification. A pharmacist may add or change dosage form, drug strength, drug quantity, or directions for use or issue date only after consultation with and agreement of the prescribing practitioner. Any consultation and changes should be documented by the pharmacist on the prescription. (For state see “Controlled Substance Rules and Regulations Quick Reference” on albop.com)

18. What changes may be made to a CIII- CV prescription?

CIII, IV, V (State): A pharmacist may add/ change dosage form, strength, quantity, directions, issue date, or patient address only after speaking with prescriber and documenting on the prescription. If the prescription is missing the prescriber’s signature, pharmacist must then forfeit the written prescription and take a new one verbally and reduce to writing.

19. Can you do a partial fill on a CII prescription?

Yes, but it must be documented on the prescription and the remaining balance must be filled within 72 hours of partially filling. If it is not filled within the 72 hours, the remaining balance is forfeited and a new prescription is required. EXCEPTIONS: For long-term care facilities (LTCF) and patients with diagnosis of terminal illness.

20. Can a prescription for Suboxone be called in and what number must be obtained from the doctor for the prescription to be valid?

Yes, Suboxone is a CIII prescription and may be called in but does have necessary requirements in order to be valid. If the prescription is for opioid addiction, the prescriber must be a qualified physician and provide a DEA number with an “X’ in front of it to confirm prescriber has certified authorization. If it is for the treatment of pain the physician’s DEA number is required.

21. For how long is a CII prescription valid?

A CII prescription does not have an expiration date in the state of Alabama.

22. For how long is a CIII and CIV, prescription valid?

CIII through CIV prescriptions expire 6 months from the date written or after 5 refills (if permitted), whichever comes first.

23. What are the limits of time and refills on CV prescriptions?

There are no written limits on CV prescriptions for time or refills.

24. Should an Alabama pharmacy honor a CII prescription from an out-of-state nurse practitioner?

Yes, because registered nurse practitioners have prescriptive authority to prescribe a CII in the state of Alabama.

25. May a prescriber write multiple CII prescriptions for the same patient and same medication on same day office visit?

Yes, the patient may receive multiple prescriptions but the current date must be written on all of the prescriptions, it cannot exceed a 90 day supply, and it may not be postdated. The prescriber may put instructions in the body of the prescription that says to fill on or after a specific date.

26. Can a pharmacist fill an emergency prescription refill for a CII?

No, a CII cannot be refilled without a new valid written prescription. EXCEPTION: In an emergency situation a pharmacist may dispense a CII for a resident of a long-term care facility, a patient receiving hospice services, or a patient receiving home health care services pursuant to an emergency oral prescription transmitted by a prescriber. The quantity dispensed is limited to the amount necessary to adequately treat the patient during the emergency period and not to exceed 72 hours. The prescriber must then provide the pharmacy with a written prescription with 7 days of the emergency orally transmitted prescription. The written prescription must have “Authorization for Emergency Dispensing” and the date of the oral order written on it and it needs to be attached with the written verbal order previously taken by the pharmacist. (Code of Alabama: Title 20 Chapter 2 Article 3 Section 58)

27. Can you use a partially/ fully pre-populated refill request form for a controlled substance?

No, because the practitioner must determine whether or not there is a legitimate medical purpose for the prescription.

28. Is there an expiration for schedule III substances?

Prescriptions for Schedule III substances expire 6 months after the date written. There may be 5 refills within the 6-month period. Refill authorization can be transferred from one pharmacy to another once within the 6-month period. A practitioner may issue a new prescription for the Schedule III substance within a 6-month period if necessary.

29. Can a pharmacist partially fill a prescription for a controlled substance?

A pharmacist may partially fill a prescription for controlled substances. If the remainder is not dispensed to the patient within the following 72 hours, the prescription is void and must be rewritten in order for the patient to get the remainder. Partial refills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e. date refilled, amount dispensed, initials of dispensing pharmacist, etc), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after 6 months past the date of issue" (21 CFR Section 1306.13).

30. Are refills permitted for controlled substances?

Prescriptions for Schedule II controlled substances cannot be refilled. A new prescription must be issued. However, an authorized prescriber may prepare multiple prescriptions on the same day with instructions to fill on different dates. Prescriptions for Schedule III through V controlled substances may be refilled up to 5 times in 6 months. The prescription may be telephoned or transmitted via facsimile to the pharmacy. Office staff may communicate the information to the pharmacy when acting as an agent of the registered physician (21 CFR 1306.12).

31. What is the proper way to handle emergency situations?

Emergency is defined by the Secretary of Health and Human Services as "situations in which the prescribing practitioner determines that: (1) immediate administration of a controlled substance is necessary, for proper treatment of the intended ultimate user; (2) that no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and (3) it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing" (21 CFR 290.10).

In emergency situations, a prescription for a Schedule II controlled substance may be telephoned to the pharmacy and the prescriber must follow up with a written prescription sent to the pharmacy within 7 days. (States may require that the prescription be sent to the pharmacist in a shorter time frame.) Prescriptions for Schedule III through V controlled substances may by written or transmitted orally or by fax.

Here are some additional requirements to heed when orally transmitting prescriptions in emergency situations: "In an emergency, the prescriber may give an oral prescription for a Schedule II drug if the pharmacist makes a reasonable effort to identify the prescriber and the amount is limited to what is necessary to treat the patient during the emergency. The prescriber must cause to be delivered an original prescription to the dispensing pharmacist within 7 days. The prescriber must write 'Authorization for Emergency Dispensing' on the prescription. The prescriber must document how the situation met the criteria for emergency treatment" (21 CFR 290.10).

32. Is it permissible to fax prescriptions for controlled substances?

Prescriptions may be faxed under certain conditions. Here are the conditions, as stated in federal regulations: "A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with Sec. 1304.04 (h) of this chapter.

"(e) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with Sec. 1304.04(h) of this chapter" (21 CFR Section 1306.11).

Therefore, Schedule II prescriptions can be faxed to a pharmacist, but the copy is just an alert to the pharmacist that the patient is end route with an original prescription.

Schedule III and IV prescriptions may be telephoned in or faxed to the pharmacist, or the practitioner could go to the pharmacy counter and request that a drug be dispensed to a patient. In the latter case, the pharmacist would have the responsibility of reducing the verbal order to writing. Here is the legal language: "A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner" (21 CFR Section 1306.21[a]).

33. Does Alabama have a Prescription Drug Monitoring Program (PDMP) and who has access?

Yes, licensed prescribers, dispensers, and law enforcement all have potential access to the PDMP. In order to gain access you must be a licensed physician, physician assistant, or pharmacist in the state of Alabama and fill out the appropriate application.



STERILE COMPOUNDING

1. What is the “immediate use” exemption?

Three of fewer sterile products may be prepared in worse than ISO Class 5 air when there is no director contact contamination, and administration begins within 1 hours and is completed within 12 hours of preparation

2.What is an FDA Outsourcing facility?

Federal law defines an outsourcing facility as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of Section 503B (of the DQSA).

An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directors for us, but not the exemption from current good manufacturing practice (cGMP) requirements.

Outsourcing facilities:

  • Must comply with cGMP requirements
  • Will be inspected by FDA according to a risk-based schedule
  • Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound
3. If a commercially available FDA product is available, what would the Board of Pharmacy’s position be on compounding the same material using USP 797 conditions instead of buying the commercially available product?

Please be advised that you may not compound a prescription for a medication that is readily and commercially available. The Food and Drug Administration Modernization Act of 1997 (FDAMA) prohibits pharmacists from compounding “essentially copies” of commercially available drug products.

4.May a pharmacy provide samples of compounded medications to physicians and provide compounded medications of non-commercial products for use by physician in office?

Compounding is only allowed pursuant to a patient-specific prescription. If you would like to perform office use compounding, you should be registered with the FDA as an outsourcing facility.

5.How often must one successfully complete written and media- fill testing when preparing low or medium-risk compounded sterile products (CSPs)?

Annually

6. How often must one successfully complete written and media-fill testing when preparing high- risk compounded sterile products (CSPs)?

Semi-annually

7.Which type CSP risk level can be prepared for immediate use?

Only low-risk CSPs may be compounded for immediate use.

8. How soon must an immediate use, low-risk CSP be used?

The immediate use, low-risk compound must be administered within one hour or less from the start of preparation. Otherwise, the preparation must be discarded.

9. Can a single- dose or single- use vial be used for more than one patient?

No, vials that are labeled single- dose/use, are only to be used once for an individual patient.

10. How many times can you access a single- dose or single-use vial for a single patient?

You should only enter the vial once to prevent contamination.

11. What is the maximum beyond- use date for a single use container (i.e. bags, bottles, vials, etc.)?

The maximum beyond-use date is six hours after entry into the vial, if the vial is entered in at least an ISO Class 5 environment. If it's entered in less than an ISO Class 5 environment (i.e. 6), the maximum beyond-use date is one hour.

12.Can I prepare sterile and non- sterile compounds in the same?

No, there must be two distinct, separate areas, one for sterile compounding preparation and another for non-sterile compounding preparation. (See USP 797 Environmental and Quality Control)

13. What are some of the drugs that have been identified as “hazardous drugs”?

Testosterone, Estrogen, Progesterone, Chemotherapy (More info and a more through list of medications can be found at: http://www.cdc.gov/niosh/topics/hazdrug/).** Employees handling these medications must sign a consent form stating they have been trained on proper handling and they understand the potential risks associated**

14. What type of sink is required if in the ante-room?

There may be a hands-free sink located in the ante-room with either a sensor, foot pedal, or something of that nature. (Information located: USP 797 “Additional requirements”).

15.What are the requirements for the ceilings where sterile products are prepared and/or compounded?

“Junctures of ceilings to walls shall be coved or caulked to avoid cracks and crevices where dirt can accumulate. If ceilings consist of inlaid panels, the panels shall be impregnated with a polymer to render them impervious and hydrophobic, and they shall be caulked around each perimeter to seal them to the support frame.” (Information located: USP 797 “Facility Design and Environmental Controls”)

16.What type of environment must I weigh or mix non- sterile products in?

An ISO 8 environment or better (i.e. 7)

17.How many air exchanges are required in both the buffer and ante rooms per hour?

A minimum of 30 air- exchanges per hour

18. Can a pass-through be used between the buffer room and the general pharmacy?

General Chapter <797> does not specifically address pass-through from a cleanroom to an unclassified room. Ideally, a pass-through should have interlocks to prevent both doors from being open at the same time, therefore preventing transfer of contamination during material transfer. The suitability of using the pass-through should be supported by environmental monitoring. The buffer room should be evaluated for viable and nonviable particles during static operations. If the buffer room has a pass-through, it should be used during the time of evaluation to determine the impact of ISO 7 air.

19. What will an inspector be looking at during an inspection of a sterile compounding facility?

The inspector will be reviewing policies and procedures; training logs, including Glover finger testing, aseptic technique, and cleaning; cleaning logs; temperature logs; observed compounding procedures; compounding logs; and room(s) and hood(s) certifications.

20. Where must a pressure meter be placed when conducting sterile compounding?

A pressure meter is needed where the ante room connects to general pharmacy and if there is a wall between the buffer and ante room, a pressure sensor is needed there too. If there is no wall between the ante and buffer rooms then there needs to be a velocity meter at the division line between buffer and ante-room.